Strengthening and Modernizing the FDA

President Clinton Signs Law to Strengthen and Modernize the FDA:

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. This 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.

CONTINUING TO MODERNIZE THE FDA
FDA modernization efforts already underway have reduced drug and medical device approval times to record lows while maintaining consumer protections. Under the President's leadership, the FDA has also ensured that the unique needs of children are protected. The law President Clinton signed today not only builds on this effort, but also expands the FDA's resources. Key provisions of the new law include:

Getting Drugs Approved Faster. The law reauthorizes for five years the Prescription Drug User Fee Act of 1992, which 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 -- from 30 months to 15.

Reducing Requirements and Simplifying the Review of New Drugs and Medical Devices. The law enacts many FDA initiatives undertaken in recent years under the Vice President's Reinventing Government initiative, reducing the requirements and simplifying the review process for new drugs and medical devices without compromising safety.

Offering Hope to Critically Ill Americans. The law offers new hope to critically ill Americans by expanding access to drugs and therapies whose FDA approvals are still pending. Because for many patients experimental treatments represent their best chance for recovery, 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 with these experimental therapies. At the Administration's urging, the law also expands the database on clinical trials of drugs that fight serious illnesses so that patients can keep track of their progress.

Protecting Consumers. The Act also protects consumers by specifying that the FDA may ban devices produced in a seriously deficient manner, and by giving the agency explicit authority to take preventive action if a device is likely to be used "off-label" for a potentially harmful, unapproved use.

Ensuring Accurate Food Labeling. The Act expands procedures for the FDA to authorize health and nutrient content claims -- which link a health benefit to a particular food component -- without weakening the current requirement that the information be truthful and scientifically valid.

November 1997

November 13, 1997

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November 21, 1997

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