- 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. 201. Investigational device exemptions
- SEC. 202. Special review for certain devices
- SEC. 203. Expanding humanitarian use of devices
- SEC. 204. Device standards
- SEC. 205. Scope of review; collaborative determinations of device data requirements
- SEC. 206. Premarket notification
- SEC. 207. Evaluation of automatic class III designation
- SEC. 208. Classification panels
- SEC. 209. Certainty of review timeframes; collaborative review process
- SEC. 210. Accreditation of persons for review of premarket notification reports
- SEC. 211. Device tracking
- SEC. 212. Postmarket surveillance
- SEC. 213. Reports
- SEC. 214. Practice of medicine
- SEC. 215. Noninvasive blood glucose meter
- SEC. 216. Use of data relating to premarket approval; product development protocol
- SEC. 217. Clarification of the number of required clinical investigations for approval
- SEC. 301. Flexibility for regulations regarding claims
- SEC. 302. Petitions for claims
- SEC. 303. Health claims for food products
- SEC. 304. Nutrient content claims
- SEC. 305. Referral statements
- SEC. 306. Disclosure of irradiation
- SEC. 307. Irradiation petition
- SEC. 308. Glass and ceramic ware
- SEC. 309. Food contact substances
- SEC. 401. Dissemination of information on new uses
- SEC. 402. Expanded access to investigational therapies and diagnostics
- SEC. 403. Approval of supplemental applications for approved products
- SEC. 404. Dispute resolution
- SEC. 405. Informal agency statements
- SEC. 406. Food and Drug Administration mission and annual report
- SEC. 407. Information system
- SEC. 408. Education and training
- SEC. 409. Centers for education and research on therapeutics
- SEC. 410. Mutual recognition agreements and global harmonization
- SEC. 411. Environmental impact review
- SEC. 412. National uniformity for nonprescription drugs and cosmetics
- SEC. 413. Food and Drug Administration study of mercury compounds in drugs and food
- SEC. 414. Interagency collaboration
- SEC. 415. Contracts for expert review
- SEC. 416. Product classification
- SEC. 417. Registration of foreign establishments
- SEC. 418. Clarification of seizure authority
- SEC. 419. Interstate commerce
- SEC. 420. Safety report disclaimers
- SEC. 421. Labeling and advertising regarding compliance with statutory requirements
- SEC. 422. Rule of construction
SEC. 501. Effective date
Today, President Clinton signed into law "the FDA Modernization Act of 1997, critical legislation that will improve the regulation of food, medical products and cosmetics, and prepare the FDA for the 21st century. This new law represents the culmination of several years of effort by the Administration and Congress to reach common ground on how to amend the drug, device, and food laws. The Act, the first major food and medical products reform legislation in 35 years, includes numerous initiatives championed by the Clinton Administration that will ease the regulatory burden on industries, protect consumers, and cut red tape, making government operations faster and more efficient.
The new law builds on FDA modernization efforts already underway which have reduced drug and medical device approval times to record lows while maintaining consumer protections. The new law also expands the resources available to the FDA to carry out its mission. Key provisions of the new law include:
Under the Clinton Administration, the FDA has made significant progress in streamlining its review processes to ensure that consumers gain access to important new drugs and medical devices as quickly as possible. At the same time, the FDA has continued to protect consumers by working with public and private sector partners to ensure that the foods, drugs, cosmetics, and medical products that consumers buy are the safest available.
As a result of innovations led by the FDA, Americans with cancer, AIDS, Alzheimer's disease, multiple sclerosis, and other serious conditions now have access to major innovative drugs much sooner. To date, the agency has cut new drug approval times nearly in half, while the number of new drugs approved in a year has doubled.
In recognition of its innovations of the U.S. drug approval process, the FDA was named a 1997 winner of the prestigious Innovations in American Government Awards Program, sponsored by the Ford Foundation and Harvard University's John F. Kennedy School of Government. In addition, in August 1997, the FDA unveiled a new regulation that will protect children by requiring drug manufacturers to study the safety and appropriate dosage levels of medications for pediatric populations. The regulation also requires proper labeling of drugs for use by children.
THE PRESIDENT: Thank you very much. After Secretary Shalala made you all laugh she reminded me that she has to go catch a plane -- she's going on a trip to Asia and she's winding up in Butung. She said, you know, some people think Butung is the most beautiful place in the world, and the King is there and he's got four wives and they're all sisters. And she said, I wonder if he'd like four and a half. (Laughter.) I thought the private joke was even better than the public one, so I thought I'd give credit.
