Toward a Jurisprudence of Drug Regulation

Author:

Herder Matthew

Abstract

Efforts to ensure greater transparency in the regulation of “drugs” (used here as a catch-all for pharmaceuticals, biologics, medical devices, and biomarker-based technologies such as genetic testing paired with a pharmaceutical or biologic) are well underway. For example, laws in the United States and Europe now require registration of most clinical trials beyond phase 1. Yet instances of avoidable harm to patients continue to arise. In response, calls for disclosure of clinical trial data in the form of “clinical study reports,” not just trial designs and basic results, are growing. In this paper, I argue that disclosure of clinical trial data is necessary but insufficient. Rather, the regulatory decisions that flow from those trial data —whether positive (i.e., product approvals) or negative (i.e., abandoned products, product refusals, and withdrawals) —should also be open to outside scrutiny provided they are final in nature.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference149 articles.

1. Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study

2. 29. A recent decision by the Supreme Court of Canada is illustrative of this emergent transparency. The majority held that the confidential business information exemption from disclosure under the Access to Information Act, R.S.C. 1985, C. A-1, s. 20(1)(b), did not apply on the facts of the case because the information in dispute was, to a large extent, publicly available via the FDA's website. See Merck Frosst Canada Ltd. v. Canada (Health) 2012 SCC 3 at para. 182 [hereinafter Merck Frosst]. Also, in draft proposals intended to increase the transparency of its decision-making, the FDA has specifically highlighted greater levels of transparency at the EMA as a reason to pursue policy change. See FDA, Transparency Report, supra note 27.

3. 23. United States Government Accountability Office, FDA Advisory Committees: Process for Recruiting Members and Evaluating Potential Conflicts of Interest, September 2008, available at (last visited April 14, 2014).

4. Transparency battle resurfaces as EU trial revamp wraps up

5. 131. See Habibi, Lexchin, , supra note 112.

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