Law to reform food, medical product regulation

FDA Consumer, March-April, 1998

President Clinton signed a law last November designed to improve FDA's regulation of food, medical products, and cosmetics. The FDA Modernization Act, the first major food and medical products reform legislation in 35 years, builds on previous agency reforms that have achieved record low approval times for drugs and medical devices.

Key provisions of the law include:

* Reauthorization of the Prescription Drug User Fee Act of 1992 (PDUFA) for five more years. This law has cut the average drug review time in half, while maintaining consumer protection, by using fees from manufacturers to speed up drug reviews.

* Initiatives to streamline biological product regulation and increase patient access to experimental drugs and medical devices.

* Procedures to streamline the filing and approval of new therapies for serious or life-threatening conditions.

* Expanded distribution, by manufacturers, of reliable information about unapproved, or "off-label," uses of drugs and medical devices, provided that manufacturers commit to conducting research and filing supplemental applications for approval of these uses.

* Expansion of a program that allows low-risk medical devices to be reviewed initially for safety and effectiveness by FDA-accredited outside experts.

* Procedures that allow FDA to authorize health and nutrient content claims that link a health benefit to a particular food component.

* Regulation of over-the-counter products under one national system. The law prohibits states from imposing different or additional requirements than those mandated by FDA.