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Office of the Press Secretary

For Immediate Release November 21, 1997


November 21, 1997

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.

STRENGTHENING FDA MODERNIZATION INITIATIVES. 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:

BUILDING ON PREVIOUS CLINTON ADMINISTRATION INITIATIVES. 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.