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Abstract

Although [drug] manufacturers bear the cost of research data generation, it is oftentimes a worthwhile investment that also confers significant commercial advantages. Consequently, they have argued that research data should be considered a trade secret and kept confidential. The FDA's longstanding position has been to accept this proposition. Even when Congress appeared to mandate disclosure or weaken the underlying rationale for secrecy, the FDA has continued to treat research data as confidential. A strong argument against a default posture of confidentiality is that research data disclosure would promote broad public interests by eliminating the societal costs brought about by keeping research data out of the reach of the public.[...] Congress weakened the legitimacy of the nondisclosure argument by enacting the Hatch-Waxman Act. Thus, after the Hatch-Waxman Act, the justification for continued secrecy based on the residual commercial value of research data is substantially weaker. The FDA may and should take into account the realignment of interests to revise its confidentiality policy to a default position of disclosure as a matter of public policy. If the FDA fails to act, Congress should explicitly require the agency to make research data publicly accessible, notwithstanding any residual value of the data or its status as confidential business information.[...] This Note proceeds in six parts. Part I begins by first analyzing the theoretical underpinnings of pro-disclosure and pro-secrecy arguments. The problems raised by a policy of research data confidentiality in drug regulation are complex and located within the larger doctrinal question posed by interjecting trade secrets into regulatory frameworks--a "big picture" topic on which a substantial body of scholarship already exists. Here, I do not elaborate on these larger topics, except to summarize existing literature and highlight its relevance to this Note. Part II explores the FDA's evaluation of pro-disclosure and pro-secrecy arguments, its basis for preferring a pro-secrecy stance in its rules implementing the Freedom of Information Act ("FOIA"), as well as its response to the Hatch-Waxman Act's research data disclosure provisions. Part III switches to a survey of the current state of research data confidentiality by discussing how courts have analyzed and evaluated disclosure requests under the FOIA. Part IV concludes the survey of the legal regime of disclosure by briefly exploring statutory and constitutional restraints in addition to the FOIA. Part V reveals the increasing costs of keeping research data confidential by highlighting the heretofore unachievable innovation efficiencies that would become possible under a regime of public access. It focuses on the public interest in ensuring a high standard of scientific quality and integrity in research data, and on the benefits of maximizing our understanding of a drug's mechanism of action and side effects. Finally, Part VI briefly sketches current efforts to achieve full research data disclosure by both private parties and legislatures and points out some means of obtaining that goal.

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