Let me, first of all, thank the Vice President and his reinventing government staff for the work that they have done on the FDA, and Secretary Shalala and all the people at HHS, and Sally Katzen and the people at OMB, and folks in the White House, the industry leaders who are here. But let me especially thank the members of Congress, all those who are here and at least two who are not -- Congressman Bliley and Congressman Dingell -- for the work that -- this really astonishing work.
It was a two-year process. This bill passed by a voice vote in both Houses. And yet it is a very significant overhaul in the work of the Food and Drug Administration. It also, it seems to me, is symbolic of what we should be doing as a country.
The FDA, which was created under Theodore Roosevelt, as the Vice President said, is really I think one of the signal achievements of the Progressive Era. Why was it necessary? Because more and more people were moving from the farm to the city and making a living in factories, and instead of consuming the food that they raised on their own farms, they had to go down and buy the food from somebody else. And more and more people had access to doctors, and doctors had access to medicine that was being discovered that they couldn't know everything about. So somebody needed to say, hey, this medicine is okay, we've tested it, it's okay, you can give it to your patients in Iowa or Oregon or Arizona or Alabama.
And so a whole new world of possibility opened when people could move from farm to factory and when people could have access to a doctor when they couldn't see one before. But there needed to be someone who said, here's the public interest in trying to make sure the food is safe and the drugs are safe and they do what they're supposed to do.
And it's worked stunningly well, really. Throughout the entire Industrial Era of the 20th century our country has continued to see its life expectancy increase and its economy grow and diversify. But when I was out there -- the Vice President is right -- I brought this up in our transition back in '92, because when I went across the country in 1992, everywhere I went people were complaining, on the one hand, that they were beginning to be concerned about some food safety issues, and on the other hand, that the health and welfare of the American people was actually being undermined by a system in the FDA that at least the people who were involved in it thought was too slow and somewhat arbitrary and not giving the American people the drug approvals and the medical device approvals in a timely fashion.
So we set to work on it and we found there was an enormous amount of interest in the Congress. The Vice President's right, the FDA deserves, I think, a great deal of credit for the internal changes that have been made, that have been recognized, and particularly on the drug approvals, the speed of them.
But this legislation, I think, is very, very important. And again I say, it is also symbolic of a larger mission we should be about. We're maintaining and redefining the public interest at a time when there are new challenges to food safety, which we've tried to meet, partly in the Department of Agriculture and partly with some important bipartisan legislation the Congress passed about a year ago, and when we have new possibilities in both medicine and medical devices -- and what we want to do is get those to people as quickly as possible and still protect the public interest.
And we know now we have new options for that because of the change, again, in the underlying nature of the society, moving from the Industrial Age to a technology, computer information dominated age in which we have a lot more opportunities to do things that will speed this approval process, and on the other hand, in the food area, we know because we've now gone from seeing people get their food from their neighbors who were farmers while they lived in the cities -- that food has become more and more and more an international commodity. And we have an even higher responsibility not only through the FDA, but generally through the government to secure the safety of our food supply.
So I think the changes we are making are very important not only on their own merits, but because what you have done is a model for what America has to do in area after area after area -- clearly define the public interest and then change they way we pursue it consistent with the tools and the responsibilities and the opportunities available in this time. And all of you should be very, very proud of that.
Let me say that, as everybody knows, this bill is the product of three years of hard work that involves all the people I have already mentioned. I just think it's worth pointing out that at the beginning of the process the sides stood worlds apart. I think that is an understatement. (Laughter.) And the fact that there was a process by which you could think through differences and build a true consensus that is bipartisan and involves all the stakeholders, resulting in a bill -- if somebody told me two years ago, two years from now you'll be standing over at the Old OEOB and you'll be about to sign a bill that passed the Congress by a voice vote and it will have more than two words in it, so it won't be an empty bill, it will, in fact, be a sweeping reform of FDA, I would have taken odds against that. And I think you should all be very, very proud of yourselves.
Let me just highlight a few of the bill's provisions. First, we continue working with the business community to get more drugs approved faster. We've reauthorized the Prescription Drug User Fee Act for five more years. It ensures that the cost of reviewing and approving drugs is shared between industry and government. Since 1992, these additional revenues have helped FDA hire some 600 more employees, cutting drug approval time in half already, and we want to do better.
Second, the bill writes into law many of the Reinventing Government measures introduced by FDA a few years ago, reducing the requirements and simplifying the review process for new drugs and medical devices without compromising safety. And I congratulate the Vice President for all his work particularly on this effort.
