63 Food and Drug Law Journal 321-374 (2008).
Gene therapy clinical research in the United States is regulated by FDA, and to a lesser degree, by NIH. During the period between 1999 and 2001, both of these agencies separately went about modifying their regulations to explicitly deny confidential status to gene therapy safety reports submitted to the respective agencies, or in the case of the Food and Drug Administration, to affirmatively require public disclosure of such information over the Internet.
The Biotechnology Industry Organization (BIO) responded with comments to the proposed changes of each agency. Although these proposals were modified or withdrawn before the dispute ever elevated into litigation, statements made by the agencies and by BIO indicate the postures that the parties would have taken if they ultimately resorted to court. This paper provides history and background on the regulation of gene therapy by FDA and the NIH, and describes the body of law (reverse FOIA) that would have governed the dispute had it gone to trial.
Finally, the paper discusses the regulations proposed by NIH and FDA, the reverse FOIA arguments offered in support of and against such regulations, analyzing these arguments and evaluating additional arguments that had not been discussed by the parties.