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THE WHITE HOUSE

Office of the Press Secretary

For Immediate Release November 21, 1997

STATEMENT BY THE PRESIDENT

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.

WILLIAM J. CLINTON

       THE WHITE HOUSE,
       November 21, 1997.

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