November 21, 1997
The FDA Modernization Act of 1997
[Note: This backgrounder was written in 1997 to describe the newly passed FDA Modernization Act. The backgrounder has not been revised since that date. ]
The FDA Modernization Act of 1997 is a major legislation focused on reforming the regulation of food, medical products, and cosmetics. The following are the most important provisions of the act:
Prescription Drug User Fees
The act reauthorizes, for five more years, the Prescription Drug User Fee Act of 1992 (PDUFA). In the past five years, the program has enabled the agency to reduce to 15 months the 30-month average time that used to be required for a drug review before PDUFA. This accomplishment was made possible by FDA managerial reforms and the addition of 696 employees to the agency's drugs and biologics program, which was financed by $329 million in user fees from the pharmaceutical industry.
FDA Initiatives and Programs
The law enacts many FDA initiatives undertaken in recent years under Vice President Al Gore's Reinventing Government program. The codified initiatives include measures to modernize the regulation of biological products by bringing them in harmony with the regulations for drugs and eliminating the need for establishment license application; eliminate the batch certification and monograph requirements for insulin and antibiotics; streamline the approval processes for drug and biological manufacturing changes; and reduce the need for environmental assessment as part of a product application.
The act also codifies FDA's regulations and practice to increase patient access to experimental drugs and medical devices and to accelerate review of important new medications. In addition, the law provides for an expanded database on clinical trials which will be accessible by patients. With the sponsor's consent, the results of such clinical trials will be included in the database. Under a separate provision, patients will receive advance notice when a manufacturer plans to discontinue a drug on which they depend for life support or sustenance, or for a treatment of a serious or debilitating disease or condition.
Information on Off-label Use and Drug Economics
The law abolishes the long-standing prohibition on dissemination by manufacturers of information about unapproved uses of drugs and medical devices. The act allows a firm to disseminate peer-reviewed journal articles about an off-label indication of its product, provided the company commits itself to file, within a specified time frame, a supplemental application based on appropriate research to establish the safety and effectiveness of the unapproved use.
The act also allows drug companies to provide economic information about their products to formulary committees, managed care organizations, and similar large-scale buyers of health-care products. The provision is intended to provide such entities with dependable facts about the economic consequences of their procurement decisions. The law, however, does not permit the dissemination of economic information that could affect prescribing choices to individual medical practitioners.
The act creates a special exemption to ensure continued availability of compounded drug products prepared by pharmacists to provide patients with individualized therapies not available commercially. The law, however, seeks to prevent manufacturing under the guise of compounding by establishing parameters within which the practice is appropriate and lawful.
Risk-based Regulation of Medical Devices
The act complements and builds on FDA's recent measures to focus its resources on medical devices that present the greatest risks to patients. For example, the law exempts from premarket notification class I devices that are not intended for a use that is of substantial importance in preventing impairment of human health, or that do not present a potential unreasonable risk of illness or injury. The law also directs FDA to focus its postmarket surveillance on higher risk devices, and allows the agency to implement a reporting system that concentrates on a representative sample of user facilities -- such as hospitals and nursing homes -- that experience deaths and serious illnesses or injuries linked with the use of devices.
Finally, the law expands an ongoing pilot program under which FDA accredits outside -- so-called "third party" -- experts to conduct the initial review of all class I and low-to-intermediate risk class II devices. The act, however, specifies that an accredited person may not review devices that are permanently implantable, life-supporting, life-sustaining, or for which clinical data are required.
Food Safety and Labeling
The act eliminates the requirement of FDA's premarket approval for most packaging and other substances that come in contact with food and may migrate into it. Instead, the law establishes a process whereby the manufacturer can notify the agency about its intent to use certain food contact substances and, unless FDA objects within 120 days, may proceed with the marketing of the new product. Implementation of the notification process is contingent on additional appropriations to cover its cost to the agency. The act also expands procedures under which FDA can authorize health claims and nutrient content claims without reducing the statutory standard.
Standards for Medical Products
While the act reduces or simplifies many regulatory obligations of manufacturers, it does not lower the standards by which medical products are introduced into the market place. In the area of drugs, the law codifies the agency's current practice of allowing in certain circumstances one clinical investigation as the basis for product approval. The act, however, does preserve the presumption that, as a general rule, two adequate and well-controlled studies are needed to prove the product's safety and effectiveness.
In the area of medical devices, the act specifies that FDA may keep out of the market products whose manufacturing processes are so deficient that they could present a serious health hazard. The law also gives the agency authority to take appropriate action if the technology of a device suggests that it is likely to be used for a potentially harmful unlabeled use.