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63 Food & Drug L.J. 321 (2008)
Reverse-FOIA Limitations on Agency Actions to Disclose Human Gene Therapy Clinical Trial Data

handle is hein.journals/foodlj63 and id is 351 raw text is: Reverse-FOIA Limitations on Agency Actions to Disclose Human Gene Therapy Clinical Trial Data EvAN DIAMoND* I. INTRODUCTION Presumably, if we can create a category of releasable data by regula- tion, as, for example, we could attempt to do conceivably in the case of safety and efficacy data, we would then be challenged in court. There would ultimately be a judicial judgment about the intent of Congress in that matter. That is one way to go. The other way to go is to change it. - Donald Kennedy, FDA Commissioner, 1977 Commissioner Kennedy chose the latter path, and did not succeed. The law governing the confidentiality of safety and effectiveness data submitted to the Food and Drug Administration (FDA) during premarket clinical trials has not changed substantially between 1977 and today. But between 1999 and 2001, FDA and the National Institutes of Health (NIH) tested the road not taken by Commissioner Kennedy, each seeking to achieve by administrative action the disclosure of clinical safety data from privately funded human gene therapy research. The biotechnology industry objected vigorously, and laid the groundwork for what could have been a lawsuit of the sort prophesized by Commissioner Kennedy. This article places the NIH and FDA regulation of human gene therapy clinical research in its historical context, and then explores the legal basis for the positions staked out by the NIH, FDA, and the Biotechnology Industry Organization (BIO) over the confidentiality of safety and effectiveness data produced in the course of such research. It then details the legal substance of this conflict, and finally provides some legal analysis beyond that which was done by the parties to the dispute. H. A BRiEF HISTORY OF THE REGULATION OF GENE THERAPY A. NIH Oversite 1. Formation of the NIH Guidelines In 1971, scientist Paul Berg announced a plan to join a tumor virus gene with a bacterial DNA sequence for insertion into E. Coli.' At a 1973 conference, several other scientists recommended that the scientific community refrain from combin- ing animal viruses with bacterial DNA until the National Academy of Sciences (NAS) establish a study committee to evaluate the safety of such experiments Mr. Diamond is an Associate in the law firm of Kirkland & Ellis LLP, New York, NY. This paper won Honorable Mention in the 2007 H. Thomas Austern Memorial Writing Competition spon- sored by The Food and Drug Law Institute. See Judith P. Swazey et al., Risks and Benefits, Rights and Responsibilities: A History of the Recombinant DNA Research Controversy, 51 S. CAL. L. REV. 1019, 1022 (1978); Joseph M. Rainsbury, Biotechnology on the RAC-FDAINIH Regulation of Human Gene Therapy, 55 FOOD & DRUG L.J. 575, 575-576 (2000).

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