By ALICIA MUNDY
A Colorado company caught in a congressional sting operation involving oversight of patient safety during clinical trials will voluntarily halt many of its review operations at the request of the Food and Drug Administration, the FDA said Tuesday.
The company, Coast IRB LLC of Colorado Springs, Colo., approves clinical-trial designs and patient-safety guidelines. Companies and medical institutions are required to have an independent institutional review board, or IRB, give these approvals when they experiment on human subjects.
The stoppage could affect 300 trials involving more than 3,000 researchers and includes work for several major pharmaceutical, biotechnology and medical-device companies, according to the FDA. Many of these companies would have to hire an IRB to replace Coast.
Leslie Ball, director of scientific-investigations compliance in the FDA's drug division, said the agency asked Coast to stop some aspects of its reviews "due to serious concerns the FDA has about Coast's ability to protect human subjects."
The FDA on Tuesday sent the company a formal warning letter about violations of IRB guidelines.
Coast's executives couldn't immediately be reached for comment. The company announced last month that it would temporarily suspend new reviews and begin an internal investigation of potential problems raised by congressional investigators. In an interview in March, Coast Chief Executive Dan Dueber said that Coast had caught the sting itself and was concerned about oddities in the study application before it was contacted by the House committee in March. "The protection of human subjects is a solemn trust at Coast," he said.
The FDA will work with drug and device makers on the problems posed by stopping patient enrollment in trials they have begun, said Dr. Ball. She said the FDA would permit Coast to resume clinical-trial reviews after the agency was assured that all safety standards for human subjects were being followed.
Coast IRB was ensnared by an undercover investigation begun last year in which congressional staff and the Government Accountability Office created a fake medical study of a fake product to see whether for-profit review boards adequately supervise medical trials. Lawmakers had raised concerns over whether IRBs routinely approve medical studies for paying clients and are considering whether to introduce a bill to strengthen IRB regulations.
Companies can't get FDA approval for their drugs and devices without an IRB certifying their clinical trials. About 6,350 IRBs are registered with the Department of Health and Human Services.
Two of Coast's competitors declined to approve a fake study in the congressional investigation. But Coast approved the trial for a make-believe surgical gel called Adhesiabloc that would have involved human subjects. The sting became public in early March and was detailed in a hearing before the House Energy and Commerce Committee on March 26. The story of the fake trial was earlier reported in the New York Times.
In his testimony, Mr. Dueber, called the congressional investigation illegal entrapment.
After the hearing, Coast announced that it would suspend new reviews for 30 days and begin a complete audit of all clinical trials now under its review with an outside consultant. Coast also said it is removing the chairwoman of its board and replacing her with someone with more experience in scientific research and IRBs.
Rep. Bart Stupak, the Michigan Democrat who is chairman of the investigations subcommittee that ran the sting, said in a statement Tuesday, "Today's announcement by Coast and the FDA shows how congressional investigations can result in meaningful changes in corporate behavior."
The ranking Republican on the Energy and Commerce Committee, Rep. Joe Barton of Texas, said, "The news that the crackdowns have begun is especially welcome."
Write to Alicia Mundy at alicia.mundy@wsj.com
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