The Ethics of Postmarketing Observational Studies of Drug Safety Under Section 505(o)(3) of the Food, Drug, and Cosmetic Act

30 Pages Posted: 15 Mar 2012 Last revised: 2 Jul 2014

See all articles by Barbara J. Evans

Barbara J. Evans

University of Florida Levin College of Law

Date Written: 2012


In 2007, Congress granted the Food and Drug Administration (FDA) new powers to order pharmaceutical companies to conduct drug safety studies and clinical trials in the postmarketing period after drugs are approved. The FDA envisions that these studies will include observational studies that examine patients’ preexisting insurance claims data and clinical records to infer whether drugs are safe in actual clinical practice. While these studies offer a valuable tool for improving drug safety, they raise troubling ethical and privacy issues because they imply widespread use of patients’ health information in commercial research by drug manufacturers. This is the first article to explore the ethics of these sec. 505(o)(3) observational studies, so named after the section of the Food, Drug, and Cosmetic Act that authorizes them.

Data access problems threaten to make the FDA’s sec. 505(o)(3) study requirements unenforceable. Under existing federal privacy regulations, it appears highly unlikely that pharmaceutical companies will have reliable access to crucial data resources, such as insurance claims data and healthcare records, to use in these studies. If pharmaceutical companies do manage to gain access to the needed data, this will raise serious privacy concerns because sec. 505(o)(3) observational studies do not appear to be covered by any of the major federal regulations that afford ethical and privacy protections to persons whose data are used in research.

If the FDA’s program of sec. 505(o)(3) observational studies fails because of the above problems, this failure will have a number of bad consequences: the public will be exposed to avoidable drug safety risks; taxpayers may be forced to bear the costs of having the FDA conduct drug safety investigations that would have been funded by drug manufacturers if data had been available; and, perhaps most troubling, the FDA may be forced to order postmarketing clinical trials to answer questions that could have been answered using observational studies. Problems with access to data for sec. 505(o)(3) studies thus could directly imperil human research subjects by forcing a needless over-reliance on risky postmarketing drug safety trials.

The article concludes by describing a promising new legal pathway for resolving these problems. Congress has provided the FDA a new set of powers that if skillfully exercised will allow the agency: (1) to facilitate pharmaceutical companies’ appropriate access to data for use in sec. 505(o)(3) observational studies, (2) to impose strict ethical and privacy protections for persons whose data are used in these studies, and (3) to mobilize private-sector funding to generate much-needed evidence of the safety of FDA-approved drugs.

Keywords: privacy, food and drug law, section 505(o)(3), postmarketing observational studies, HIPAA privacy Rule, Common Rule

Suggested Citation

Evans, Barbara J., The Ethics of Postmarketing Observational Studies of Drug Safety Under Section 505(o)(3) of the Food, Drug, and Cosmetic Act (2012). 38 American Journal of Law and Medicine 577-606 (2012), U of Houston Law Center No. 2012-A-19, Available at SSRN:

Barbara J. Evans (Contact Author)

University of Florida Levin College of Law ( email )

P.O. Box 117625
Gainesville, FL 32611-7625
United States

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