Senate HELP Advances Bill to Reauthorize Pediatric PRV Program and Six Other Bills

Regulatory NewsRegulatory News
| 09 March 2016 | By Zachary Brennan 

The Senate Health, Education, Labor & Pensions committee on Wednesday advanced seven bills, including one that would reauthorize the rare pediatric priority review voucher (PRV) program through 2022, and one bill that would add the Zika virus to the tropical disease PRV program.

The advancement of the bill sponsored by Sen. Bob Casey (D-PA) to extend the pediatric PRV program comes as the US Food and Drug Administration (FDA) told the Government Accountability Office (GAO) last week that it does not support the program’s reauthorization as the current program is set to expire 1 October 2016. The GAO said it’s too early to decide if the program is effective.

FDA expressed concern that the program adversely affects the agency’s ability to set its public health priorities.

Casey, however, told his colleagues that the PRVs “foster innovation” and because they can be sold on the open market, companies often spend the money earned from selling a PRV on additional research. However, no company that has sold a PRV has disclosed how it has spent those funds and there is no provision in the reauthorization bill that would shine new light on how companies spend what they make from the PRV program.

PRV Concerns

Casey also raised some concerns about the PRV program, particularly as some companies develop targeted therapies and could end up winning multiple PRVs for “sequentially targeted therapies for one disease,” which could “lessen the value of the vouchers.”

Sen. Susan Collins (R-ME) also raised concerns about a loophole in the tropical disease PRV program that allows companies to buy compounds and win PRVs even though they have not conducted the research.

Doctors Without Borders (MSF) has also been vocal about closing this loophole.

“The PRV is rewarding companies without helping to stimulate development of urgently needed new products for neglected diseases and make them available and affordable for patients,” MSF said.

The group also notes that a PRV has sold for $350 million, which is three and a half times the total amount of money the US government committed to neglected tropical diseases in FY 2015. In November, MSF sent a letter calling on the Senate to make changes to the program.

Sen. Claire McCaskill (D-MO) and Collins have introduced a bill that would close this loophole and also create a new PRV program for generics.

Sen. Al Franken’s (D-MN) bill to add the Zika virus to the tropical disease PRV program advanced on Wednesday and Sen. Richard Burr (R-NC) criticized HHS Secretary Sylvia Burwell for not adding Zika to the tropical disease program, which she can do via an order thanks to the law from 2014 that added Ebola to the program.

Other Bills

In addition to the bills dealing with the PRV programs, the Senate HELP committee advanced by voice vote several other bills without much discussion, including:

  • S. 1077, The Advancing Breakthrough Medical Devices for Patients Act of 2015, which would prioritize FDA’s review of breakthrough medical devices 
  • S. 1101, The Medical Electronic Data Technology Enhancement for Consumers Health Act
  • S. 2055, The Medical Countermeasures Innovation Act of 2015
  • S. 1767, The Combination Products Innovation Act of 2015
  • S. 1597, Patient Focused Impact Assessment Act of 2015

The bills are part of the Senate’s piecemeal approach to providing companion legislation to the House-passed 21st Century Cures Act, which Sen. Lamar Alexander (R-TN) made clear on Wednesday no longer would work as passed because all of the “pay-fors” included in the House legislation “were stolen in the omnibus.”

The advancement of these bills also comes as the HELP committee last month pushed seven other bills out of committee.

Mandatory Funding

Meanwhile, Sen. Elizabeth Warren (D-MA) withdrew an amendment, which was first proposed as a bill that all Democrats on the committee supported, that would’ve added permanent additional funding to the National Institutes of Health and FDA.

Alexander said the “best way to support NIH is by steady increases and appropriations,” while Sen. Mike Enzi (R-WY) added that FDA funding has seen substantial increases through additional user fees.

Alexander also said the committee will continue to work to reach bipartisan agreement on a short-term surge of mandatory funding to boost high-priority research projects, like the president’s Precision Medicine Initiative and the Cancer “Moonshot” program, at NIH.


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