FDA takes action against firm in human experiments

Citing serious violations uncovered by a congressional probe, federal regulators Tuesday imposed restrictions on a company that monitors testing of experimental drugs and medical devices on human beings.

The Food and Drug Administration sent a warning letter to Coast IRB, saying regulators identified "serious violations" of federal rules that protect human subjects, and are concerned about risks to patients. The Colorado Springs, Colo., firm agreed to stop reviewing new experiments and also halt enrollment in research trials already under way.

Independent, expert review of clinical trials is an integral part of the development of new drugs. But a congressional hearing last month exposed flaws in the system. Undercover investigators for the Government Accountability Office were able to get Coast IRB's approval for a fictitious testing protocol that supposedly involved pouring a liter of a product into a woman's stomach following surgery. Two other companies approached by GAO rejected the proposal.

The FDA's action will affect some 300 human studies involving about 3,000 researchers. Coast IRB will have to show regulators it is fully complying with all rules that govern experiments on humans before the restrictions can be lifted.

Coast IRB did not respond immediately Tuesday to a request for comment. In the past, company officials complained the firm was "hoodwinked" by investigators, but said they have since made changes.

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On the Net

FDA announcement: http://tinyurl.com/c83hfu