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March 30— The final set of bills to culminate a yearlong Senate effort to spur new medical treatments has been posted ahead of the Senate health panel's April 6 markup.
In a markup notice published March 30, the Senate Health, Education, Labor and Pensions Committee posted five bills on issues ranging from antibiotics, the workforce at the NIH and FDA and precision medicine to the promotion of biomedical research.
The April 6 markup is expected to be the final of three sessions held by the HELP Committee on an effort to accelerate the development of new drugs and devices. As the companion effort to the House-passed 21st Century Cures bill (H.R. 6), HELP Chairman Lamar Alexander (R-Tenn.) has characterized the legislative initiative as “the most important bill signed into law this year,” if it's enacted.
A Senate aide confirmed to Bloomberg BNA that this is the final set of bills for the April 6 agenda:
The workforce bill (S. 2700), which is designed to make it easier to recruit top scientists to work at the National Institutes of Health and the Food and Drug Administration, had already been part of the April 6 agenda .
The antibiotics bill, which is known as the PATH Act, would permit the FDA to accelerate an antibacterial drug's approval for an identifiable, limited patient population if the drug treats a serious or life-threatening condition and addresses an unmet need .
The precision medicine bill would support the White House's ongoing Precision Medicine Initiative to advance an emerging model of health-care delivery that targets treatments to patient subgroups identified by their genetic makeup .
There are no bill numbers or text for the strategic plan or promoting biomedical research bills. However, the NIH released its first-ever agencywide strategic plan this past December that set goals to make significant strides in flu and HIV vaccines, cancer survival rates and diabetes .
HELP so far has approved a total of 14 bills as part of its medical innovation agenda. The first seven bills moved forward during a markup held in February and another seven in March .
However, the committee hasn't resolved the main sticking point of how to pay for these programs. HELP Democrats, particularly ranking member Sen. Patty Murray (D-Wash.) and Sen. Elizabeth Warren (D-Mass.), have made it clear they won't support the medical innovation legislative package without mandatory funding for the NIH and the FDA. Republicans are more hesitant to use a mandatory funding stream, but Alexander said he's open to a short-term “surge fund” to pay for specific projects such as precision medicine. Alexander said he wants to work out the funding portion on the Senate floor as a separate but related legislative effort.
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More information on the April 6 markup is available at http://1.usa.gov/1MTvNsO.
The workforce bill is at https://www.congress.gov/bill/114th-congress/senate-bill/2700; the precision medicine bill is at https://www.congress.gov/bill/114th-congress/senate-bill/2713; and the PATH Act is at https://www.congress.gov/bill/114th-congress/senate-bill/185.
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