It's an old story at this point: A federal agency within the Bush administration is embroiled in controversy over the manipulation of science. This time a group of scientists and physicians within the Food and Drug Administration has written Congress accusing top FDA officials of misconduct in the approval of medical devices. The scientists warn that unsafe or ineffective devices that were improperly approved may be threatening public safety, and the full extent of the danger may not be known for years.
In a blunt letter to Michigan Democratic Rep. John Dingell, chairman of the House Committee on Energy and Commerce, professionals from the FDA Center for Devices and Radiological Health said that senior managers at the CDRH "ordered, intimidated and coerced FDA experts" into altering their scientific evaluations and conclusions regarding medical devices. The scientists say some within their ranks were told to use unsound evaluation methods and to make safety and effectiveness determinations that violated standards.
The accusation is that senior administrators overrode the judgment of trained experts to benefit manufacturers regardless of the implications for public health. The specific devices at issue weren't disclosed, but medical devices include such things as mobile oxygen tanks, cardiac stents and breast implants.
What makes this more worrisome is that in February the U.S. Supreme Court ruled that for certain medical devices, FDA approval prohibits patients from bringing state product liability lawsuits. The case involved a balloon catheter that burst during an angioplasty. The justices ruled that the device's manufacturer could not be sued in state court because federal law pre-empted state law once the device had gone through FDA testing.
But injured patients may be left without recourse if the FDA is skewing some of its approvals to advance the interests of device makers — and the letter alleges there were reprisals for those at the agency who objected. The committee has launched an investigation, and that investigation should continue under the committee's incoming chairman, Rep. Henry Waxman, D-Calif. Ultimately, problems like these are grounded in an antiregulatory mind-set in Washington, and that mind-set is about to change.