Third, we will offer new hope to critically ill Americans by expanding access to drugs and therapies whose FDA approvals are still pending. Anybody who's ever had a family in this situation knows what an important part of the legislation this is. We know that for many patients experimental treatments represent their best, perhaps their only, chance for recovery. That's why this bill writes into law current FDA policies that allow doctors and patients to use new drugs before they are formally approved. Already, thousands of AIDS, cancer and Alzheimer patients have found new hope, even new life, with these experimental therapies. We will also expand the database on clinical trials of drugs that fight serious illnesses so that patients can keep track of their progress.
It's been said that while the century we are about to leave has been an age of physics, the 21st century will be an age of biology, perhaps yielding cures to diseases we thought incurable. We are already witnessing the medical possibilities of the future, as the Vice President said. This fall alone, the FDA has approved new drugs and treatments for everything from HIV to breast cancer, cardiovascular disease to cystic fibrosis, Parkinson's to epilepsy.
The FDA has served America well. Today, with a bill I'm about to sign into law, we can ensure that it will serve America well into the 21 century, and I hope serve as a model again for how we can maintain our goals of pursuing the public interest and adjust our means to the possibilities and the challenges of a dramatically new era. The FDA has always set the gold standard for consumer safety. Today it wins a gold medal for leading the way into the future. And thank you all.
I'd like to ask the Congressmen now to join me up here so we can sign the bill. Thank you. (Applause.)
END
9:59 A.M. EST
I am pleased to sign into law S. 830, the "Food and Drug Administration Modernization Act of 1997." This bipartisan legislation culminates several years of work by my Administration and the Congress on steps to streamline and rationalize the process by which the Food and Drug Administration (FDA) approves new drugs and medical devices, while ensuring that these products, on which the American people rely, are safe and effective. The Act represents the most comprehensive reform of our Nation's drug, medical device, and food laws in decades. I believe that it is a good compromise on a difficult set of issues and am pleased that the Congress and my Administration were able to work through these issues and enact a bipartisan bill. Most importantly, I am pleased that S. 830 addresses my key concern that any FDA legislation maintain our high standards to protect the American people from dangerous drugs, devices, and foods.
This legislation will extend through Fiscal Year 2002, the Prescription Drug User Fee Act, which requires drug companies to help underwrite the cost of FDA reviews of their products' safety and efficacy. This measure has enabled the FDA to eliminate backlogs and significantly shorten the review time of new human drug applications without compromising quality standards. Supported by the drug industry, the Prescription Drug User Fee Act illustrates the true benefits of a public-private partnership.
Certainly, FDA reform did not start with this bill. The Vice President has been working on reforming and reinventing the FDA since 1993. This bill codifies many of the reforms proposed by the Vice President's Reinventing Government Initiative. For example, it modernizes the regulations of biological products, eliminates the batch certification and monograph requirements for insulin and antibiotics, and streamlines the approval process for drug manufacturing changes. This Act also codifies reforms proposed by the FDA's Center for Devices and Radiological Health that will significantly improve both the rigor and timeliness of its premarket review of medical devices.
Notably, S. 830 will expand FDA's current program to streamline the filing and approval of new therapies for serious or life-threatening conditions. It will also codify FDA regulations and practices designed to ensure that patients will have access to therapies for serious and life-threatening conditions before they are approved for marketing. The Act requires the Department of Health and Human Services to establish a databank, providing information to the public on clinical trials of experimental treatments for serious and life-threatening conditions.
In addition, S. 830 includes a provision that eliminates certain health information dissemination restrictions, while maintaining public health protections. For example, product sponsors, manufacturers, or distributors will now be permitted to furnish to health professionals, providers, and others, peer-reviewed journal articles on an "off-label" use of an approved or cleared drug or device, so long as the manufacturers commit to completing the research needed to approve such use and meet other specified conditions. Drug manufacturers will also be able to give cost data to health maintenance organizations and other institutional purchasers of prescription drugs, so long as it is based on competent and reliable scientific evidence. The Act will also resolve the issue of pharmacy compounding -- the process of making customized medicines -- so that legitimate pharmacy compounding is allowed, while the manufacture of unapproved drugs is not.
While I am satisfied with the resolution of the issues in this legislation, I am also pleased that the Congress included sunsets to certain of the Act's provisions so that, at the appropriate time, we can evaluate whether the proper compromises were reached. As FDA reform did not start with this bill, it will not end with this bill. Even with the streamlining provided in S. 830, the FDA will continue to face the challenge of fulfilling its many responsibilities and requirements within available resources. The Vice President and I look forward to continuing our work with patient groups, industry, and the Congress to make sure that the FDA is meeting the challenges of the future and providing safe and effective products to all Americans.