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Bloomberg BNA – Senate HELP Releases First Bill for Final ‘Cures' Markup

Bloomberg BNA – Senate HELP Releases First Bill for Final ‘Cures' Markup

A bipartisan bill designed to make it easier for the NIH and the FDA to recruit top scientists was introduced in the Senate March 17.

The Food and Drug Administration and National Institutes of Health Workforce Authorities Modernization Act is the first bill announced for consideration April 6 when the Senate Health, Education, Labor, and Pensions Committee is expected to wrap up its work on medical innovation legislation to accelerate the pace of new medical treatments. The April 6 markup is expected to be the last of three mark-up sessions that HELP will have convened this year in the companion effort to the House-passed 21st Century Cures bill (H.R. 6). The committee said in a March 17 statement that it will release the final set of bills at a later date.

“There has never been a more remarkable time in biomedical innovation and research,” HELP Chairman Lamar Alexander (R-Tenn.) said in a March 17 statement. “This bipartisan bill takes a significant step to improve FDA and NIH’s ability to deliver on the promise of this exciting time in science, by helping them hire and retain top performers and cutting red tape that actually obstructs their ability to keep up with the newest scientific advancements.”

The bill also would facilitate collaborations between government and the medical industry and remove administrative requirements to justify travel to scientific meetings, a process that NIH Director Francis S. Collins told senators has cost the agency $14.5 million to implement. The travel justification requirements, he told HELP members last year, has created obstacles in promoting scientific discourse without adding any beneficial oversight.

Bill Highlights

The bill would:

  • enable the FDA to participate more fully in the Senior Biomedical Research Service, a program used primarily at the NIH for scientists who are considered by their peers to be outstanding in their work, and expand the limit on eligible members from 500 to 2,000;
  • allow the FDA to offer salary compensation that is more competitive with the private sector for top scientists;
  • allow the FDA to conduct a pilot program to test the best ways to boost communication between different centers at the agency;
  • remove the aforementioned travel justification requirements for both the FDA and the NIH;
  • change the Reagan-Udall Foundation, a nonprofit organization established by Congress to promote regulatory science, to allow FDA advisory board members to serve on the foundation’s board; and
  • exempt from the Paperwork Reduction Act NIH research that relies on voluntary data collection, a requirement the committee described as duplicative.

Sen. Patty Murray (D-Wash.), the top Democrat on the HELP panel, said the bill would allow both the NIH and the FDA to keep the best researchers, doctors and scientists on staff, while breaking down barriers that may impede important collaboration.

“With so many patients and families waiting and hoping for new, safe, effective cures and treatments, we should absolutely work to strengthen hiring practices and break down siloed research that get in the way of innovation,” Murray said.

Mandatory Funding Comes Up Again

The main sticking point in an otherwise bipartisan process is whether the medical innovation initiative should include mandatory funding for the NIH and the FDA. Murray has been clear about her support for mandatory funding for both agencies, a point she reiterated when announcing the bill.

“I’m very hopeful that we can continue working in a bipartisan way to agree on strong mandatory investments in the NIH and the FDA as well as policies to strengthen patient and consumer safety—each of which, as Democrats have made clear, are necessary to reach a final agreement,” she said.

Alexander has previously said he is open to an Innovation Surge Fund that would provide mandatory funding for specific initiatives at the NIH, such as the cancer “moonshot” and precision medicine initiatives. The final medical innovation package is expected to include about 30 bills with more than 50 proposals. The HELP committee approved seven bills during a February markup , and seven more in March .

The advocacy group Friends of Cancer Research applauded the bill, which the group said in a March 17 statement incorporated their proposal for an Oncology Center for Excellence through the bill’s interagency pilot program.

“By investing in the agency and by incorporating our proposal for Centers of Excellence, this legislation will be able to enhance the FDA’s ability to execute their vital role in translating scientific discovery into new therapies for patients,” Ellen Sigal, Friends’ chairwoman and founder, said in a statement.