There is growing concern that commercial review boards may too easily accommodate drug and device companies that pay for their services. Some critics also say that companies will shop for an accommodating oversight board after their research plans are rejected by more stringent reviewers.
Over a five-year period, Coast reviewed 356 study proposals and rejected only one, according to data presented at the hearing. Meanwhile, since 2004 the company’s revenue has more than doubled, to $9.3 million in 2008.
In a report presented at Thursday’s hearing, officials of the Government Accountability Office, a research arm of Congress, said they had found that the commercial review system was vulnerable to manipulation. It was G.A.O. investigators who set up the Adhesiabloc sting.
In responding to undercover solicitations from G.A.O. investigators, two other companies — Argus Independent Review Board, of Tucson, and Fox Commercial Institutional Review Board, of Springfield, Ill. — refused to approve the Adhesiabloc plan. In their responses, they called the trial design “awful,” and “a piece of junk,” according to the G.A.O.
After a separate F.D.A. inspection last year, Coast received an agency warning letter after officials discovered it had used an unqualified person to approve an advertisement to recruit trial subjects for a different, real study. That approval had come, the F.D.A. letter said, after qualified reviewers working for Coast had found the advertisement unacceptable.
An F.D.A. official said at Thursday’s hearing that Coast had subsequently submitted a plan to improve its procedures. Mr. Dueber said Thursday that Coast also revised its procedures in response to the G.A.O. investigation.
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Another focus of Thursday’s hearing was whether the F.D.A. and the Department of Health and Human Services, which also has a role in overseeing clinical trials, have been doing their jobs to protect patients.
In another part of the G.A.O. operation discussed at the hearing, investigators last year created a fictitious clinical trial oversight company and registered it with the department.
Representative Joe L. Barton, Republican of Texas, asked at the hearing why federal regulators had not yet put companies like Coast out of business, saying the company ought to be “kicked out of the door.”