FDA Post-Market Drug Safety Workshop To Address Electronic Data Mining

FDA will hold a public workshop May 7 to develop consensus on the use of large electronic health care datasets for post-marketing drug safety reviews.

The agency also seeks public comments on the topic by June 7; the input will help inform an upcoming FDA guidance on the practice.

At the workshop, FDA hopes to gather information from stakeholders on the "design, conduct and interpretation" of pharmacoepidemiologic safety studies using electronic health care databases, according to an April 23 announcement.

The agency will present its experiences in evaluating drug safety reports and expects feedback on the review criteria it should use in such evaluations.

Two panel discussions are planned. The first will address the characteristics of electronic datasets used for safety reviews - such as coverage type or country of data collection - and how they might impact data interpretation.

The second panel will focus on conducting and interpreting studies, including issues such as confounding factors and other challenges to validity.

FDA notes the workshop is a first step in satisfying its commitment under the Prescription Drug User Fee Act IV to identify epidemiology "best practices."

The session is also expected to help the agency build an active post-market surveillance system, as mandated by the FDA Amendments Act of 2007.

In a recent statement, FDA Center for Drug Evaluation and Research Janet Woodcock said the agency is planning a large public-private partnership involving the use of health care datasets to conduct post-market safety monitoring.

Her statement is included in an April 15 announcement by health insurer WellPoint about its new Safety Sentinel drug safety monitoring project ¹ (Also see "WellPoint Drug Safety Monitoring System Expected To Go Live In Mid-2009" - Pink Sheet, 21 Apr, 2008.), p. 18).

- Cathy Kelly ([email protected])