House passes FDA user fee reauthorization, Senate schedule unclear

The House has passed legislation to reauthorize user fee programs through the Food and Drug Administration (FDA) affecting medical devices, prescription and generic drugs.

Without the bill being signed into law, the FDA’s authority to collect user fees from companies it regulates would expire at the end of September. The agency has warned that unless its enacted by the end of July, it would need to lay off thousands of FDA employees. The bill had enough support in the House to pass by voice vote.

“This bipartisan work has produced a big win for patients,” said House Energy and Commerce Committee Chairman Greg Walden, R-Oregon, said in a statement. The bill “will help bring lower-cost generic drug alternatives and biosimilars to market faster – increasing competition and lowering drug costs – and it will streamline the process for reviewing and approving new treatments and cures for patients, ultimately delivering new and innovative therapies, drugs, and devices to patients more quickly.”

The passage was also praised by FDA Commissioner Scott Gottlieb, MD. The Medical Imaging and Technology Alliance (MITA) was also pleased, which supported the FDA’s continued authority on new indications for imaging device manufacturers and the provision requiring a report on quality and safety of devices.

“The medical imaging community has long advocated for enhanced predictability, consistency, transparency and timeliness of the agency’s pre-market approval and clearance process for medical imaging technologies and other devices,” said Joe Robinson, chairman of the MITA board of directors and senior vice president of health systems solutions at Philips Healthcare. “MITA and its members believe that all MDUFA commitments should be backed by appropriate, measurable and predictable performance goals that support these principles.”

When the Senate will take up the bill is unclear. As explained by Washington University professor Rachel Sachs, JD, MPH, in Health Affairs, Senate Republicans haven’t scheduled a vote on the legislation as they focus on efforts to repeal and replace the Affordable Care Act.

“It would be a shame if the collaborative, bipartisan reauthorization of the FDA’s funding were jeopardized and career public servants fired because (Senate Majority Leader Mitch) McConnell has chosen to prioritize partisan bickering on health care reform. It is the Senate’s choice to continue working on Affordable Care Act repeal to the exclusion of all else,” Sachs wrote.