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The FDA Modernization Act of 1997

In 1997, Congress passed legislation amending the Federal Food, Drug, and Cosmetic Act relating to the regulation of food, drugs, devices, and biological products. The legislation, called the Food and Drug Administration Modernization Act, reduces the approval time for drugs and medical devices while seeking to maintain patient safety. In addition, the Modernization Act provides the U.S. Food and Drug Administration (FDA) with additional resources to devote to expediting the drug and medical device review process.

Some of the effects of the Modernization Act are as follows:

The Modernization Act reduced the average time required for a drug review from 15 months to 30 months. This was done by extending the Prescription Drug User Fee Act of 1992, an act which collected fees from drug manufacturers to accelerate the review and approval process. This allowed the FDA to hire additional staff to aid in easing the drug and medical device application backlog.

The Act increased patient access to experimental drugs and medical devices for serious and life-threatening conditions. The Act also provides for the establishment of a database of clinical trials to increase patient access to such trials.

The Act increases consumers’ awareness of new uses for drugs or “off-label” uses. The Act allows drug manufacturers to alert health care providers to off-label uses of their drugs as long as the manufacturers commit to perform additional research and seek approval of the new use.

The Act requires manufacturers to alert patients prior to discontinuing a drug on which the patient relies for treatment of a serious or life-threatening condition.

The Act directs the FDA to focus its post-market surveillance efforts on the products that are of the greatest risk to patients. To accomplish this, the Act exempts from pre-market notification medical devices that are not of substantial importance in preventing impairment of human health or that do not pose a high risk of illness or injury.

In addition to expediting the drug approval process, the Modernization Act eliminates the pre-market approval requirement for food packaging. Instead, food manufacturers need only notify the FDA of their intent to use a particular form of packaging. If the FDA fails to object within 120 days, the manufacturer is free to use the packaging.

The Act does not change the presumption that two clinical studies are required to prove the safety and efficacy of a drug. As before the Act, the Act preserves the exception for approval of some drugs and devices after only one clinical investigation.