A recently released report has found that the U.S. Food and Drug Administration (FDA) does not move as quickly as it could in banning health professionals from drug research roles who are known to have convicted crimes, the Wall Street Journal just reported.
In one of the cited cases, the agency took 11 years to debar a physician criminally convicted 53 offenses, including “bribing an employee to conceal information about the attempted suicide of a clinical-trial patient and prescribing a drug without a license,” said the Journal. Unbelievably, the agency does have authority to ban doctors from patient safety overview in clinical trials when those doctors break or ignore federal regulations, said the Journal. Moreover, the agency is mandated to debar or disqualify those doctors who have been committed crimes such as fraud, reported the Journal. The Government Accountability Office (GAO) issued the report.
Physicians can be debarred from working with the FDA for a variety of types of misconduct, including providing bogus information to the agency, “forging patient consent forms,” and not reporting adverse reactions to experimental medications, said the Journal. In response to the report, the agency said it has strengthened its procedures, including implementing tighter deadlines and hiring additional staff.
But, debarment does not always eradicate the issue and, as Modern Healthcare pointed out, even when debarment was timely, a loophole in the process does not enable the FDA to ban lawbreakers who work in medical device investigations. For instance, following FDA debarment, a doctor can still have patient oversight responsibilities in medical device trials, and vice versa said the Journal, in part because the FDA does not have authority over physicians participating in the medical device industry. Citing the report, the Journal pointed out that a health professional who was convicted of “falsely advertising a laser device” for the optical field has not and cannot be debarred by the FDA.
In another stunning case, Representative Joe Baron (Republican-Texas) discussed how the FDA allowed five years to pass before debarring Alabama doctor, Anne Kirkman-Campbell, said the Journal. Kirkman-Campbell pled guilty to mail fraud and received a four-year sentence for her part in crimes related to a Sanofi-Aventis SA clinical trial for Ketek, an antibiotic. Barton, who described the case as “notorious,” is working on a proposed bill to require the agency to debar doctors no later than one year following conviction of a crime or being found committing a fraud. “I think it is especially inexcusable that the agency can’t seem to quickly and consistently debar even convicted felons,” said Barton, quoted the Journal.
The GAO is recommending the agency receive debarment authority for medical devices and that there exists a crosscheck between regulations to prohibit a doctor debarred from one area from contributing in another area, such as between medicines and medical devices, said the Journal. “The FDA had failed to make its debarment authority work, and now the GAO report offers the latest detail of a record of the agency’s weakness and failures,” said Barton, quoted Modern Healthcare.
Sadly, according to the GAO report, there are still three doctors who have not been debarred, but who are known to have ether committed crimes or ignored FDA regulations, once case going back four years, said the Journal.