Senate HELP Committee advances seven bills as counterpart to 21st Century Cures
- The Senate's Health, Education, Labor & Pensions (HELP) committee advanced seven bills during a mark-up session yesterday as it works on counterpart legislation to the House’s 21st Century Cures Act.
- Included among the seven bills was legislation which would reauthorize the rare pediatric disease priority review voucher (PRV) program through 2022.
- In a report last week, the Government Accountability Office indicated the FDA opposes renewal of the pediatric PRV, which is set to expire on October 1, 2016. The drug regulator is concerned the program requires the agency to award priority reviews to new drugs which wouldn’t otherwise qualify.
The normally more bipartisan HELP committee has recently been divided over how to proceed with 21st Century Cures legislation. Republican and Democrat members have been split over funding for the FDA and the National Institutes of Health, as well as over reforms to the FDA’s approval process.
Democrats have proposed $5 billion in new funding for the NIH and the FDA, in part to provide money for Vice President Joe Biden’s Cancer MoonShot and the Obama administration’s Precision Medicine Initiative. Republicans also support funding these projects, but at lower levels.
Yesterday’s mark-up was the second of three sessions aimed at building legislation to match the House’s 21st Century Cures Act. Seven total bills were advanced, five of which were passed by voice vote.
However, reauthorization of the pediatric PRV as well as adding the Zika virus to the Tropical Disease list sparked sharper discussion.
Senator Susan Collins (R-ME) expressed her concern companies can buy compounds to qualify for the tropical disease PRV program without doing any real research, RAPS reports. She has introduced a bill to close this loophole but the HELP committee did not change the structure of the tropical disease program.
Doctors Without Borders has been vocal in advocating for changes to this program, arguing it rewards companies who have not actually created a new drug. “By adding Zika to the list for which companies can receive a PRV without first ensuring that the program rewards true innovation and that the people most in need benefit from any scientific breakthrough, we are repeating our mistakes,” said the organization in an e-mailed statement.
- Regulatory Affairs Professional Society Senate HELP Advances Bill to Reauthorize Pediatric PRV Program and Six Other Bills