FILE s830.

enr --S.830--S.830

 

An Act To amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the regulation of food, drugs, devices, and biological products, and for other purposes.

 

This Act may be cited as the 'Food and Drug Administration Modernization Act of 1997'

SUBTITLE A--FEES RELATING TO DRUGS

SEC. 101. Findings

SEC. 102. Definitions

SEC. 103. Authority to assess and use drug fees

SEC. 104. Annual reports

SEC. 105. Savings

SEC. 106. Effective date

SEC. 107. Termination of effectiveness

 

SUBTITLE B--OTHER IMPROVEMENTS

SEC. 111. Pediatric studies of drugs

SEC. 112. Expediting study and approval of fast track drugs

SEC. 113. Information program on clinical trials for serious or life-threatening diseases

SEC. 114. Health care economic information

SEC. 115. Clinical investigations

SEC. 116. Manufacturing changes for drugs

SEC. 117. Streamlining clinical research on drugs

SEC. 118. Data requirements for drugs and biologics

SEC. 119. Content and review of applications

SEC. 120. Scientific advisory panels

SEC. 121. Positron emission tomography

SEC. 122. Requirements for radiopharmaceuticals

SEC. 123. Modernization of regulation

SEC. 124. Pilot and small scale manufacture

SEC. 125. Insulin and antibiotics

SEC. 126. Elimination of certain labeling requirements

SEC. 127. Application of Federal law to practice of pharmacy compounding

SEC. 128. Reauthorization of clinical pharmacology program

SEC. 129. Regulations for sunscreen products

SEC. 130. Reports of postmarketing approval studies

SEC. 131. Notification of discontinuance of a life saving product

SEC. 101. FINDINGS

Congress finds that--

(1) prompt approval of safe and effective new drugs and other therapies is critical to the improvement of the public health so that patients may enjoy the benefits provided by these therapies to treat and prevent illness and disease;

(2) the public health will be served by making additional funds available for the purpose of augmenting the resources of the Food and Drug Administration that are devoted to the process for review of human drug applications;

(3) the provisions added by the Prescription Drug User Fee Act of 1992 have been successful in substantially reducing review times for human drug applications and should be-- (A) reauthorized for an additional 5 years, with certain technical improvements; and (B) carried out by the Food and Drug Administration with new commitments to implement more ambitious and comprehensive improvements in regulatory processes of the Food and Drug Administration; and

(4) the fees authorized by amendments made in this subtitle will be dedicated toward expediting the drug development process and the review of human drug applications as set forth in the goals identified, for purposes of part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act, in the letters from the Secretary of Health and Human Services to the chairman of the Committee on Commerce of the House of Representatives and the chairman of the Committee on Labor and Human Resources of the Senate, as set forth in the Congressional Record.

Section 735 (21 U.S.C. 379g) is amended--

(1) in the second sentence of paragraph (1)-- (A) by striking 'Service Act, and' and inserting 'Service Act,'; and (B) by striking 'September 1, 1992.' and inserting the following: 'September 1, 1992, does not include an application for a licensure of a biological product for further manufacturing use only, and does not include an application or supplement submitted by a State or Federal Government entity for a drug that is not distributed commercially. Such term does include an application for licensure, as described in subparagraph (D), of a large volume biological product intended for single dose injection for intravenous use or infusion.';

(2) in the second sentence of paragraph (3)-- (A) by striking 'Service Act, and' and inserting 'Service Act,'; and (B) by striking 'September 1, 1992.' and inserting the following: 'September 1, 1992, does not include a biological product that is licensed for further manufacturing use only, and does not include a drug that is not distributed commercially and is the subject of an application or supplement submitted by a State or Federal Government entity. Such term does include a large volume biological product intended for single dose injection for intravenous use or infusion.';

(3) in paragraph (4), by striking 'without' and inserting 'without substantial';

(4) by amending the first sentence of paragraph (5) to read as follows:

'(5) The term 'prescription drug establishment' means a foreign or domestic place of business which is at one general physical location consisting of one or more buildings all of which are within five miles of each other and at which one or more prescription drug products are manufactured in final dosage form.';

(5) in paragraph (7)(A)-- (A) by striking 'employees under contract' and all that follows through 'Administration,' the second time it occurs and inserting 'contractors of the Food and Drug Administration,'; and (B) by striking 'and committees,' and inserting 'and committees and to contracts with such contractors,';

(6) in paragraph (8)-- (A) in subparagraph (A)-- (i) by striking 'August of' and inserting 'April of'; and (ii) by striking 'August 1992' and inserting 'April 1997'; and (B) in subparagraph (B)-- (i) by striking 'section 254(d)' and inserting 'section 254(c)'; (ii) by striking '1992' and inserting '1997'; and (iii) by striking '102d Congress, 2d Session' and inserting '105th Congress, 1st Session'; and

(7) by adding at the end the following:

'(9) The term 'affiliate' means a business entity that has a relationship with a second business entity if, directly or indirectly-- '(A) one business entity controls, or has the power to control, the other business entity; or '(B) a third party controls, or has power to control, both of the business entities.'

(a) TYPES OF FEES- Section 736(a) (21 U.S.C. 379h(a)) is amended--

(1) by striking 'Beginning in fiscal year 1993' and inserting 'Beginning in fiscal year 1998';

(2) in paragraph (1)-- (A) by striking subparagraph (B) and inserting the following: '(B) PAYMENT- The fee required by subparagraph (A) shall be due upon submission of the application or supplement.'; (B) in subparagraph (D)-- (i) in the subparagraph heading, by striking 'NOT ACCEPTED' and inserting 'REFUSED'; (ii) by striking '50 percent' and inserting '75 percent'; (iii) by striking 'subparagraph (B)(i)' and inserting 'subparagraph (B)'; and (iv) by striking 'not accepted' and inserting 'refused'; and (C) by adding at the end the following: '(E) EXCEPTION FOR DESIGNATED ORPHAN DRUG OR INDICATION- A human drug application for a prescription drug product that has been designated as a drug for a rare disease or condition pursuant to section 526 shall not be subject to a fee under subparagraph (A), unless the human drug application includes an indication for other than a rare disease or condition. A supplement proposing to include a new indication for a rare disease or condition in a human drug application shall not be subject to a fee under subparagraph (A), if the drug has been designated pursuant to section 526 as a drug for a rare disease or condition with regard to the indication proposed in such supplement.

'(F) EXCEPTION FOR SUPPLEMENTS FOR PEDIATRIC INDICATIONS- A supplement to a human drug application proposing to include a new indication for use in pediatric populations shall not be assessed a fee under subparagraph (A).

'(G) REFUND OF FEE IF APPLICATION WITHDRAWN- If an application or supplement is withdrawn after the application or supplement was filed, the Secretary may refund the fee or a portion of the fee if no substantial work was performed on the application or supplement after the application or supplement was filed. The Secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this paragraph shall not be reviewable.';

(3) by striking paragraph (2) and inserting the following:

'(2) PRESCRIPTION DRUG ESTABLISHMENT FEE- '(A) IN GENERAL- Except as provided in subparagraph (B), each person that-- '(i) is named as the applicant in a human drug application; and '(ii) after September 1, 1992, had pending before the Secretary a human drug application or supplement, shall be assessed an annual fee established in subsection (b) for each prescription drug establishment listed in its approved human drug application as an establishment that manufactures the prescription drug product named in the application. The annual establishment fee shall be assessed in each fiscal year in which the prescription drug product named in the application is assessed a fee under paragraph (3) unless the prescription drug establishment listed in the application does not engage in the manufacture of the prescription drug product during the fiscal year. The establishment fee shall be payable on or before January 31 of each year. Each such establishment shall be assessed only one fee per establishment, notwithstanding the number of prescription drug products manufactured at the establishment. In the event an establishment is listed in a human drug application by more than one applicant, the establishment fee for the fiscal year shall be divided equally and assessed among the applicants whose prescription drug products are manufactured by the establishment during the fiscal year and assessed product fees under paragraph (3).

'(B) EXCEPTION- If, during the fiscal year, an applicant initiates or causes to be initiated the manufacture of a prescription drug product at an establishment listed in its human drug application-- '(i) that did not manufacture the product in the previous fiscal year; and '(ii) for which the full establishment fee has been assessed in the fiscal year at a time before manufacture of the prescription drug product was begun; the applicant will not be assessed a share of the establishment fee for the fiscal year in which the manufacture of the product began.'; and

(4) in paragraph (3)-- (A) in subparagraph (A)-- (i) in clause (i), by striking 'is listed' and inserting 'has been submitted for listing'; and (ii) by striking 'Such fee shall be payable' and all that follows through 'section 510.' and inserting the following: 'Such fee shall be payable for the fiscal year in which the product is first submitted for listing under section 510, or is submitted for relisting under section 510 if the product has been withdrawn from listing and relisted. After such fee is paid for that fiscal year, such fee shall be payable on or before January 31 of each year. Such fee shall be paid only once for each product for a fiscal year in which the fee is payable.'; and (B) in subparagraph (B), by striking '505(j).' and inserting the following: '505(j), under an abbreviated application filed under section 507 (as in effect on the day before the date of enactment of the Food and Drug Administration Modernization Act of 1997), or under an abbreviated new drug application pursuant to regulations in effect prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984.'

(b) FEE AMOUNTS- Section 736(b) (21 U.S.C. 379h(b)) is amended to read as follows: '(b) FEE AMOUNTS- Except as provided in subsections (c), (d), (f), and (g), the fees required under subsection (a) shall be determined and assessed as follows:

'(1) APPLICATION AND SUPPLEMENT FEES- '(A) FULL FEES- The application fee under subsection (a)(1)(A)(i) shall be $250,704 in fiscal year 1998, $256,338 in each of fiscal years 1999 and 2000, $267,606 in fiscal year 2001, and $258,451 in fiscal year 2002.

