The Food and Drug Administration (FDA) has awarded a contract to Booz Allen Hamilton to conduct a thorough evaluation of the postmarketing study commitment process for collecting medical information. The goal of this in-depth examination is greater internal consistency across the medical Centers at FDA for requiring, requesting, facilitating, and reviewing postmarketing study commitments.

While the effort is most obviously directed at drug marketing, particularly in the wake of the Vioxx withdrawal, it also relates to medical devices because the scope of the analysis covers all the FDA medical product centers including the Center for Devices and Radiological Health (CDRH). The goal is greater internal consistency across FDA's medical product Centers including CDRH, as the Centers require, request, facilitate, and review postmarketing study commitments for drugs, biologic products, and medical devices. By strengthening the process for postmarketing study commitments, FDA is trying to improve its regulation of new medical products by using the best management approaches, the best information technology, and the best quality systems and review processes.

Postmarketing study commitments (PSC), also called Phase 4 commitments, are studies conducted after FDA has approved a product for marketing that a sponsor is required, or has agreed, to conduct. These studies play a vital role in helping to complete the medical community's knowledge concerning the best use of a product because these real-world PMCs are intended to further define the safety, efficacy, or optimal use of a product.
FDA intends to work with drug companies and OEMs to make sure these important commitments are properly focused, properly designed, and ultimately completed in an appropriate time frame to be of value to practitioners and patients. Over the next year Booz Allen Hamilton will examine in-depth the agency's internal processes for PMCs and make recommendations regarding ways to improve these processes and practices.

The evaluation is scheduled to begin this month and take approximately 12 months to complete. Watch DOTmed News for updates.

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