Senate Bill to Reauthorize FDA’s Drug, Device User Fees Advances


The Senate health panel voted 21-2 to approve legislation to reauthorize the FDA’s user fee programs May 11, after a one-day delay.

The Senate Health, Education, Labor and Pensions Committee had been scheduled to vote on the bill (S. 934) May 10, but the vote was delayed because Senate Democrats were meeting to discuss the firing of FBI Director James Comey. The bill now goes to the Senate floor for consideration.

The current authorization for the user fees expires Sept. 30. The drug and device industries pay user fees to help fund FDA operations. Failure to enact the reauthorization bill this summer would mean the FDA would have to prepare to lay off about 5,000 employees—including 70 percent of the drug review staff.

Two amendments to the user fee bill—which would improve access to generic drugs and improve clinical trials for experimental medical treatments that have life-saving potential—were approved by voice vote.

Sen. Bernie Sanders (I-Vt.) also offered an amendment that would have allowed Americans with valid prescriptions to import prescription drugs from Canada. That amendment was tabled by a vote of 13-10. Drug importation is a controversial issue. While some say it would allow Americans to buy cheaper drugs from Canada, some say it would subject Americans to unsafe or counterfeit drugs.

Bloomberg analyst Brian Rye told me “there haven’t been as many amendments in this reauthorization as there were in previous years, as many of the provisions that would have been added here were included in the 21st Century Cures bill that was signed into law last December.”

“That said, we wouldn’t be surprised to see other items added, particularly around the issue of drug pricing, before a final bill is enacted,” Rye said.

The 21st Century Cures Act (Pub. L. 114-255) is a biomedical innovation law enacted in 2016 to spur new drugs and devices.

Read my full article here.

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