'(B) OTHER FEES- The fee under subsection (a)(1)(A)(ii) shall be $125,352 in fiscal year 1998, $128,169 in each of fiscal years 1999 and 2000, $133,803 in fiscal year 2001, and $129,226 in fiscal year 2002.

'(2) TOTAL FEE REVENUES FOR ESTABLISHMENT FEES- The total fee revenues to be collected in establishment fees under subsection (a)(2) shall be $35,600,000 in fiscal year 1998, $36,400,000 in each of fiscal years 1999 and 2000, $38,000,000 in fiscal year 2001, and $36,700,000 in fiscal year 2002.

'(3) TOTAL FEE REVENUES FOR PRODUCT FEES- The total fee revenues to be collected in product fees under subsection (a)(3) in a fiscal year shall be equal to the total fee revenues collected in establishment fees under subsection (a)(2) in that fiscal year.'

(c) INCREASES AND ADJUSTMENTS- Section 736(c) (21 U.S.C. 379h(c)) is amended--

(1) in the subsection heading, by striking 'INCREASES AND';

(2) in paragraph (1)-- (A) by striking '(1) REVENUE' and all that follows through 'increased by the Secretary' and inserting the following: '(1) INFLATION ADJUSTMENT- The fees and total fee revenues established in subsection (b) shall be adjusted by the Secretary'; (B) in subparagraph (A), by striking 'increase' and inserting 'change'; (C) in subparagraph (B), by striking 'increase' and inserting 'change'; and (D) by adding at the end the following flush sentence: 'The adjustment made each fiscal year by this subsection will be added on a compounded basis to the sum of all adjustments made each fiscal year after fiscal year 1997 under this subsection.';

(3) in paragraph (2), by striking 'October 1, 1992,' and all that follows through 'such schedule.' and inserting the following: 'September 30, 1997, adjust the establishment and product fees described in subsection (b) for the fiscal year in which the adjustment occurs so that the revenues collected from each of the categories of fees described in paragraphs (2) and (3) of subsection (b) shall be set to be equal to the revenues collected from the category of application and supplement fees described in paragraph (1) of subsection (b).'; and

(4) in paragraph (3), by striking 'paragraph (2)' and inserting 'this subsection'.

(d) FEE WAIVER OR REDUCTION- Section 736(d) (21 U.S.C. 379h(d)) is amended--

(1) by redesignating paragraphs (1), (2), (3), and (4) as subparagraphs (A), (B), (C), and (D), respectively and indenting appropriately;

(2) by striking 'The Secretary shall grant a' and all that follows through 'finds that--' and inserting the following:

'(1) IN GENERAL- The Secretary shall grant a waiver from or a reduction of one or more fees assessed under subsection (a) where the Secretary finds that--';

(3) in subparagraph (C) (as so redesignated in paragraph (1)), by striking ', or' and inserting a comma;

(4) in subparagraph (D) (as so redesignated in paragraph (1)), by striking the period and inserting ', or';

(5) by inserting after subparagraph (D) (as so redesignated in paragraph (1)) the following: '(E) the applicant involved is a small business submitting its first human drug application to the Secretary for review.'; and

(6) by striking 'In making the finding in paragraph (3),' and all that follows through 'standard costs.' and inserting the following:

'(2) USE OF STANDARD COSTS- In making the finding in paragraph (1)(C), the Secretary may use standard costs.

'(3) RULES RELATING TO SMALL BUSINESSES- '(A) DEFINITION- In paragraph (1)(E), the term 'small business' means an entity that has fewer than 500 employees, including employees of affiliates.

'(B) WAIVER OF APPLICATION FEE- The Secretary shall waive under paragraph (1)(E) the application fee for the first human drug application that a small business or its affiliate submits to the Secretary for review. After a small business or its affiliate is granted such a waiver, the small business or its affiliate shall pay-- '(i) application fees for all subsequent human drug applications submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business; and '(ii) all supplement fees for all supplements to human drug applications submitted to the Secretary for review in the same manner as an entity that does not qualify as a small business.'

(e) ASSESSMENT OF FEES- Section 736(f)(1) (21 U.S.C. 379h(f)(1)) is amended--

(1) by striking 'fiscal year 1993' and inserting 'fiscal year 1997'; and

(2) by striking 'fiscal year 1992' and inserting 'fiscal year 1997 (excluding the amount of fees appropriated for such fiscal year)'

(f) CREDITING AND AVAILABILITY OF FEES- Section 736(g) (21 U.S.C. 379h(g)) is amended--

(1) in paragraph (1), by adding at the end the following: 'Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of human drug applications.';

(2) in paragraph (2)-- (A) in subparagraph (A), by striking 'Acts' and inserting 'Acts, or otherwise made available for obligation,'; and (B) in subparagraph (B), by striking 'over such costs for fiscal year 1992' and inserting 'over such costs, excluding costs paid from fees collected under this section, for fiscal year 1997'; and

(3) by striking paragraph (3) and inserting the following:

'(3) AUTHORIZATION OF APPROPRIATIONS- There are authorized to be appropriated for fees under this section-- '(A) $106,800,000 for fiscal year 1998; '(B) $109,200,000 for fiscal year 1999; '(C) $109,200,000 for fiscal year 2000; '(D) $114,000,000 for fiscal year 2001; and '(E) $110,100,000 for fiscal year 2002, as adjusted to reflect adjustments in the total fee revenues made under this section and changes in the total amounts collected by application, supplement, establishment, and product fees.

'(4) OFFSET- Any amount of fees collected for a fiscal year under this section that exceeds the amount of fees specified in appropriation Acts for such fiscal year shall be credited to the appropriation account of the Food and Drug Administration as provided in paragraph (1), and shall be subtracted from the amount of fees that would otherwise be authorized to be collected under this section pursuant to appropriation Acts for a subsequent fiscal year.'

(g) REQUIREMENT FOR WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, AND REFUNDS- Section 736 (21 U.S.C. 379h) is amended--

(1) by redesignating subsection (i) as subsection (j); and

(2) by inserting after subsection (h) the following: '(i) WRITTEN REQUESTS FOR WAIVERS, REDUCTIONS, AND REFUNDS- To qualify for consideration for a waiver or reduction under subsection (d), or for a refund of any fee collected in accordance with subsection (a), a person shall submit to the Secretary a written request for such waiver, reduction, or refund not later than 180 days after such fee is due.'

(h) SPECIAL RULE FOR WAIVERS AND REFUNDS- Any requests for waivers or refunds for fees assessed under section 736 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 379h) prior to the date of enactment of this Act shall be submitted in writing to the Secretary of Health and Human Services within 1 year after the date of enactment of this Act. Any requests for waivers or refunds pertaining to a fee for a human drug application or supplement accepted for filing prior to October 1, 1997 or to a product or establishment fee required by such Act for a fiscal year prior to fiscal year 1998, shall be evaluated according to the terms of the Prescription Drug User Fee Act of 1992 (as in effect on September 30, 1997) and part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (as in effect on September 30, 1997).

The term 'person' in such Acts shall continue to include an affiliate thereof.

(a) PERFORMANCE REPORT- Beginning with fiscal year 1998, not later than 60 days after the end of each fiscal year during which fees are collected under part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of Health and Human Services shall prepare and submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 101(4) during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals.

(b) FISCAL REPORT- Beginning with fiscal year 1998, not later than 120 days after the end of each fiscal year during which fees are collected under the part described in subsection (a), the Secretary of Health and Human Services shall prepare and submit to the Committee on Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected during such fiscal year for which the report is made.

Notwithstanding section 105 of the Prescription Drug User Fee Act of 1992, the Secretary shall retain the authority to assess and collect any fee required by part 2 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act for a human drug application or supplement accepted for filing prior to October 1, 1997, and to assess and collect any product or establishment fee required by such Act for a fiscal year prior to fiscal year 1998.

The amendments made by this subtitle shall take effect October 1, 1997.

The amendments made by sections 102 and 103 cease to be effective October 1, 2002, and section 104 ceases to be effective 120 days after such date.

SEC. 111. PEDIATRIC STUDIES OF DRUGS

Chapter V (21 U.S.C. 351 et seq.) is amended by inserting after section 505 the following:

'SEC. 505A. PEDIATRIC STUDIES OF DRUGS

'(a) MARKET EXCLUSIVITY FOR NEW DRUGS- If, prior to approval of an application that is submitted under section 505(b)(1), the Secretary determines that information relating to the use of a new drug in the pediatric population may produce health benefits in that population, the Secretary makes a written request for pediatric studies (which shall include a timeframe for completing such studies), and such studies are completed within any such timeframe and the reports thereof submitted in accordance with subsection (d)(2) or accepted in accordance with subsection (d)(3)--

'(1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of section 505, and in subsection (j)(4)(D)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of such section to four years, to forty-eight months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively; or

'(ii) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(D) of such section, and in clauses (iii) and (iv) of subsection (j)(4)(D) of such section, is deemed to be three years and six months rather than three years; and

'(B) if the drug is designated under section 526 for a rare disease or condition, the period referred to in section 527(a) is deemed to be seven years and six months rather than seven years; and

'(2)(A) if the drug is the subject of-- '(i) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 and for which pediatric studies were submitted prior to the expiration of the patent (including any patent extensions); or '(ii) a listed patent for which a certification has been submitted under subsections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(4)(B) shall be extended by a period of six months after the date the patent expires (including any patent extensions); or

'(B) if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(4)(B) shall be extended by a period of six months after the date the patent expires (including any patent extensions)

'(b) SECRETARY TO DEVELOP LIST OF DRUGS FOR WHICH ADDITIONAL PEDIATRIC INFORMATION MAY BE BENEFICIAL- Not later than 180 days after the date of enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary, after consultation with experts in pediatric research shall develop, prioritize, and publish an initial list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population. The Secretary shall annually update the list

