Guest Editorial
- PDF / 1,772,765 Bytes
- 2 Pages / 648 x 864 pts Page_size
- 76 Downloads / 172 Views
247
GUEST EDITORIAL
Guest Editorial
Thomas W. Teal Editor Emeritus
It is a pleasure and an honor to offer this editorial note for the Drug Information Journal to celebrate the centennial of the Food and Drug Administration. Specifically, I have been asked to discuss DIA's impact on the pharmaceutical industry. DIA was founded in Philadelphia in 1962. The founders were an interdisciplinary group of individuals, including pharmacists from hospitaland university-based drug information centers, physicians and other health care professionals, individuals who developed or published drug information resources, and individuals from pharmaceutical companies and government agencies. In its early years, the primary focus of the association was the development and appropriate dissemination and use of information about drugs. At the same time, the pharmaceutical industry was learning to deal with new laws and regulations. Among those were the FDC Act of 1938, which contained as one of its provisions the "requirement of new drugs to be shown safe before marketing"; the Penicillin Amendment, requiring proof of the safety and effectiveness of all penicillin products: and the 1962 Kefauver-Harris Drug Amendments passed "to ensure drug efficacy and greater drug safety." In 1966, FDA contracted with the National Academy of Sciences/National Research Council to evaluate the effectiveness of 4000 marketed drugs previ-
ously approved based on safety alone between 1938 and 1962. In 1968, the FDA formed the Drug Efficacy Study Implementation (DESI) to implement recommendations of that group. The pharmaceutical industry had to respond to these laws and to the new requirements to establish the safety and efficacy of not only new products but also products marketed for years. For example, in Upjohn v. Finch, the Court of Appeals upheld enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy. That industry response changed the way drugs were developed. Recall that the computers of the day were the IBM 1401, which (with expanded memory) could offer 16K of memory. "Anecdotal testimony" by experts was no longer sufficient evidence-the previous method of determining effectiveness. Now, the industry had to prove its products were safe and effective. There were few statisticians, clinical investigators, drug regulatory experts, data processors, or persons with this training and background available to industry. The FDA had similar difficulties recruiting scientists to monitor this new form of drug development. The members of the board of directors of DIA in the mid-1970s were aware of these new requirements and obligations for the drug industry. At this time, board members were primarily
Drug Information Journal. Vd.40.pp. 247-248.2006 0092-8615/2006 Printedin !he USA. All rights resewed. C o p g h t 0 2006 Drug Information Association, Inc.
Downloaded from dij.sagepub.com at NORTH DAKOTA STATE UNIV LIB on May 30, 2015
248
Teal
GUES
Data Loading...
