The Food and Drug Administration Modernization Act and the Food and Drug Administration: Metamorphosis or Makeover?
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THE FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT AND THE FOOD AND DRUG ADMINISTRATION: METAMORPHOSIS OR MAKEOVER? CHRISTOPHER-PAUL MILNE,DVM, MPH, JD Senior Research Fellow, Tufts Center for the Study of Drug Development, Tufts University, Boston, Massachusetts
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, howevec 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 f o r the regulated community, are discussed. Lastly, the article considers whether FDA is capable of change and what the real message of FDAMA is. Key Words: FDA Modernization Act; FDAMA; Food and Drug Administration; Rule making
INTRODUCTION
1. Protecting the public health by ensuring
THE FDA MODERNIZATION Act of 1997, which includes the reauthorization of the Prescription Drug User Fee Act (PDUFA), is the first major reshaping of the regulatory landscape for pharmaceuticals since the 1962 amendments to the Food, Drug, & Cosmetic Act. Prior to FDAMA, FDA never had a formal mission statement. In FDAMA, Congress provided one, which focused on three main objectives for drug development:
that the products FDA regulates meet the appropriate agency regulatory standards, 2. Promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a manner which does not unduly impede innovation or product availability, and 3. Participating with other countries to reduce regulatory burdens, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements (1).
Reprints address: Dr. Chris Milne, Tufts Center for the Study of Drug Development, Tufts University, 192 South Street, Suite 550, Boston, MA 021 11.
The expectations for what FDAMA will accomplish are very high. Industry anticipated that FDAMA enhancements to FDA’s
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Christopher-Paul Milne
regulatory procedures along with the PDUFA-mandated dedication of resources to drug approval would shorten drug development time by about a year (2,3). Moreover, passage of FDA reform would finally bring predictability to the drug development process (4). The compromise reached in the passage of FDAMA was to be the
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