'(c) MARKET EXCLUSIVITY FOR ALREADY-MARKETED DRUGS- If the Secretary makes a written request to the holder of an approved application under section 505(b)(1) for pediatric studies (which shall include a timeframe for completing such studies) concerning a drug identified in the list described in subsection (b), the holder agrees to the request, the studies are completed within any such timeframe, and the reports thereof are submitted in accordance with subsection (d)(2) or accepted in accordance with subsection (d)(3)--

'(1)(A)(i) the period referred to in subsection (c)(3)(D)(ii) of section 505, and in subsection (j)(4)(D)(ii) of such section, is deemed to be five years and six months rather than five years, and the references in subsections (c)(3)(D)(ii) and (j)(4)(D)(ii) of such section to four years, to forty-eight months, and to seven and one-half years are deemed to be four and one-half years, fifty-four months, and eight years, respectively; or

'(ii) the period referred to in clauses (iii) and (iv) of subsection (c)(3)(D) of such section, and in clauses (iii) and (iv) of subsection (j)(4)(D) of such section, is deemed to be three years and six months rather than three years; and

'(B) if the drug is designated under section 526 for a rare disease or condition, the period referred to in section 527(a) is deemed to be seven years and six months rather than seven years; and

'(2)(A) if the drug is the subject of-- '(i) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 and for which pediatric studies were submitted prior to the expiration of the patent (including any patent extensions); or '(ii) a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(4)(B) shall be extended by a period of six months after the date the patent expires (including any patent extensions); or

'(B) if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(4)(B) shall be extended by a period of six months after the date the patent expires (including any patent extensions)

'(d) CONDUCT OF PEDIATRIC STUDIES-

'(1) AGREEMENT FOR STUDIES- The Secretary may, pursuant to a written request from the Secretary under subsection (a) or (c), after consultation with-- '(A) the sponsor of an application for an investigational new drug under section 505(i); '(B) the sponsor of an application for a new drug under section 505(b)(1); or '(C) the holder of an approved application for a drug under section 505(b)(1), agree with the sponsor or holder for the conduct of pediatric studies for such drug. Such agreement shall be in writing and shall include a timeframe for such studies

'(2) WRITTEN PROTOCOLS TO MEET THE STUDIES REQUIREMENT- If the sponsor or holder and the Secretary agree upon written protocols for the studies, the studies requirement of subsection (a) or (c) is satisfied upon the completion of the studies and submission of the reports thereof in accordance with the original written request and the written agreement referred to in paragraph (1). Not later than 60 days after the submission of the report of the studies, the Secretary shall determine if such studies were or were not conducted in accordance with the original written request and the written agreement and reported in accordance with the requirements of the Secretary for filing and so notify the sponsor or holder

'(3) OTHER METHODS TO MEET THE STUDIES REQUIREMENT- If the sponsor or holder and the Secretary have not agreed in writing on the protocols for the studies, the studies requirement of subsection (a) or (c) is satisfied when such studies have been completed and the reports accepted by the Secretary. Not later than 90 days after the submission of the reports of the studies, the Secretary shall accept or reject such reports and so notify the sponsor or holder. The Secretary's only responsibility in accepting or rejecting the reports shall be to determine, within the 90 days, whether the studies fairly respond to the written request, have been conducted in accordance with commonly accepted scientific principles and protocols, and have been reported in accordance with the requirements of the Secretary for filing

'(e) DELAY OF EFFECTIVE DATE FOR CERTAIN APPLICATION- If the Secretary determines that the acceptance or approval of an application under section 505(b)(2) or 505(j) for a new drug may occur after submission of reports of pediatric studies under this section, which were submitted prior to the expiration of the patent (including any patent extension) or the applicable period under clauses (ii) through (iv) of section 505(c)(3)(D) or clauses (ii) through (iv) of section 505(j)(4)(D), but before the Secretary has determined whether the requirements of subsection (d) have been satisfied, the Secretary shall delay the acceptance or approval under section 505(b)(2) or 505(j) until the determination under subsection (d) is made, but any such delay shall not exceed 90 days. In the event that requirements of this section are satisfied, the applicable six-month period under subsection (a) or (c) shall be deemed to have been running during the period of delay

'(f) NOTICE OF DETERMINATIONS ON STUDIES REQUIREMENT- The Secretary shall publish a notice of any determination that the requirements of subsection (d) have been met and that submissions and approvals under subsection (b)(2) or (j) of section 505 for a drug will be subject to the provisions of this section

'(g) DEFINITIONS- As used in this section, the term 'pediatric studies' or 'studies' means at least one clinical investigation (that, at the Secretary's discretion, may include pharmacokinetic studies) in pediatric age groups in which a drug is anticipated to be used

'(h) LIMITATIONS- A drug to which the six-month period under subsection (a) or (b) has already been applied--

'(1) may receive an additional six-month period under subsection (c)(1)(A)(ii) for a supplemental application if all other requirements under this section are satisfied, except that such a drug may not receive any additional such period under subsection (c)(2); and

'(2) may not receive any additional such period under subsection (c)(1)(B)

'(i) RELATIONSHIP TO REGULATIONS- Notwithstanding any other provision of law, if any pediatric study is required pursuant to regulations promulgated by the Secretary and such study meets the completeness, timeliness, and other requirements of this section, such study shall be deemed to satisfy the requirement for market exclusivity pursuant to this section

'(j) SUNSET- A drug may not receive any six-month period under subsection (a) or (c) unless the application for the drug under section 505(b)(1) is submitted on or before January 1, 2002. After January 1, 2002, a drug shall receive a six-month period under subsection (c) if--

'(1) the drug was in commercial distribution as of the date of enactment of the Food and Drug Administration Modernization Act of 1997;

'(2) the drug was included by the Secretary on the list under subsection (b) as of January 1, 2002;

'(3) the Secretary determines that there is a continuing need for information relating to the use of the drug in the pediatric population and that the drug may provide health benefits in that population; and

'(4) all requirements of this section are met

'(k) REPORT- The Secretary shall conduct a study and report to Congress not later than January 1, 2001, based on the experience under the program established under this section. The study and report shall examine all relevant issues, including--

'(1) the effectiveness of the program in improving information about important pediatric uses for approved drugs;

'(2) the adequacy of the incentive provided under this section;

'(3) the economic impact of the program on taxpayers and consumers, including the impact of the lack of lower cost generic drugs on patients, including on lower income patients; and

'(4) any suggestions for modification that the Secretary determines to be appropriate.'

(a) IN GENERAL- Chapter V (21 U.S.C. 351 et seq.), as amended by section 125, is amended by inserting before section 508 the following:

'SEC. 506. FAST TRACK PRODUCTS

'(a) DESIGNATION OF DRUG AS A FAST TRACK PRODUCT-

'(1) IN GENERAL- The Secretary shall, at the request of the sponsor of a new drug, facilitate the development and expedite the review of such drug if it is intended for the treatment of a serious or life-threatening condition and it demonstrates the potential to address unmet medical needs for such a condition. (In this section, such a drug is referred to as a 'fast track product'.)

'(2) REQUEST FOR DESIGNATION- The sponsor of a new drug may request the Secretary to designate the drug as a fast track product. A request for the designation may be made concurrently with, or at any time after, submission of an application for the investigation of the drug under section 505(i) or section 351(a)(3) of the Public Health Service Act.

'(3) DESIGNATION- Within 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a fast track product and shall take such actions as are appropriate to expedite the development and review of the application for approval of such product.

'(b) APPROVAL OF APPLICATION FOR A FAST TRACK PRODUCT-

'(1) IN GENERAL- The Secretary may approve an application for approval of a fast track product under section 505(c) or section 351 of the Public Health Service Act upon a determination that the product has an effect on a clinical endpoint or on a surrogate endpoint that is reasonably likely to predict clinical benefit.

'(2) LIMITATION- Approval of a fast track product under this subsection may be subject to the requirements-- '(A) that the sponsor conduct appropriate post-approval studies to validate the surrogate endpoint or otherwise confirm the effect on the clinical endpoint; and '(B) that the sponsor submit copies of all promotional materials related to the fast track product during the preapproval review period and, following approval and for such period thereafter as the Secretary determines to be appropriate, at least 30 days prior to dissemination of the materials.

'(3) EXPEDITED WITHDRAWAL OF APPROVAL- The Secretary may withdraw approval of a fast track product using expedited procedures (as prescribed by the Secretary in regulations which shall include an opportunity for an informal hearing) if-- '(A) the sponsor fails to conduct any required post-approval study of the fast track drug with due diligence; '(B) a post-approval study of the fast track product fails to verify clinical benefit of the product; '(C) other evidence demonstrates that the fast track product is not safe or effective under the conditions of use; or '(D) the sponsor disseminates false or misleading promotional materials with respect to the product.

'(c) REVIEW OF INCOMPLETE APPLICATIONS FOR APPROVAL OF A FAST TRACK PRODUCT-

'(1) IN GENERAL- If the Secretary determines, after preliminary evaluation of clinical data submitted by the sponsor, that a fast track product may be effective, the Secretary shall evaluate for filing, and may commence review of portions of, an application for the approval of the product before the sponsor submits a complete application. The Secretary shall commence such review only if the applicant-- '(A) provides a schedule for submission of information necessary to make the application complete; and '(B) pays any fee that may be required under section 736.

'(2) EXCEPTION- Any time period for review of human drug applications that has been agreed to by the Secretary and that has been set forth in goals identified in letters of the Secretary (relating to the use of fees collected under section 736 to expedite the drug development process and the review of human drug applications) shall not apply to an application submitted under paragraph (1) until the date on which the application is complete.

