Modernization Act of 1997

This commentary provides an overview of the events leading up to the signing of the FDA Modernization Act of 1997. It also discusses the rationale for the legislation, and summarizes the major provisions.

Hyman, Phelps & McNamara, P.C. (HP&M), the author of this piece, is a Washington, D.C., law firm that specializes in FDA law and regulations.

The Food and Drug Administration Modernization Act of 1997 (Modernization Act) is the culmination of a comprehensive legislative reform effort designed to streamline regulatory procedures within the Food and Drug Administration (FDA) and to improve the regulation of drugs, medical devices, and food. Passed by the 105th Congress on November 9, 1997, the bill was signed by President Clinton on November 21. Enjoying wide bipartisan support, the legislation is principally designed to ensure the timely availability of safe and effective drugs, biologics, and medical devices by expediting the premarket review process for new products, while maintaining FDA's "gold standard" for product approval. The majority of the provisions of the Modernization Act take effect on February 19, 1998.

Since passage of the Federal Food and Drugs Act in 1906, and the Federal Food, Drug, and Cosmetic Act (FDC Act) in 1938, FDA's regulatory role has expanded considerably from that of removing unsafe or misbranded products from the marketplace, to determining whether drugs and medical devices are safe and effective for their intended use. FDA's ability to accomplish the duties embodied in this expanded role, however, has not kept pace with the agency's statutory responsibilities, resulting in an overly burdensome regulatory system. The requirements for the clinical testing and premarket review of new products have become increasingly complex, time-consuming, and costly. As a result, patients have been denied timely access to safe and useful drugs and medical devices. In short, during the past twenty years, every administration has recognized the need for reforming FDA and modernizing the agency's product approval system to achieve an appropriate balance between safeguarding the public from risk and facilitating the development, testing, and timely approval of safe and effective products that benefit the public health.

This important legislation improves FDA's public accountability and establishes, for the first time, an FDA mission statement that helps define the scope of the agency's regulatory responsibilities. The legislation amends the FDC Act to require the Secretary of Health and Human Services hereinafter FDA) to prepare a plan for implementing FDA's statutory compliance in consultation with appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry. FDA's compliance plan must be published in the Federal Register and reviewed biannually by the agency. This is intended to eliminate backlogs in the drug and medical device approval process and ensure the timely review of applications. As part of the agency's new mission statement, FDA must promptly and efficiently review clinical research and take appropriate action on the marketing of regulated products so that innovation and product availability are not impeded or discouraged.

The legislation improves the regulation of medical devices through reforms that relate to the review of applications, standards, and data requirements. For example, the legislation includes a provision that mandates priority review for breakthrough technologies in medical devices and grants FDA the authority to contract with outside scientific experts for the review of medical device applications.

The Modernization Act provides a legislative framework that embodies many of the bipartisan conclusions and recommendations made during the past 20 years by expert administrative advisory panels and congressional committees concerned with FDA reform. The legislation reflects congressional concern that FDA's past regulatory practices have hindered the dynamic and innovative growth of America's pharmaceutical, biotech, medical device, and food industries and that the agency has been out of step with recent scientific and technological advances in the development and testing of new products.

During the past few years, these concerns have become more pressing both for Congress and the President, particularly in light of U.S. efforts to harmonize regulatory requirements with other national regulatory authorities, and the European Union's move to adopt a uniform approval system for drugs and medical devices. By streamlining functions at FDA and eliminating outdated regulatory requirements, the legislation addresses an overly complex, burdensome, and expensive regulatory system to make it ready for the 21st century.