HealthLawProf Blog

Editor: Katharine Van Tassel
Concordia University School of Law

Monday, May 6, 2013

Petrie-Flom Conference on the FDA--and Transparency of Clinical Trial Data

This year's Petrie-Flom Conference was devoted to the FDA in the 21st Century. If the distribution of conference papers is any harbinger, it appears likely that food is and will continue to play a diminishing role in the agency's future.  Out of the two days of panels, only ONE was devoted to food.  Moreover, the dependence of the FDA on user fees for any funding increases can only be expected to swell the sections of the agency devoted to drugs and devices while food regulation languishes--the Food Safety Modernization Act (FSMA) notwithstanding. Obesity, it seems, is a medical (or public health) problem, not a food problem. In general, however, the conference was a wonderful confluence of FDA history, FDA policy, and FDA possibilities.  I strongly urge blog readers to check out the liveblogging from the conference (on the link above in this paragraph, as well as the conference recording when it appears).

For readers of this blog, one of the more relevant discussions concerned transparency in clinical trial data. Trudo Lemmens called attention to the just-issued interim ruling of the General Court of the EU regarding document release by the European Medicines Agency (EMA).  Two pharmaceutical manufacturers, AbbVie and InterMune, challenged the EMA's decisions to grant access to non-clinical and clinical information (including clinical study reports) submitted by companies as part of marketing-authorisation applications. The EMA's decisions to release were taken in accordance with its 2010 access-to-documents policy.  This access policy aims to protect the privacy of individual data while allowing independent scrutiny of the results of clinical trials; the EMA has announced that it will continue the policy for other document requests not at issue in the interim ruling. 

Worth reading on the subject of transparency more generally is Lemmens' recent article in JMLE on human rights and pharmaceutical knowledge governance. In the article, Lemmens argues that pharmaceutical companies' control over knowledge production is a significant global public health problem.  Viewing the issue in human rights terms can prioritize it on the public policy agenda and blunt restrictions on information access based in trade obligations and trade secrets.  Lemmens bases the human rights argument in the human right to health which, he contends, creates obligations for states to implement determinants of the right to health, including information.  Lemmens also suggests grounding in the right to life for production of important safety information.  Privacy is invoked on the other side of data transparency--as indeed it was during the discussions at Petrie Flom.  In response, Lemmens notes the irony of invoking protection of individuals in one dimension--privacy--against protection of individuals in another dimension--health and safety.  As a solution, he suggests that the apparent impasse should be transcended by models "based on meaningful citizen involvement in public health-oriented science." Lemmens also defends establishment on an international framework for sharing clinical trial safety and effectiveness data, given the global structure of pharmaceutical research today.


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