The Food and Drug Administration Modernization Act and the Food and Drug Administration: Metamorphosis or Makeover?

The Food and Drug Administration Modernization Act of 1997 (FDAMA) is the first legislation to bring about significant and widespread modifications to the regulatory environment for drugs and biologicals in more than 35 years. The expectations of what FDAMA is to accomplish are high. This article reviews the results from the first two years of implementation of the major FDAMA provisions for drugs and biologicals. First, however, the elements of the adversarial culture that brought about the impetus to modernize FDA are discussed. Next the article focuses on FDA’s more “modernized” approach to the process of governing, through the use of such mechanisms as governance by guidance, direct final rules, national videoconferences, and stakeholders meetings. In addition, the process for implementing FDAMA and what the products of that process have been, both the rules themselves and the outcomes for the regulated community, are discussed. Lastly, the article considers whether FDA is capable of change and what the real message of FDAMA is.