'(d) AWARENESS EFFORTS- The Secretary shall--

'(1) develop and disseminate to physicians, patient organizations, pharmaceutical and biotechnology companies, and other appropriate persons a description of the provisions of this section applicable to fast track products; and

'(2) establish a program to encourage the development of surrogate endpoints that are reasonably likely to predict clinical benefit for serious or life-threatening conditions for which there exist significant unmet medical needs.'

(b) GUIDANCE- Within 1 year after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance for fast track products (as defined in section 506(a)(1) of the Federal Food, Drug, and Cosmetic Act) that describes the policies and procedures that pertain to section 506 of such Act.

(a) IN GENERAL- Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended--

(1) by redesignating subsections (j) and (k) as subsections (k) and (l), respectively; and

(2) by inserting after subsection (i) the following: '(j)(1)(A) The Secretary, acting through the Director of NIH, shall establish, maintain, and operate a data bank of information on clinical trials for drugs for serious or life-threatening diseases and conditions (in this subsection referred to as the 'data bank'). The activities of the data bank shall be integrated and coordinated with related activities of other agencies of the Department of Health and Human Services, and to the extent practicable, coordinated with other data banks containing similar information.

'(B) The Secretary shall establish the data bank after consultation with the Commissioner of Food and Drugs, the directors of the appropriate agencies of the National Institutes of Health (including the National Library of Medicine), and the Director of the Centers for Disease Control and Prevention.

'(2) In carrying out paragraph (1), the Secretary shall collect, catalog, store, and disseminate the information described in such paragraph. The Secretary shall disseminate such information through information systems, which shall include toll-free telephone communications, available to individuals with serious or life-threatening diseases and conditions, to other members of the public, to health care providers, and to researchers.

'(3) The data bank shall include the following:

'(A) A registry of clinical trials (whether federally or privately funded) of experimental treatments for serious or life-threatening diseases and conditions under regulations promulgated pursuant to section 505(i) of the Federal Food, Drug, and Cosmetic Act, which provides a description of the purpose of each experimental drug, either with the consent of the protocol sponsor, or when a trial to test effectiveness begins. Information provided shall consist of eligibility criteria for participation in the clinical trials, a description of the location of trial sites, and a point of contact for those wanting to enroll in the trial, and shall be in a form that can be readily understood by members of the public. Such information shall be forwarded to the data bank by the sponsor of the trial not later than 21 days after the approval of the protocol.

'(B) Information pertaining to experimental treatments for serious or life-threatening diseases and conditions that may be available-- '(i) under a treatment investigational new drug application that has been submitted to the Secretary under section 561(c) of the Federal Food, Drug, and Cosmetic Act; or '(ii) as a Group C cancer drug (as defined by the National Cancer Institute).

The data bank may also include information pertaining to the results of clinical trials of such treatments, with the consent of the sponsor, including information concerning potential toxicities or adverse effects associated with the use or administration of such experimental treatments.

'(4) The data bank shall not include information relating to an investigation if the sponsor has provided a detailed certification to the Secretary that disclosure of such information would substantially interfere with the timely enrollment of subjects in the investigation, unless the Secretary, after the receipt of the certification, provides the sponsor with a detailed written determination that such disclosure would not substantially interfere with such enrollment.

'(5) For the purpose of carrying out this subsection, there are authorized to be appropriated such sums as may be necessary. Fees collected under section 736 of the Federal Food, Drug, and Cosmetic Act shall not be used in carrying out this subsection.'

(b) COLLABORATION AND REPORT-

(1) IN GENERAL- The Secretary of Health and Human Services, the Director of the National Institutes of Health, and the Commissioner of Food and Drugs shall collaborate to determine the feasibility of including device investigations within the scope of the data bank under section 402(j) of the Public Health Service Act.

(2) REPORT- Not later than two years after the date of enactment of this section, the Secretary of Health and Human Services shall prepare and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Commerce of the House of Representatives a report-- (A) of the public health need, if any, for inclusion of device investigations within the scope of the data bank under section 402(j) of the Public Health Service Act; (B) on the adverse impact, if any, on device innovation and research in the United States if information relating to such device investigations is required to be publicly disclosed; and (C) on such other issues relating to such section 402(j) as the Secretary determines to be appropriate.

(a) IN GENERAL- Section 502(a) (21 U.S.C. 352(a)) is amended by adding at the end the following: 'Health care economic information provided to a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations, shall not be considered to be false or misleading under this paragraph if the health care economic information directly relates to an indication approved under section 505 or under section 351(a) of the Public Health Service Act for such drug and is based on competent and reliable scientific evidence. The requirements set forth in section 505(a) or in section 351(a) of the Public Health Service Act shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request. In this paragraph, the term 'health care economic information' means any analysis that identifies, measures, or compares the economic consequences, including the costs of the represented health outcomes, of the use of a drug to the use of another drug, to another health care intervention, or to no intervention.'

(b) STUDY AND REPORT- The Comptroller General of the United States shall conduct a study of the implementation of the provisions added by the amendment made by subsection (a). Not later than 4 years and 6 months after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit to Congress a report containing the findings of the study.

(a) CLARIFICATION OF THE NUMBER OF REQUIRED CLINICAL INVESTIGATIONS FOR APPROVAL- Section 505(d) (21 U.S.C. 355(d)) is amended by adding at the end the following: 'If the Secretary determines, based on relevant science, that data from one adequate and well-controlled clinical investigation and confirmatory evidence (obtained prior to or after such investigation) are sufficient to establish effectiveness, the Secretary may consider such data and evidence to constitute substantial evidence for purposes of the preceding sentence.'

(b) WOMEN AND MINORITIES- Section 505(b)(1) (21 U.S.C. 355(b)(1)) is amended by adding at the end the following: 'The Secretary shall, in consultation with the Director of the National Institutes of Health and with representatives of the drug manufacturing industry, review and develop guidance, as appropriate, on the inclusion of women and minorities in clinical trials required by clause (A).'

(a) IN GENERAL- Chapter V, as amended by section 112, is amended by inserting after section 506 the following section:

'SEC. 506A. MANUFACTURING CHANGES

'(a) IN GENERAL- With respect to a drug for which there is in effect an approved application under section 505 or 512 or a license under section 351 of the Public Health Service Act, a change from the manufacturing process approved pursuant to such application or license may be made, and the drug as made with the change may be distributed, if--

'(1) the holder of the approved application or license (referred to in this section as a 'holder') has validated the effects of the change in accordance with subsection (b); and

'(2)(A) in the case of a major manufacturing change, the holder has complied with the requirements of subsection (c); or

'(B) in the case of a change that is not a major manufacturing change, the holder complies with the applicable requirements of subsection (d).

'(b) VALIDATION OF EFFECTS OF CHANGES- For purposes of subsection (a)(1), a drug made with a manufacturing change (whether a major manufacturing change or otherwise) may be distributed only if, before distribution of the drug as so made, the holder involved validates the effects of the change on the identity, strength, quality, purity, and potency of the drug as the identity, strength, quality, purity, and potency may relate to the safety or effectiveness of the drug.

'(c) MAJOR MANUFACTURING CHANGES-

'(1) REQUIREMENT OF SUPPLEMENTAL APPLICATION- For purposes of subsection (a)(2)(A), a drug made with a major manufacturing change may be distributed only if, before the distribution of the drug as so made, the holder involved submits to the Secretary a supplemental application for such change and the Secretary approves the application. The application shall contain such information as the Secretary determines to be appropriate, and shall include the information developed under subsection (b) by the holder in validating the effects of the change.

'(2) CHANGES QUALIFYING AS MAJOR CHANGES- For purposes of subsection (a)(2)(A), a major manufacturing change is a manufacturing change that is determined by the Secretary to have substantial potential to adversely affect the identity, strength, quality, purity, or potency of the drug as they may relate to the safety or effectiveness of a drug. Such a change includes a change that-- '(A) is made in the qualitative or quantitative formulation of the drug involved or in the specifications in the approved application or license referred to in subsection (a) for the drug (unless exempted by the Secretary by regulation or guidance from the requirements of this subsection); '(B) is determined by the Secretary by regulation or guidance to require completion of an appropriate clinical study demonstrating equivalence of the drug to the drug as manufactured without the change; or '(C) is another type of change determined by the Secretary by regulation or guidance to have a substantial potential to adversely affect the safety or effectiveness of the drug.

'(d) OTHER MANUFACTURING CHANGES-

'(1) IN GENERAL- For purposes of subsection (a)(2)(B), the Secretary may regulate drugs made with manufacturing changes that are not major manufacturing changes as follows: '(A) The Secretary may in accordance with paragraph (2) authorize holders to distribute such drugs without submitting a supplemental application for such changes.

'(B) The Secretary may in accordance with paragraph (3) require that, prior to the distribution of such drugs, holders submit to the Secretary supplemental applications for such changes.

'(C) The Secretary may establish categories of such changes and designate categories to which subparagraph (A) applies and categories to which subparagraph (B) applies.

'(2) CHANGES NOT REQUIRING SUPPLEMENTAL APPLICATION- '(A) SUBMISSION OF REPORT- A holder making a manufacturing change to which paragraph (1)(A) applies shall submit to the Secretary a report on the change, which shall contain such information as the Secretary determines to be appropriate, and which shall include the information developed under subsection (b) by the holder in validating the effects of the change. The report shall be submitted by such date as the Secretary may specify.

'(B) AUTHORITY REGARDING ANNUAL REPORTS- In the case of a holder that during a single year makes more than one manufacturing change to which paragraph (1)(A) applies, the Secretary may in carrying out subparagraph (A) authorize the holder to comply with such subparagraph by submitting a single report for the year that provides the information required in such subparagraph for all the changes made by the holder during the year.

'(3) CHANGES REQUIRING SUPPLEMENTAL APPLICATION- '(A) SUBMISSION OF SUPPLEMENTAL APPLICATION- The supplemental application required under paragraph (1)(B) for a manufacturing change shall contain such information as the Secretary determines to be appropriate, which shall include the information developed under subsection (b) by the holder in validating the effects of the change.

