FDA wants to ensure that postmarket trials get done

Many acknowledge that the system is deeply flawed, but solutions seem elusive.

By Victoria Stagg Elliott, AMNews staff. April 3, 2006.

Have you ever wondered which nonsteroidal anti-inflammatory drug is the best choice for elderly patients with osteoarthritis? Are there risks associated with the long-term use of benzodiazepines to treat panic disorder? How do some asthma medications interact with the other pharmaceuticals? Or how does a certain drug affect women who are pregnant or patients younger than 18?

These are the kinds of questions that the Food and Drug Administration hopes will be answered when it requests a postmarketing study. These investigations, which are conducted after a drug or biologic's approval, are usually triggered by suspicions that their results could protect patients and further guide physicians in treatment decisions.

The answers, however, are a long time coming -- if they arrive at all. And the FDA is now stepping up efforts to ensure that this research, also known as phase IV studies, gets done.

According to recent FDA tracking reports, including one issued last month, a few hundred of these trials are finished each year, but hundreds more may be falling through the cracks. Meanwhile, a review of the agency's postmarketing commitment database found a multitude of uncompleted inquiries.

"We fully intend to work with sponsors to make sure these important commitments get completed," said FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, MD, in a Feb. 8 speech to the American Enterprise Institute in Washington, D.C.

But seeing this challenge through will require the FDA and the industry to address a number of technical and systemic barriers.