By Joe Newman
If Health and Human Services (HHS) Secretary Kathleen Sebelius truly wants to make the FDA a “world-class” regulatory agency as she once pledged, she must take seriously the charges of misconduct and mismanagement within the FDA’s Center for Devices and Radiological Health (CDRH).
It has been more than two years since a group of researchers within the CDRH stepped forward to criticize the FDA’s faulty way of reviewing medical devices. They stated that managers, by violating the FDA’s own regulations, were not paying attention to sound scientific advice. By ignoring the advice of its own scientists, the FDA was allowing unsafe medical devices onto the market, they said. Subsequent news articles about faulty devices that have caused needless deaths have backed up their concerns, and the FDA itself even admitted last October that its initial decision to approve one particularly problematic device was driven by political pressure.
According to the whistleblowers, speaking out had its consequences: retaliation by CDRH managers.
In 2009, the HHS Office of the Inspector General took a look at the whistleblowers’ complaints and decided there were no criminal violations. That assessment, however, completely overlooked the possibility of non-criminal misconduct, including violations of federal regulations.
To add insult on top of injury, a follow-up “special inquiry” in fall 2010 initiated by the new Deputy Inspector General, Gerry Roy, concluded that there were no violations of federal regulations. In reaching this conclusion, the investigators apparently looked at little or no new evidence and failed to interview a single whistleblower.
Last week, POGO’s Executive Director Danielle Brian and Staff Scientist Ned Feder wrote Secretary Sebelius and asked her to start her own investigation of the whistleblower concerns.
As noted in their letter, Roy’s failure to conduct a thorough review is a blow to the credibility of both the HHS Office of the Inspector General (OIG) and the FDA.
“We believe it is almost certain that managers in the devices center have committed serious violations of FDA regulations,” Brian said in a statement. “Secretary Sebelius can help restore credibility to the medical devices center by doing what the FDA and Inspector General have failed to do—put the health of the American public first and thoroughly investigate the allegations of mismanagement and wrongdoing.”
Secretary Sebelius can’t let this issue be swept under the carpet. The lives of patients will continue to be put at risk until the FDA’s house is put in order.
Joe Newman is POGO's Director of Communications. Follow Joe on Twitter.
Image by Flickr user US Mission Geneva, used under Creative Commons License.
- The FDA's Deadly Gamble with the Safety of Medical Devices
- POGO's letter to Deputy HHS IG on FDA's CDRH's low standard of medical devices approval
- POGO asks DHHS Secretary Sebelius to reinvestigate FDA's negligent oversight of unsafe medical devices
- POGO's letter to Commissioner Hamburg regarding medical devices
- FDA Administrator Resigns, Challenges Remain