'(B) AUTHORITY FOR DISTRIBUTION- In the case of a manufacturing change to which paragraph (1)(B) applies: '(i) The holder involved may commence distribution of the drug involved 30 days after the Secretary receives the supplemental application under such paragraph, unless the Secretary notifies the holder within such 30-day period that prior approval of the application is required before distribution may be commenced.

'(ii) The Secretary may designate a category of such changes for the purpose of providing that, in the case of a change that is in such category, the holder involved may commence distribution of the drug involved upon the receipt by the Secretary of a supplemental application for the change.

'(iii) If the Secretary disapproves the supplemental application, the Secretary may order the manufacturer to cease the distribution of the drugs that have been made with the manufacturing change.'

(b) TRANSITION RULE- The amendment made by subsection (a) takes effect upon the effective date of regulations promulgated by the Secretary of Health and Human Services to implement such amendment, or upon the expiration of the 24-month period beginning on the date of the enactment of this Act, whichever occurs first.

Section 505(i) (21 U.S.C. 355(i)) is amended--

(1) by redesignating paragraphs (1) through (3) as subparagraphs (A) through (C), respectively;

(2) by inserting '(1)' after '(i)';

(3) by striking the last two sentences; and

(4) by inserting after paragraph (1) (as designated by paragraph (2) of this section) the following new paragraphs: '(2) Subject to paragraph (3), a clinical investigation of a new drug may begin 30 days after the Secretary has received from the manufacturer or sponsor of the investigation a submission containing such information about the drug and the clinical investigation, including--

'(A) information on design of the investigation and adequate reports of basic information, certified by the applicant to be accurate reports, necessary to assess the safety of the drug for use in clinical investigation; and

'(B) adequate information on the chemistry and manufacturing of the drug, controls available for the drug, and primary data tabulations from animal or human studies.

'(3)(A) At any time, the Secretary may prohibit the sponsor of an investigation from conducting the investigation (referred to in this paragraph as a 'clinical hold') if the Secretary makes a determination described in subparagraph (B). The Secretary shall specify the basis for the clinical hold, including the specific information available to the Secretary which served as the basis for such clinical hold, and confirm such determination in writing.

'(B) For purposes of subparagraph (A), a determination described in this subparagraph with respect to a clinical hold is that--

'(i) the drug involved represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation, taking into account the qualifications of the clinical investigators, information about the drug, the design of the clinical investigation, the condition for which the drug is to be investigated, and the health status of the subjects involved; or

'(ii) the clinical hold should be issued for such other reasons as the Secretary may by regulation establish (including reasons established by regulation before the date of the enactment of the Food and Drug Administration Modernization Act of 1997).

'(C) Any written request to the Secretary from the sponsor of an investigation that a clinical hold be removed shall receive a decision, in writing and specifying the reasons therefor, within 30 days after receipt of such request. Any such request shall include sufficient information to support the removal of such clinical hold.

'(4) Regulations under paragraph (1) shall provide that such exemption shall be conditioned upon the manufacturer, or the sponsor of the investigation, requiring that experts using such drugs for investigational purposes certify to such manufacturer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where it is not feasible or it is contrary to the best interests of such human beings. Nothing in this subsection shall be construed to require any clinical investigator to submit directly to the Secretary reports on the investigational use of drugs.'

Within 12 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue guidance that describes when abbreviated study reports may be submitted, in lieu of full reports, with a new drug application under section 505(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) and with a biologics license application under section 351 of the Public Health Service Act (42 U.S.C. 262) for certain types of studies. Such guidance shall describe the kinds of studies for which abbreviated reports are appropriate and the appropriate abbreviated report formats.

(a) SECTION 505(b)- Section 505(b) (21 U.S.C. 355(b)) is amended by adding at the end the following: '(4)(A) The Secretary shall issue guidance for the individuals who review applications submitted under paragraph (1) or under section 351 of the Public Health Service Act, which shall relate to promptness in conducting the review, technical excellence, lack of bias and conflict of interest, and knowledge of regulatory and scientific standards, and which shall apply equally to all individuals who review such applications.

'(B) The Secretary shall meet with a sponsor of an investigation or an applicant for approval for a drug under this subsection or section 351 of the Public Health Service Act if the sponsor or applicant makes a reasonable written request for a meeting for the purpose of reaching agreement on the design and size of clinical trials intended to form the primary basis of an effectiveness claim. The sponsor or applicant shall provide information necessary for discussion and agreement on the design and size of the clinical trials. Minutes of any such meeting shall be prepared by the Secretary and made available to the sponsor or applicant upon request.

'(C) Any agreement regarding the parameters of the design and size of clinical trials of a new drug under this paragraph that is reached between the Secretary and a sponsor or applicant shall be reduced to writing and made part of the administrative record by the Secretary. Such agreement shall not be changed after the testing begins, except--

'(i) with the written agreement of the sponsor or applicant; or

'(ii) pursuant to a decision, made in accordance with subparagraph (D) by the director of the reviewing division, that a substantial scientific issue essential to determining the safety or effectiveness of the drug has been identified after the testing has begun.

'(D) A decision under subparagraph (C)(ii) by the director shall be in writing and the Secretary shall provide to the sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant will be present and at which the director will document the scientific issue involved.

'(E) The written decisions of the reviewing division shall be binding upon, and may not directly or indirectly be changed by, the field or compliance division personnel unless such field or compliance division personnel demonstrate to the reviewing division why such decision should be modified.

'(F) No action by the reviewing division may be delayed because of the unavailability of information from or action by field personnel unless the reviewing division determines that a delay is necessary to assure the marketing of a safe and effective drug.

'(G) For purposes of this paragraph, the reviewing division is the division responsible for the review of an application for approval of a drug under this subsection or section 351 of the Public Health Service Act (including all scientific and medical matters, chemistry, manufacturing, and controls).'

(b) SECTION 505(j)-

(1) AMENDMENT- Section 505(j) (21 U.S.C 355(j)) is amended-- (A) by redesignating paragraphs (3) through (8) as paragraphs (4) through (9), respectively; and (B) by adding after paragraph (2) the following: '(3)(A) The Secretary shall issue guidance for the individuals who review applications submitted under paragraph (1), which shall relate to promptness in conducting the review, technical excellence, lack of bias and conflict of interest, and knowledge of regulatory and scientific standards, and which shall apply equally to all individuals who review such applications.

'(B) The Secretary shall meet with a sponsor of an investigation or an applicant for approval for a drug under this subsection if the sponsor or applicant makes a reasonable written request for a meeting for the purpose of reaching agreement on the design and size of bioavailability and bioequivalence studies needed for approval of such application. The sponsor or applicant shall provide information necessary for discussion and agreement on the design and size of such studies. Minutes of any such meeting shall be prepared by the Secretary and made available to the sponsor or applicant.

'(C) Any agreement regarding the parameters of design and size of bioavailability and bioequivalence studies of a drug under this paragraph that is reached between the Secretary and a sponsor or applicant shall be reduced to writing and made part of the administrative record by the Secretary. Such agreement shall not be changed after the testing begins, except--

'(i) with the written agreement of the sponsor or applicant; or

'(ii) pursuant to a decision, made in accordance with subparagraph (D) by the director of the reviewing division, that a substantial scientific issue essential to determining the safety or effectiveness of the drug has been identified after the testing has begun.

'(D) A decision under subparagraph (C)(ii) by the director shall be in writing and the Secretary shall provide to the sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant will be present and at which the director will document the scientific issue involved.

'(E) The written decisions of the reviewing division shall be binding upon, and may not directly or indirectly be changed by, the field or compliance office personnel unless such field or compliance office personnel demonstrate to the reviewing division why such decision should be modified..

'(F) No action by the reviewing division may be delayed because of the unavailability of information from or action by field personnel unless the reviewing division determines that a delay is necessary to assure the marketing of a safe and effective drug.

'(G) For purposes of this paragraph, the reviewing division is the division responsible for the review of an application for approval of a drug under this subsection (including scientific matters, chemistry, manufacturing, and controls).'

(2) CONFORMING AMENDMENTS- Section 505(j) (21 U.S.C. 355(j)), as amended by paragraph (1), is further amended-- (A) in paragraph (2)(A)(i), by striking '(6)' and inserting '(7)'; (B) in paragraph (4) (as redesignated in paragraph (1)), by striking '(4)' and inserting '(5)'; (C) in paragraph (4)(I) (as redesignated in paragraph (1)), by striking '(5)' and inserting '(6)'; and (D) in paragraph (7)(C) (as redesignated in paragraph (1)), by striking '(5)' each place it occurs and inserting '(6)'.

Section 505 (21 U.S.C. 355) is amended by adding at the end the following: '(n)(1) For the purpose of providing expert scientific advice and recommendations to the Secretary regarding a clinical investigation of a drug or the approval for marketing of a drug under section 505 or section 351 of the Public Health Service Act, the Secretary shall establish panels of experts or use panels of experts established before the date of enactment of the Food and Drug Administration Modernization Act of 1997, or both.

'(2) The Secretary may delegate the appointment and oversight authority granted under section 904 to a director of a center or successor entity within the Food and Drug Administration.

'(3) The Secretary shall make appointments to each panel established under paragraph (1) so that each panel shall consist of--

'(A) members who are qualified by training and experience to evaluate the safety and effectiveness of the drugs to be referred to the panel and who, to the extent feasible, possess skill and experience in the development, manufacture, or utilization of such drugs;

'(B) members with diverse expertise in such fields as clinical and administrative medicine, pharmacy, pharmacology, pharmacoeconomics, biological and physical sciences, and other related professions;

'(C) a representative of consumer interests, and a representative of interests of the drug manufacturing industry not directly affected by the matter to be brought before the panel; and

'(D) two or more members who are specialists or have other expertise in the particular disease or condition for which the drug under review is proposed to be indicated.

