Health Hippo: Drugs

US CODE || GAO || CASE LAW || NEWS || RELATED LINKS

The FDA Modernization Act dramatically changes the regulation of drugs. Here are the links. To search the entire Act, put your terms into HippoSearch, then use your browser's "find" command to pinpoint them on the retrieved page(s).

TITLE I--IMPROVING REGULATION OF DRUGS

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

Antonio Benedi regularly drank 3 or 4 glasses of wine during the week and sometimes more on weekends. In 1993, Benedi was taking Extra-Strength Tylenol in regular doses for about 5 days when he fell into a coma and nearly died from liver and kidney failure. Two days later, Benedi received an emergency liver transplant. The physicians who examined Benedi's removed liver agreed that the the damage was caused by acetaminophen toxicity and a jury later awarded Benedi over $8 million in his lawsuit against McNeil-P.P.C. The 4th U.S. Circuit Court of Appeals affirmed the verdict in BENEDI v. MCNEIL-P.P.C., INC. Over the summer, Mr. Benedi moved into commercials, starring in ads for rival Advil. See All About Health: The Problem With Pain Pills; Global NewsWeb: Whitehall-Robins Urges Consumers To Continue To Heed Warning About Tylenol And Alcohol; Company Reaffirms Veracity Of Advil Ad .

U.S. Code

GAO Reports

Prescription Drugs: Implications of Drug Labeling and Off-Label Use. GAO/T-HEHS-96-212. 8 pp. Sept. 12, 1996.
Medicaid: Changes in Best Price for Outpatient Drugs Purchased by HMOs and Hospitals (Fact Sheet, 08/05/94, GAO/HEHS-94-194FS). Congress has tried to reduce Medicaid prescription drug costs by requiring drug manufacturers to give state Medicaid programs rebates for outpatient drugs.
Nonprescription Drugs: Value of a Pharmacist-Controlled Class Has Yet to Be Demonstrated (Chapter Report, 08/24/95, GAO/PEMD-95-12) GAO reviewed the creation of a drug class that would be available only through pharmacies, but would not require a physician's prescription.
Pharmacy Benefit Managers: Early Results on Ventures with Drug Manufacturers (Letter Report, 11/09/95, GAO/HEHS-96-45). GAO reviewed mergers between pharmacy benefit managers (PBM) and pharmaceutical manufacturers.
Prescription Drugs and the Elderly: Many Still Receive Potentially Harmful Drugs Despite Recent Improvements (Letter Report, 07/24/95,GAO/HEHS-95-152). GAO examined the elderly's inappropriate use of prescription drugs.
Prescription Drugs: Automated Prospective Review Systems Offer Significant Potential Benefits for Medicaid (Letter Report, 08/05/94,GAO/AIMD-94-130). Use of automatic systems linked to statewide databases could provide a more thorough prospective review than reviews based on manual or local systems.
Prescription Drugs: Spending Controls in Four European Countries (Chapter Report, 05/17/94, GAO/HEHS-94-30). Although the United States has traditionally allowed drug prices to be determined by the free market, other countries use a variety of policies to control prescription drug costs.

Cases

BENEDI v. MCNEIL-P.P.C., INC. (4th Cir., October 10, 1995) (upholding $8 million award for liver damage caused by mixing alcohol with Tylenol)

News & Reports

FDA News The latest from the Food and Drug Administration.
Generic Drug Equity Generic versions of some of this country's most widely prescribed medicines will be kept off the market due to a Food and Drug Administration (FDA) interpretation of a General Agreement on Trade and Tariffs (GATT) Treaty provision.
LEGAL RESTRICTIONS ON THE ADVERTISING AND PROMOTION OF PHARMACEUTICAL AND BIOLOGICAL PRODUCTS ON THE INTERNET There is thus little to guide companies who are contemplating marketing over the INTERNET and other new methods of electronic communication except current laws, regulations, and regulatory guidance.
Making Your Voice Heard at FDA As a regulatory agency, FDA publishes rules that establish or modify the way it regulates foods, drugs, biologics, cosmetics, radiation- emitting electronic products, and medical devices-- commodities close to the daily lives of all Americans.
Pharmacy Case Review Pharmacy Case Review is a peer-reviewed, electronically distributed journal dedicated to educational scholarship serving as a curricular resource in pharmacy and related health care education.
Pharmoeconomics Journal Lists the contents of past, current and future journal articles.
State Marijuana Laws (a compilation of all the state laws relating to marijuana possession)
UConn gopher: Biomedicine & Health in the news Indexes articles from the New York Times and the Minneapolis Star-Tribune.