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Q: Do clinical trials ever go wrong?

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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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 Subject :FDA Slow to Debar Doctors Who Commit Crimes .. 2009-10-23 15:02:58 
Savitha
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Joined: 2009-07-24 14:37:58
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Dear All,

The Food and Drug Administration is slow to debar health professionals who have been convicted of crimes from doing research for the agency or overseeing the safety of patients in clinical trials, according to a government watchdog report released Thursday.

In one instance, it took the FDA 11 years to debar a doctor who had been convicted of 53 counts of criminal offense for, among other things, bribing an employee to conceal information about the attempted suicide of a clinical-trial patient and prescribing a drug without a license.

The FDA has the authority to bar doctors from overseeing the safety of patients in clinical trials if those health professional flout federal regulations. The FDA is required to disqualify doctors who are convicted of fraud or other crimes. However, it takes the agency an average of four years to strip doctors of their powers, according to a report by the independent Government Accountability Office.

Types of misconduct that can get doctors debarred include submitting false information to the FDA, forging patient consent forms and not reporting when a patient has an adverse reaction to an experimental drug.

The FDA said, in a response to the GAO, that it has tightened its debarment proceedings over the last several years and has established rigid deadlines to ensure health professionals who break the law get quickly stripped of their powers. The agency has also added extra staff to deal with these issues.

The report also shows that even when the FDA bars a doctor from participating in a clinical trial for a drug, that person can still oversee patients in experimental trials that involve medical devices. The process also works the other way: A doctor barred from overseeing trials involving medical devices can still participate in drug trials.

Further, the FDA doesn't have the authority to debar doctors, regardless of their misconduct, from participating in any form of the medical-device industry. The report says a health professional who was convicted of falsely advertising a laser device for treating eye disorders can't be debarred.

It's this loop hole and the FDA's slow response that Republican Rep. Joe Barton of Texas, hopes to close with a proposed bill that would require the FDA to debar doctors within one year of their being convicted of a crime or found committing fraud.

"I think it is especially inexcusable that the agency can't seem to quickly and consistently debar even convicted felons," Mr. Barton said in a press release.

Mr. Barton highlighted what he calls a "notorious" case. It took the FDA about five years to debar Anne Kirkman-Campbell, an Alabama physician who pled guilty to mail fraud and was sentenced to more than four years in jail related to a clinical trial for Sanofi-Aventis SA's antibiotic, Ketek.

The GAO says it recommends that the FDA be given debarment authority for medical devices, and that regulations be rewritten so any doctor debarred from one area of agency regulation is barred from participating in all others. The report notes that three doctors who either didn't follow FDA regulations or committed crimes still haven't been debarred. One of the cases stretches back to 2005.

Regards

Savitha
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Regards

Savitha:) :star:
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