Scientific, trade, and consumer organizations shall be afforded an opportunity to nominate individuals for appointment to the panels.

No individual who is in the regular full-time employ of the United States and engaged in the administration of this Act may be a voting member of any panel. The Secretary shall designate one of the members of each panel to serve as chairman thereof.

'(4) Each member of a panel shall publicly disclose all conflicts of interest that member may have with the work to be undertaken by the panel. No member of a panel may vote on any matter where the member or the immediate family of such member could gain financially from the advice given to the Secretary. The Secretary may grant a waiver of any conflict of interest requirement upon public disclosure of such conflict of interest if such waiver is necessary to afford the panel essential expertise, except that the Secretary may not grant a waiver for a member of a panel when the member's own scientific work is involved.

'(5) The Secretary shall, as appropriate, provide education and training to each new panel member before such member participates in a panel's activities, including education regarding requirements under this Act and related regulations of the Secretary, and the administrative processes and procedures related to panel meetings.

'(6) Panel members (other than officers or employees of the United States), while attending meetings or conferences of a panel or otherwise engaged in its business, shall be entitled to receive compensation for each day so engaged, including traveltime, at rates to be fixed by the Secretary, but not to exceed the daily equivalent of the rate in effect for positions classified above grade GS-15 of the General Schedule. While serving away from their homes or regular places of business, panel members may be allowed travel expenses (including per diem in lieu of subsistence) as authorized by section 5703 of title 5, United States Code, for persons in the Government service employed intermittently.

'(7) The Secretary shall ensure that scientific advisory panels meet regularly and at appropriate intervals so that any matter to be reviewed by such a panel can be presented to the panel not more than 60 days after the matter is ready for such review. Meetings of the panel may be held using electronic communication to convene the meetings.

'(8) Within 90 days after a scientific advisory panel makes recommendations on any matter under its review, the Food and Drug Administration official responsible for the matter shall review the conclusions and recommendations of the panel, and notify the affected persons of the final decision on the matter, or of the reasons that no such decision has been reached. Each such final decision shall be documented including the rationale for the decision.'

SEC. 121. POSITRON EMISSION TOMOGRAPHY

(a) REGULATION OF COMPOUNDED POSITRON EMISSION TOMOGRAPHY DRUGS- Section 201 (21 U.S.C. 321) is amended by adding at the end the following: '(ii) The term 'compounded positron emission tomography drug'--

'(1) means a drug that-- '(A) exhibits spontaneous disintegration of unstable nuclei by the emission of positrons and is used for the purpose of providing dual photon positron emission tomographic diagnostic images; and '(B) has been compounded by or on the order of a practitioner who is licensed by a State to compound or order compounding for a drug described in subparagraph (A), and is compounded in accordance with that State's law, for a patient or for research, teaching, or quality control; and

'(2) includes any nonradioactive reagent, reagent kit, ingredient, nuclide generator, accelerator, target material, electronic synthesizer, or other apparatus or computer program to be used in the preparation of such a drug.'

(b) ADULTERATION-

(1) IN GENERAL- Section 501(a) (21 U.S.C. 351(a)) is amended by striking '; or (3)' and inserting the following: '; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or (3)'

(2) SUNSET- Section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not apply 4 years after the date of enactment of this Act or 2 years after the date on which the Secretary of Health and Human Services establishes the requirements described in subsection (c)(1)(B), whichever is later.

(c) REQUIREMENTS FOR REVIEW OF APPROVAL PROCEDURES AND CURRENT GOOD MANUFACTURING PRACTICES FOR POSITRON EMISSION TOMOGRAPHY-

(1) PROCEDURES AND REQUIREMENTS- (A) IN GENERAL- In order to take account of the special characteristics of positron emission tomography drugs and the special techniques and processes required to produce these drugs, not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall establish-- (i) appropriate procedures for the approval of positron emission tomography drugs pursuant to section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355); and (ii) appropriate current good manufacturing practice requirements for such drugs.

(B) CONSIDERATIONS AND CONSULTATION- In establishing the procedures and requirements required by subparagraph (A), the Secretary of Health and Human Services shall take due account of any relevant differences between not-for-profit institutions that compound the drugs for their patients and commercial manufacturers of the drugs. Prior to establishing the procedures and requirements, the Secretary of Health and Human Services shall consult with patient advocacy groups, professional associations, manufacturers, and physicians and scientists licensed to make or use positron emission tomography drugs.

(2) SUBMISSION OF NEW DRUG APPLICATIONS AND ABBREVIATED NEW DRUG APPLICATIONS- (A) IN GENERAL- Except as provided in subparagraph (B), the Secretary of Health and Human Services shall not require the submission of new drug applications or abbreviated new drug applications under subsection (b) or (j) of section 505 (21 U.S.C. 355), for compounded positron emission tomography drugs that are not adulterated drugs described in section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) (as amended by subsection (b)), for a period of 4 years after the date of enactment of this Act, or for 2 years after the date on which the Secretary establishes procedures and requirements under paragraph (1), whichever is longer.

(B) EXCEPTION- Nothing in this Act shall prohibit the voluntary submission of such applications or the review of such applications by the Secretary of Health and Human Services. Nothing in this Act shall constitute an exemption for a positron emission tomography drug from the requirements of regulations issued under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)).

(d) REVOCATION OF CERTAIN INCONSISTENT DOCUMENTS- Within 30 days after the date of enactment of this Act, the Secretary of Health and Human Services shall publish in the Federal Register a notice terminating the application of the following notices and rule:

(1) A notice entitled 'Regulation of Positron Emission Tomography Radiopharmaceutical Drug Products; Guidance; Public Workshop', published in the Federal Register on February 27, 1995, 60 Fed. Reg. 10594

(2) A notice entitled 'Draft Guideline on the Manufacture of Positron Emission Tomography Radiopharmaceutical Drug Products; Availability', published in the Federal Register on February 27, 1995, 60 Fed. Reg. 10593.

(3) A final rule entitled 'Current Good Manufacturing Practice for Finished Pharmaceuticals; Positron Emission Tomography', published in the Federal Register on April 22, 1997, 62 Fed. Reg. 19493 (codified at part 211 of title 21, Code of Federal Regulations).

(e) DEFINITION- As used in this section, the term 'compounded positron emission tomography drug' has the meaning given the term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).

(a) REQUIREMENTS-

(1) REGULATIONS- (A) PROPOSED REGULATIONS- Not later than 180 days after the date of enactment of this Act, the Secretary of Health and Human Services, after consultation with patient advocacy groups, associations, physicians licensed to use radiopharmaceuticals, and the regulated industry, shall issue proposed regulations governing the approval of radiopharmaceuticals. The regulations shall provide that the determination of the safety and effectiveness of such a radiopharmaceutical under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262) shall include consideration of the proposed use of the radiopharmaceutical in the practice of medicine, the pharmacological and toxicological activity of the radiopharmaceutical (including any carrier or ligand component of the radiopharmaceutical), and the estimated absorbed radiation dose of the radiopharmaceutical.

(B) FINAL REGULATIONS- Not later than 18 months after the date of enactment of this Act, the Secretary shall promulgate final regulations governing the approval of the radiopharmaceuticals.

(2) SPECIAL RULE- In the case of a radiopharmaceutical, the indications for which such radiopharmaceutical is approved for marketing may, in appropriate cases, refer to manifestations of disease (such as biochemical, physiological, anatomic, or pathological processes) common to, or present in, one or more disease states.

(b) DEFINITION- In this section, the term 'radiopharma-ceutical' means--

(1) an article-- (A) that is intended for use in the diagnosis or monitoring of a disease or a manifestation of a disease in humans; and (B) that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons; or

(2) any nonradioactive reagent kit or nuclide generator that is intended to be used in the preparation of any such article.

(a) LICENSES-

(1) IN GENERAL- Section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) is amended to read as follows: '(a)(1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless--

'(A) a biologics license is in effect for the biological product; and

'(B) each package of the biological product is plainly marked with-- '(i) the proper name of the biological product contained in the package; '(ii) the name, address, and applicable license number of the manufacturer of the biological product; and '(iii) the expiration date of the biological product..

'(2)(A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses.

'(B) The Secretary shall approve a biologics license application--

'(i) on the basis of a demonstration that-- '(I) the biological product that is the subject of the application is safe, pure, and potent; and '(II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and

'(ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c).

'(3) The Secretary shall prescribe requirements under which a biological product undergoing investigation shall be exempt from the requirements of paragraph (1).'

(2) ELIMINATION OF EXISTING LICENSE REQUIREMENT- Section 351(d) of the Public Health Service Act (42 U.S.C. 262(d)) is amended-- (A) by striking '(d)(1)' and all that follows through 'of this section.'; (B) in paragraph (2)-- (i) by striking '(2)(A) Upon' and inserting '(d)(1) Upon' and (ii) by redesignating subparagraph (B) as paragraph (2); and (C) in paragraph (2) (as so redesignated by subparagraph (B)(ii))-- (i) by striking 'subparagraph (A)' and inserting 'paragraph (1)'; and (ii) by striking 'this subparagraph' each place it appears and inserting 'this paragraph'.`

(b) LABELING- Section 351(b) of the Public Health Service Act (42 U.S.C. 262(b)) is amended to read as follows: '(b) No person shall falsely label or mark any package or container of any biological product or alter any label or mark on the package or container of the biological product so as to falsify the label or mark.'

(c) INSPECTION- Section 351(c) of the Public Health Service Act (42 U.S.C. 262(c)) is amended by striking 'virus, serum,' and all that follows and inserting 'biological product.'

