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Regulatory News | 06 April 2016 | By Zachary Brennan
The Senate Health, Education, Labor & Pensions Committee on Wednesday advanced five more bills to the Senate floor for discussion as part of a series of 19 companion bills to the mammoth House-passed 21st Century Cures bill.
Wednesday marked the third and final hearing by the committee, which is still grappling with a fight over $50 billion in additional mandatory funding for the National Institutes of Health (NIH) that’s supported by Senate Democrats.
“With its 21st Century Cures Act, the House voted 344 to 77 to provide $8.8 billion in paid-for mandatory funding to support such NIH priorities. We continue working on finding an amount that the House will agree to and the president will sign that we can responsibly pay for in a bipartisan way,” Chairman Lamar Alexander (R-TN) said.
In February and March, the committee advanced bills dealing with a wide range of issues that will have a major impact on how the US Food and Drug Administration (FDA) regulates medical devices, drugs and drug-device combination products, including:
Sen. Al Franken's (D-MN) bill to add the Zika virus to the tropical disease priority review voucher program was also considered one of the companion bills to the House-passed Cures legislation, though that bill has already won Senate approval.
The bills advanced by voice vote on Wednesday include one that helps FDA and NIH attract top new talent, which newly confirmed FDA Commissioner Robert Califf has said is a priority for his agency.
Other bills include:
Although FDA is likely to view the whole package of bills as favorable, the agency may take issue with an amendment from Sen. Pat Roberts (R-KS) on the precision medicine bill that would require FDA to explain why it’s using a non-binding guidance document rather than a rule in each new guidance document issued.
Roberts explained that FDA has issued more than 600 guidance documents since 2007, though these documents are supposed to be issued only to clarify regulations, not to establish new policies.
Sen. Patty Murray (D-WA) opposed the amendment and said that she spoke to Califf, who told her that the guidance documents are necessary for the agency to keep industry updated on ongoing work.
“Califf is concerned this would throw sand into the gears of FDA’s public health work,” Murray said, though the amendment was approved by voice vote. The only additional amendment that passed was one from Sens. Elizabeth Warren (D-MA) and Mike Enzi (R-WY) to add more patient protection rights under the precision medicine initiative.
Warren also made clear that she does not support moving forward on the package of bills until more NIH mandatory funding is established.
“We will lose a generation of scientists because Congress refused to fund their work,” Warren cautioned.
Tags: Senate companion bills to Cures, 21st Century Cures, Senate Medical Innovation, Senate HELP