Healthy Skepticism Library item: 13554

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Publication type: news

Blum J.
Drugmakers Didn't Begin 1,044 Promised U.S. Studies
Bloomberg.com 2008 Apr 23
http://www.bloomberg.com/apps/news?pid=20601202&sid=acu6znqklhBo&refer=healthcare

Full text:

Drugmakers haven’t made progress in starting studies that they promised to conduct after their products were approved by U.S. regulators, according to data released today.

The Food and Drug Administration determined that 1,044, or 62 percent, of incomplete studies for conventional drugs and biotechnology medications had yet to be started as of Sept. 30. At the same time in 2006, 1,026, or 63 percent, of the unfinished studies hadn’t begun, according to the FDA.

To receive FDA approval, drugmakers often agree to perform additional studies of safety, dosing and other matters after medications come to market. The research is usually voluntary, and lawmakers have repeatedly complained it isn’t completed. President George W. Bush signed legislation in September that allows the FDA to require certain post-approval studies.

``Drugs often come on the market with an expectation that studies will be conducted,’‘ said Peter Lurie, deputy director of the Health Research Group at Washington-based Public Citizen, an advocacy organization, in an interview. ``In fact, many of these studies begin late or do not begin at all.’‘

Doctors say post-approval studies may be needed to fully assess the risks of medications because some dangers don’t emerge until products are in widespread use.

Some research has been pending for years. Of the 1,044 studies that hadn’t begun, drugmakers committed before Oct. 1, 2004, to undertake 444 of them, according to the FDA.

The FDA statistics show 271 studies, or 16 percent, were on or ahead of schedule, and 242, or 14 percent, had been submitted for FDA review or terminated before completion. The FDA described 125 studies as ``delayed.’‘

Not all of the uninitiated studies are considered late by the FDA. Many don’t have deadlines imposed by regulators.

Industry, FDA Comments

Studies can take a long time to begin because of discussions with the FDA over how they should be conducted and difficulties enrolling patients, said Alan Goldhammer, deputy vice president for regulatory affairs at the Pharmaceutical Research and Manufacturers of America, an industry group in Washington.

The FDA is considering how to ``integrate’‘ its new power to require studies with commitments that have been made by drugmakers, said agency spokeswoman Susan Cruzan.

The FDA will work to ensure that studies previously promised ``are completed in a timely manner,’‘ Cruzan said in an e-mail.

The FDA didn’t specify the number of drugs covered by the studies. Drugmakers sometimes agree to complete multiple studies for a single product.

The FDA’s annual report on outstanding post-approval studies doesn’t identify specific companies.