House Democrats prepare bill to overhaul FDA
Agency scientists say they were "ordered, intimidated and coerced" by managers to modify unfavorable determinations during Bush administration.
As the Food and Drug Administration was skewered once again Thursday, this time by the Government Accountability Office, for failing at nearly every aspect of its mission, a House Democratic aide said House Energy and Commerce Democrats are looking to soon introduce legislation that beefs up the agency's power to police food, pharmaceuticals and medical devices.
What Democrats call the FDA globalization bill has lingered in draft form since April and even the draft was a compilation of measures that had floated around a year prior.
Energy and Commerce Oversight and Investigations Subcommittee Chairman Bart Stupak, D-Mich., said Thursday one change could come in the form of stronger medical-device language, though that would not be until down the road. "There's some horrific things that go on with medical devices," Stupak said.
Earlier this month, a group of FDA scientists wrote to President Obama's transition team a letter similar to one they sent Rep. John Dingell, D-Mich., in October claiming FDA brass interferes with the medical-device review process to push through approvals based on faulty and unethical evidence. Dingell was chairman of the Energy and Commerce panel at the time.
The scientists wrote that "[T]he scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk."
They said they were "ordered, intimidated and coerced" by managers to modify unfavorable determinations.
Democrats are discussing whether to include improvements to the medical-device program in the globalization bill, Stupak said, possibly by amendment later or by introducing a separate bill to strengthen the device review process. He declined to specify what changes could be sought.
Stupak expects to hold hearings to hear from patients and physicians as well as manufacturers and FDA on the device scandal. He said he has had a file open investigating the medical device situation for a year and some of the information might be referred to the Justice Department.
To add credence to the many groups arguing for a globalization bill, GAO bestowed on FDA the distinction Thursday of being one of three issues added to its "high-risk" list for its inability to oversee medical product safety.
Congress' investigative arm releases the list at the start of each Congress to help set the oversight agenda. A total of 30 government programs and operations made the list Thursday.
On FDA, GAO said, "New laws, the complexity of items submitted to FDA for approval, and the globalization of the medical products industry are challenging FDA's ability to guarantee the safety and effectiveness of drugs, biologics, and medical devices. As a result, the American consumer may not be adequately protected from unsafe and ineffective medical products."
GAO has issued numerous reports along with other groups, including FDA's own Science Board, on the agency's inability to protect the nation's food and drug supplies as well as medical devices.