Schwitzer health news blog

Drug companies' 1,044 broken promises

Bloomberg News reports:

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.

So don't be surprised when you hear the next news about a "blockbuster" drug that is found to have "surprise" side effects months or years after it's been on the market.