Senate passes FDA user fee reauthorization

Senate passes FDA user fee reauthorization

By an easy vote of 94-1, the Senate passed the FDA Reauthorization Act (FDARA) of 2017, approving the user fee agreements paid by pharmaceutical and medical device companies to the Food and Drug Administration.

The House had passed the bill with similar support in July, with the Senate schedule initially unclear as the chamber focused its attention on attempts to repeal and replace the Affordable Care Act. The FDA had warned of layoffs it wasn’t enacted quickly, as the agency’s authority to collect user fees from the companies it regulates was due to expire at the end of September.

“Working together, House and Senate Republicans and Democrats brought forth a bill to reauthorize these important programs, putting patients first and their hope for new treatments within reach,” said Energy and Commerce Committee Chairman Greg Walden, R-Oregon, Energy and Commerce Committee Ranking Member Frank Pallone, Jr., D-New Jersey), Health Subcommittee Chairman Michael C. Burgess, MD. R-Texas,and Health Subcommittee Ranking Member Gene Green, D-Texas, in a joint statement. “This bill is a win for patients and the millions of Americans working to develop our next generation of cures and therapies. We applaud the Senate’s swift action in passing this vital bill, and urge President Trump to sign it into law.”

The legislation didn’t match what President Donald Trump proposed. His 2018 budget proposal called for doubling FDA user fees to $2 billion, even after several years of increases since the fees were last negotiated in 2012.

After the House vote, the White House urged Congress “to provide for 100 percent user fee funding within the reauthorized programs. In an era of renewed fiscal restraint, industries that benefit directly from FDA’s work should pay for it.” However, statement didn’t say Trump may veto the legislation if those changes weren’t made.

The bill has been praised by the Medical Imaging & Technology Alliance (MITA) for clarifying the FDA’s authority on reviewing and clearing new indications for imaging device manufacturers. The legislation would also require the FDA to produce, within 270 days of being signed into law, a report on device servicing quality and safety, which MITA said would address risks created when unregulated, third-party groups service devices improperly.

“As the bill moves to the White House for signature, we applaud the bipartisan efforts of the House and Senate to find reasonable, common-sense solutions to clear regulatory hurdles that hinder medical innovation and ensure patient access to life-saving technology,” Joe Robinson, chairman of the MITA board of directors and senior vice president of health systems solutions at Philips Healthcare, said in a statement to HealthExec.