Postmarketing studies become essential part of new drug development

Postmarketing commitments (PMCs) require drug companies to conduct research on a new drug following market launch and are designed to result in additional information on drug effectiveness, safety and

By Editor on Jul 20, 2004

Postmarketing commitments (PMCs) require drug companies to conduct research on a new drug following market launch and are designed to result in additional information on drug effectiveness, safety and usage, as well as product quality and consistency in manufacturing.

From 1998 to 2003, the U.S. Food and Drug Administration requested PMCs in 73% of its approvals for new drugs. Nearly one-third of the 492 PMCs during the time period were for studies required by the specific regulations for accelerated approvals, deferred pediatric studies and the animal efficacy rule.

The number of new PMCs per new drug increased from 2.7 in the 1970s to 3 in the 1980s, reaching 4.4 by 1998-2003. The number of patients involved in each PMC also has increased from 123 in the 1980s to 920 for 1998-2003.

Efficacy and drug interaction studies were the most prevalent study types from 1998-2003. Requests by the FDA for PMCs vary by drug type. All new anti-infectives approved from 1998-2003 involved PMCs, while only 36% of analgesic, anti-inflammatory and ophthalmic drug approvals required PMCs.

In addition to the estimated $802 million average cost to develop a new drug, pharmaceutical makers spend an average of $95 million per new drug on post-approval R&D, including PMCs.

Given widely shared concerns about the cost and time needed to develop drugs, and increased attention focused on the safety of newly marketed medicines, PMCs may help streamline premarket approval of drugs, while aiding postmarket identification of adverse drug events and other issues related to drug production and use, Christopher Milne, Assistant Director of Tufts's CSDD said.

The move to PMCs is a positive one for the industry and patients, and is critical to bringing much-needed drugs to market more quickly. But it's also one that comes with a big responsibility for the industry to follow through on these commitments with thoroughness and integrity to ensure the practice can continue to grow and foster an environment that speeds drugs to market and protects the health and safety of patients.