On Nov. 21, 1997, the U.S. Food and Drug Administration (FDA) Modernization Act (FDMA) was signed into law by President Bill Clinton. The Act reauthorized the Prescription Drug User Fee Act of 1992 and mandated the first comprehensive revision of the Nation’s food, drug, and medical device laws in 30 years. This statute established new standards for product review and regulatory approval under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Several of the changes made by the new law codify regulatory initiatives undertaken previously by the FDA. 

Title I deals with various drug regulatory concerns. Key provisions include a five-year reauthorization of the Prescription Drug User Fee Act allowing the agency to charge manufacturers fees to facilitate the review of new drugs and biological products. Manufacturers who conduct additional studies to enhance pediatric labeling for products will qualify for six months additional marketing exclusivity, and drugs to treat life-threatening conditions will be given fast track consideration. In addition, drug approval norms will be eased by reducing the number of clinical investigations needed and granting manufacturers the latitude to submit abbreviated study reports. Agency guidance documents will be issued to streamline the drug review process and provide a means for resolving controversial scientific issues.

PDUFA was enacted in 1992 and authorized the FDA to collect user fees from pharmaceutical and biotechnology companies for the review of certain human drug and biological products. With respect to products covered by PDUFA, the FDA committed to certain review performance goals, procedural and processing goals, and other commitments. Provisions include measures to accelerate review of devices, regulate advertising of unapproved uses of approved drugs and devices, and regulated health claims for foods.

Requirements for medical device approval and postmarket surveillance are addressed in Title II. The measure seeks to improve the premarket review process by requiring clarity, timeliness, and better communication between the FDA and regulated industry. Regulatory issues addressed include investigational device exemptions, premarket notification, special review, humanitarian uses of devices, device standards, data requirements, classification, and development protocols. Moreover, a third-party review program is established to expedite the review of certain Class I and II devices. Regulatory requirements are reduced for such postmarket activities as tracking, surveillance, and reporting.

Title III addresses several food regulation issues. It allows expedited procedures for the use of new nutrient content and health claims and specifies timely action on claims petitions. It also allows nutrient content and health claims to be made based on authoritative statements issued as current policy of relevant scientific agencies. The Act amends the food irradiation provisions to prohibit labeling requirements that are more prominent than the ingredient listing, and it requires a timely decision on review of the pending red meat irradiation petition. Further, the law establishes a notification system for food contact substances.

Title IV permits the dissemination of information about “off-label” uses of drugs or devices not yet approved by the FDA. Other provisions allow patients expanded access to investigational therapies, encourage international harmonization agreements, and establish national uniformity in the regulation of nonprescription drugs and cosmetics.

For the first time, the FDA must conduct its regulatory functions under a mission statement that will obligate it to maintain a public health protection role while seeking to expedite the marketing of regulated products.