(d) DEFINITION; APPLICATION- Section 351 of the Public Health Service Act (42 U.S.C. 262) is amended by adding at the end the following: '(i) In this section, the term 'biological product' means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.'

(e) CONFORMING AMENDMENT- Section 503(g)(4) (21 U.S.C. 353(g)(4)) is amended--

(1) in subparagraph (A)-- (A) by striking 'section 351(a)' and inserting 'section 351(i)'; and (B) by striking '262(a)' and inserting '262(i)'; and

(2) in subparagraph (B)(iii), by striking 'product or establishment license under subsection (a) or (d)' and inserting 'biologics license application under subsection (a)'.

(f) SPECIAL RULE- The Secretary of Health and Human Services shall take measures to minimize differences in the review and approval of products required to have approved biologics license applications under section 351 of the Public Health Service Act (42 U.S.C. 262) and products required to have approved new drug applications under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)).

(g) APPLICATION OF FEDERAL FOOD, DRUG, AND COSMETIC ACT- Section 351 of the Public Health Service Act (42 U.S.C. 262), as amended by subsection (d), is further amended by adding at the end the following: '(j) The Federal Food, Drug, and Cosmetic Act applies to a biological product subject to regulation under this section, except that a product for which a license has been approved under subsection (a) shall not be required to have an approved application under section 505 of such Act.'

(h) EXAMINATIONS AND PROCEDURES- Paragraph (3) of section 353(d) of the Public Health Service Act (42 U.S.C. 263a(d)) is amended to read as follows:

'(3) EXAMINATIONS AND PROCEDURES- The examinations and procedures identified in paragraph (2) are laboratory examinations and procedures that have been approved by the Food and Drug Administration for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that-- '(A) employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or '(B) the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly.'

(a) HUMAN DRUGS- Section 505(c) (21 U.S.C. 355(c)) is amended by adding at the end the following: '(4) A drug manufactured in a pilot or other small facility may be used to demonstrate the safety and effectiveness of the drug and to obtain approval for the drug prior to manufacture of the drug in a larger facility, unless the Secretary makes a determination that a full scale production facility is necessary to ensure the safety or effectiveness of the drug.'

(b) ANIMAL DRUGS- Section 512(c) (21 U.S.C. 360b(c)) is amended by adding at the end the following: '(4) A drug manufactured in a pilot or other small facility may be used to demonstrate the safety and effectiveness of the drug and to obtain approval for the drug prior to manufacture of the drug in a larger facility, unless the Secretary makes a determination that a full scale production facility is necessary to ensure the safety or effectiveness of the drug.'

(a) CERTIFICATION OF DRUGS CONTAINING INSULIN-

(1) AMENDMENT- Section 506 (21 U.S.C. 356), as in effect before the date of the enactment of this Act, is repealed.

(2) Conforming amendments- (A) Section 301(j) (21 U.S.C. 331(j)) is amended by striking '506, 507,'.

(B) Subsection (k) of section 502 (21 U.S.C. 352) is repealed.

(C) Sections 301(i)(1), 510(j)(1)(A), and 510(j)(1)(D) (21 U.S.C. 331(i)(1), 360(j)(1)(A), 360(j)(1)(D)) are each amended by striking ', 506, 507,'.

(D) Section 801(d)(1) (21 U.S.C. 381(d)(1)) is amended by inserting after '503(b)' the following: 'or composed wholly or partly of insulin'.

(E) Section 8126(h)(2) of title 38, United States Code, is amended by inserting 'or' at the end of subparagraph (B), by striking '; or' at the end of subparagraph (C) and inserting a period, and by striking subparagraph (D).

(b) CERTIFICATION OF ANTIBIOTICS-

(1) AMENDMENT- Section 507 (21 U.S.C. 357) is repealed.

(2) Conforming amendments- (A) Section 201(aa) (21 U.S.C. 321(aa)) is amended by striking out 'or 507', section 201(dd) (21 U.S.C. 321(dd)) is amended by striking '507,', and section 201(ff)(3)(A) (21 U.S.C. 321(ff)(3)(A)) is amended by striking ', certified as an antibiotic under section 507,'.

(B) Section 301(e) (21 U.S.C. 331(e)) is amended by striking '507(d) or (g),'.

(C) Section 306(d)(4)(B)(ii) (21 U.S.C. 335a(d)(4)(B)(ii)) is amended by striking 'or 507'.

(D) Section 502 (21 U.S.C. 352) is amended by striking subsection (l).

(E) Section 520(l) (21 U.S.C. 360j(l)) is amended by striking paragraph (4) and by striking 'or Antibiotic Drugs' in the subsection heading.

(F) Section 525(a) (21 U.S.C. 360aa(a)) is amended by inserting 'or' at the end of paragraph (1), by striking paragraph (2), and by redesignating paragraph (3) as paragraph (2).

(G) Section 525(a) (21 U.S.C. 360aa(a)) is amended by striking ', certification of such drug for such disease or condition under section 507,'.

(H) Section 526(a)(1) (21 U.S.C. 360bb) is amended by striking 'the submission of an application for certification of the drug under section 507,', by inserting 'or' at the end of subparagraph (A), by striking subparagraph (B), and by redesignating subparagraph (C) as subparagraph (B).

(I) Section 526(b) (21 U.S.C. 360bb(b)) is amended-- (i) in paragraph (1), by striking ', a certificate was issued for the drug under section 507,'; and (ii) in paragraph (2) by striking ', a certificate has not been issued for the drug under section 507,' and by striking ', approval of an application for certification under section 507,'.

(J) Section 527(a) (21 U.S.C. 360cc(a)) is amended by inserting 'or' at the end of paragraph (1), by striking paragraph (2), by redesignating paragraph (3) as paragraph (2), and by striking ', issue another certification under section 507,'.

(K) Section 527(b) (21 U.S.C. 360cc(b)) is amended by striking ', if a certification is issued under section 507 for such a drug,', ', of the issuance of the certification under section 507,', ', issue another certification under section 507,', ', of such certification,', ', of the certification,', and ', issuance of other certifications,'.

(L) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended by striking ', section 507 (d) or (g),'.

(M) Section 735(1) (21 U.S.C. 379g(1)(C)) is amended by inserting 'or' at the end of subparagraph (B), by striking subparagraph (C), and by redesignating subparagraph (D) as subparagraph (C).

(N) Subparagraphs (A)(ii) and (B) of sections 5(b)(1) of the Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A), 360ee(b)(1)(B)) are each amended by striking 'or 507'.

(O) Section 45C(b)(2)(A)(ii)(II) of the Internal Revenue Code of 1986 is amended by striking 'or 507'.

(P) Section 156(f)(4)(B) of title 35, United States Code, is amended by striking '507,' each place it occurs.

(c) EXPORTATION- Section 802 (21 U.S.C. 382) is amended by adding at the end the following: '(i) Insulin and antibiotic drugs may be exported without regard to the requirements in this section if the insulin and antibiotic drugs meet the requirements of section 801(e)(1).'

(d) TRANSITION-

(1) IN GENERAL- An application that was approved by the Secretary of Health and Human Services before the date of the enactment of this Act for the marketing of an antibiotic drug under section 507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357), as in effect on the day before the date of the enactment of this Act, shall, on and after such date of enactment, be considered to be an application that was submitted and filed under section 505(b) of such Act (21 U.S.C. 355(b)) and approved for safety and effectiveness under section 505(c) of such Act (21 U.S.C. 355(c)), except that if such application for marketing was in the form of an abbreviated application, the application shall be considered to have been filed and approved under section 505(j) of such Act (21 U.S.C 355(j)).

(2) EXCEPTION- The following subsections of section 505 (21 U.S.C. 355) shall not apply to any application for marketing in which the drug that is the subject of the application contains an antibiotic drug and the antibiotic drug was the subject of any application for marketing received by the Secretary of Health and Human Services under section 507 of such Act (21 U.S.C. 357) before the date of the enactment of this Act: (A)(i) Subsections (c)(2), (d)(6), (e)(4), (j)(2)(A)(vii), (j)(2)(A)(viii), (j)(2)(B), (j)(4)(B), and (j)(4)(D); and (ii) The third and fourth sentences of subsection (b)(1) (regarding the filing and publication of patent information); and (B) Subsections (b)(2)(A), (b)(2)(B), (b)(3), and (c)(3) if the investigations relied upon by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted.

(3) PUBLICATION- For purposes of this section, the Secretary is authorized to make available to the public the established name of each antibiotic drug that was the subject of any application for marketing received by the Secretary for Health and Human Services under section 507 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 357) before the date of enactment of this Act.

(e) DEFINITION- Section 201 (21 U.S.C. 321), as amended by section 121(a)(1), is further amended by adding at the end the following: '(jj) The term 'antibiotic drug' means any drug (except drugs for use in animals other than humans) composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other drug intended for human use containing any quantity of any chemical substance which is produced by a micro-organism and which has the capacity to inhibit or destroy micro-organisms in dilute solution (including a chemically synthesized equivalent of any such substance) or any derivative thereof.'

(a) PRESCRIPTION DRUGS- Section 503(b)(4) (21 U.S.C. 353(b)(4)) is amended to read as follows: '(4)(A) A drug that is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to dispensing the label of the drug fails to bear, at a minimum, the symbol 'Rx only'.

'(B) A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing the label of the drug bears the symbol described in subparagraph (A).'

(b) MISBRANDED DRUG- Section 502(d) (21 U.S.C. 352(d)) is repealed.

(c) CONFORMING AMENDMENTS-

(1) Section 503(b)(1) (21 U.S.C. 353(b)(1)) is amended-- (A) by striking subparagraph (A); and (B) by redesignating subparagraphs (B) and (C) as subparagraphs (A) and (B), respectively.

(2) Section 503(b)(3) (21 U.S.C. 353(b)(3)) is amended by striking 'section 502(d) and'.

