US FDA commits to PMS; awards contract

The US Food and Drug Administration has awarded a contract to Booz Allen Hamilton to conduct a thorough evaluation of the post-marketing study commitment process for collecting medical information. The goal of this in-depth examination, due to start this month, is greater internal consistency across the medical centers at the FDA for requiring, requesting, facilitating and reviewing post-marketing study commitments, says the agency.

The move follows the recent revelation that around 65% of the post-market studies that pharmaceutical companies said they would carry out after product approvals had not been started by September 30, 2005, and that Senators Chuck Grassely and Christopher Dodd had introduced a bill in the US Congress that would give the FDA authority, which it does not have, to require post-marketing studies to be carried out (Marketletter March 13).

Post-marketing study commitments, also called Phase IV commitments (PMCs), are studies conducted after the 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 PMCs are intended to further define the safety, efficacy, or optimal use of a product.