(3) Section 102(9)(A) of the Controlled Substances Act (21 U.S.C. 802(9)(A)) is amended-- (A) in clause (i), by striking '(i)'; and (B) by striking '(ii)' and all that follows.

(a) AMENDMENT- Chapter V is amended by inserting after section 503 (21 U.S.C. 353) the following:

'SEC. 503A. PHARMACY COMPOUNDING

'(a) IN GENERAL- Sections 501(a)(2)(B), 502(f)(1), and 505 shall not apply to a drug product if the drug product is compounded for an identified individual patient based on the unsolicited receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient, if the drug product meets the requirements of this section, and if the compounding--

'(1) is by-- '(A) a licensed pharmacist in a State licensed pharmacy or a Federal facility, or '(B) a licensed physician, on the prescription order for such individual patient made by a licensed physician or other licensed practitioner authorized by State law to prescribe drugs; or

'(2)(A) is by a licensed pharmacist or licensed physician in limited quantities before the receipt of a valid prescription order for such individual patient; and

'(B) is based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship between-- '(i) the licensed pharmacist or licensed physician; and '(ii)(I) such individual patient for whom the prescription order will be provided; or '(II) the physician or other licensed practitioner who will write such prescription order.

'(b) COMPOUNDED DRUG-

'(1) LICENSED PHARMACIST AND LICENSED PHYSICIAN- A drug product may be compounded under subsection (a) if the licensed pharmacist or licensed physician-- '(A) compounds the drug product using bulk drug substances, as defined in regulations of the Secretary published at section 207.3(a)(4) of title 21 of the Code of Federal Regulations-- '(i) that-- '(I) comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding; '(II) if such a monograph does not exist, are drug substances that are components of drugs approved by the Secretary; or '(III) if such a monograph does not exist and the drug substance is not a component of a drug approved by the Secretary, that appear on a list developed by the Secretary through regulations issued by the Secretary under subsection (d); '(ii) that are manufactured by an establishment that is registered under section 510 (including a foreign establishment that is registered under section 510(i)); and '(iii) that are accompanied by valid certificates of analysis for each bulk drug substance; '(B) compounds the drug product using ingredients (other than bulk drug substances) that comply with the standards of an applicable United States Pharmacopoeia or National Formulary monograph, if a monograph exists, and the United States Pharmacopoeia chapter on pharmacy compounding; '(C) does not compound a drug product that appears on a list published by the Secretary in the Federal Register of drug products that have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective; and '(D) does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available drug product.

'(2) DEFINITION- For purposes of paragraph (1)(D), the term 'essentially a copy of a commercially available drug product' does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product.

'(3) DRUG PRODUCT- A drug product may be compounded under subsection (a) only if-- '(A) such drug product is not a drug product identified by the Secretary by regulation as a drug product that presents demonstrable difficulties for compounding that reasonably demonstrate an adverse effect on the safety or effectiveness of that drug product; and '(B) such drug product is compounded in a State-- '(i) that has entered into a memorandum of understanding with the Secretary which addresses the distribution of inordinate amounts of compounded drug products interstate and provides for appropriate investigation by a State agency of complaints relating to compounded drug products distributed outside such State; or '(ii) that has not entered into the memorandum of understanding described in clause (i) and the licensed pharmacist, licensed pharmacy, or licensed physician distributes (or causes to be distributed) compounded drug products out of the State in which they are compounded in quantities that do not exceed 5 percent of the total prescription orders dispensed or distributed by such pharmacy or physician.

The Secretary shall, in consultation with the National Association of Boards of Pharmacy, develop a standard memorandum of understanding for use by the States in complying with subparagraph (B)(i).

'(c) ADVERTISING AND PROMOTION- A drug may be compounded under subsection (a) only if the pharmacy, licensed pharmacist, or licensed physician does not advertise or promote the compounding of any particular drug, class of drug, or type of drug. The pharmacy, licensed pharmacist, or licensed physician may advertise and promote the compounding service provided by the licensed pharmacist or licensed physician.

'(d) REGULATIONS-

'(1) IN GENERAL- The Secretary shall issue regulations to implement this section. Before issuing regulations to implement subsections (b)(1)(A)(i)(III), (b)(1)(C), or (b)(3)(A), the Secretary shall convene and consult an advisory committee on compounding unless the Secretary determines that the issuance of such regulations before consultation is necessary to protect the public health. The advisory committee shall include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopoeia, pharmacy, physician, and consumer organizations, and other experts selected by the Secretary.

'(2) LIMITING COMPOUNDING- The Secretary, in consultation with the United States Pharmacopoeia Convention, Incorporated, shall promulgate regulations identifying drug substances that may be used in compounding under subsection (b)(1)(A)(i)(III) for which a monograph does not exist or which are not components of drug products approved by the Secretary. The Secretary shall include in the regulation the criteria for such substances, which shall include historical use, reports in peer reviewed medical literature, or other criteria the Secretary may identify.

'(e) APPLICATION- This section shall not apply to--

'(1) compounded positron emission tomography drugs as defined in section 201(ii); or

'(2) radiopharmaceuticals.

'(f) DEFINITION- As used in this section, the term 'compounding' does not include mixing, reconstituting, or other such acts that are performed in accordance with directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with that labeling.'

(b) EFFECTIVE DATE- Section 503A of the Federal Food, Drug, and Cosmetic Act, added by subsection (a), shall take effect upon the expiration of the 1-year period beginning on the date of the enactment of this Act.

Section 2 of Public Law 102-222 (105 Stat. 1677) is amended--

(1) in subsection (a), by striking 'a grant' and all that follows through 'Such grant' and inserting the following: 'grants for a pilot program for the training of individuals in clinical pharmacology at appropriate medical schools. Such grants'; and

(2) in subsection (b), by striking 'to carry out this section' and inserting ', and for fiscal years 1998 through 2002 $3,000,000 for each fiscal year, to carry out this section'.

Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue regulations for over-the-counter sunscreen products for the prevention or treatment of sunburn.

(a) IN GENERAL- Chapter V, as amended by section 116, is further amended by inserting after section 506A the following:

'SEC. 506B. REPORTS OF POSTMARKETING STUDIES

'(a) SUBMISSION-

'(1) IN GENERAL- A sponsor of a drug that has entered into an agreement with the Secretary to conduct a postmarketing study of a drug shall submit to the Secretary, within 1 year after the approval of such drug and annually thereafter until the study is completed or terminated, a report of the progress of the study or the reasons for the failure of the sponsor to conduct the study. The report shall be submitted in such form as is prescribed by the Secretary in regulations issued by the Secretary

'(2) AGREEMENTS PRIOR TO EFFECTIVE DATE- Any agreement entered into between the Secretary and a sponsor of a drug, prior to the date of enactment of the Food and Drug Administration Modernization Act of 1997, to conduct a postmarketing study of a drug shall be subject to the requirements of paragraph (1). An initial report for such an agreement shall be submitted within 6 months after the date of the issuance of the regulations under paragraph (1).

'(b) CONSIDERATION OF INFORMATION AS PUBLIC INFORMATION- Any information pertaining to a report described in subsection (a) shall be considered to be public information to the extent that the information is necessary--

'(1) to identify the sponsor; and

'(2) to establish the status of a study described in subsection (a) and the reasons, if any, for any failure to carry out the study.

'(c) STATUS OF STUDIES AND REPORTS- The Secretary shall annually develop and publish in the Federal Register a report that provides information on the status of the postmarketing studies--

'(1) that sponsors have entered into agreements to conduct; and

'(2) for which reports have been submitted under subsection (a)(1).'

(b) REPORT TO CONGRESSIONAL COMMITTEES- Not later than October 1, 2001, the Secretary shall prepare and submit to the Committee on Labor and Human Resources of the Senate and the Committee on Commerce of the House of Representatives a report containing--

(1) a summary of the reports submitted under section 506B of the Federal Food, Drug, and Cosmetic Act;

(2) an evaluation of-- (A) the performance of the sponsors referred to in such section in fulfilling the agreements with respect to the conduct of postmarketing studies described in such section of such Act; and (B) the timeliness of the Secretary's review of the postmarketing studies; and

(3) any legislative recommendations respecting the postmarketing studies.

(a) IN GENERAL- Chapter V, as amended by section 130, is further amended by inserting after section 506B the following:

'SEC. 506C. DISCONTINUANCE OF A LIFE SAVING PRODUCT

'(a) IN GENERAL- A manufacturer that is the sole manufacturer of a drug--

'(1) that is-- '(A) life-supporting; '(B) life-sustaining; or '(C) intended for use in the prevention of a debilitating disease or condition;

'(2) for which an application has been approved under section 505(b) or 505(j); and

'(3) that is not a product that was originally derived from human tissue and was replaced by a recombinant product, shall notify the Secretary of a discontinuance of the manufacture of the drug at least 6 months prior to the date of the discontinuance.

'(b) REDUCTION IN NOTIFICATION PERIOD- The notification period required under subsection (a) for a manufacturer may be reduced if the manufacturer certifies to the Secretary that good cause exists for the reduction, such as a situation in which--

'(1) a public health problem may result from continuation of the manufacturing for the 6-month period;

'(2) a biomaterials shortage prevents the continuation of the manufacturing for the 6-month period;

'(3) a liability problem may exist for the manufacturer if the manufacturing is continued for the 6-month period;

'(4) continuation of the manufacturing for the 6-month period may cause substantial economic hardship for the manufacturer;

'(5) the manufacturer has filed for bankruptcy under chapter 7 or 11 of title 11, United States Code; or

'(6) the manufacturer can continue the distribution of the drug involved for 6 months.

'(c) DISTRIBUTION- To the maximum extent practicable, the Secretary shall distribute information on the discontinuation of the drugs described in subsection (a) to appropriate physician and patient organizations.'