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March 9— A legislative package designed to accelerate the development of new medical products easily moved through a Senate health panel March 9, as Democrats continued pushing for a mandatory funding stream for the NIH and the FDA.
The Senate Health, Education, Labor and Pensions Committee approved seven bills containing 15 proposals on a range of drug and device topics, including combination products, medical devices and incentives for developing a Zika virus vaccine. The markup is the second of three mark-up sessions the committee is holding in a companion effort to the 21st Century Cures bill (H.R. 6) that the House approved last summer .
HELP Committee Chairman Lamar Alexander (R-Tenn.) said that, if enacted, the medical innovation bill would be the most important piece of legislation that moves through Congress this year because it affects virtually every American.
“Everybody wants to take advantage of this remarkable scientific opportunity of biomedical research,” he said.
The seven bills approved in the markup were:
The committee approved six bills on a voice vote. The first bill on the docket, S. 1878, received a 20-2 vote, with Sen. Elizabeth Warren (D-Mass.) voting against the measure along with Sen. Bernie Sanders (I-Vt.), who voted no by proxy.
Warren voted against all the bills because she is holding out for a way to provide mandatory funding for the National Institutes of Health and the Food and Drug Administration.
The issue of mandatory funding dominated much of the discussion during the markup, and it has been an ongoing issue since the House passed its bill with mandatory funding for both agencies. Warren introduced—and immediately withdrew—legislation (S. 2624) that Senate HELP Democrats introduced the week of Feb. 29 which would provide a total of an additional $5 billion a year for both agencies in mandatory spending on top of the regular appropriation .
“Until we have a concrete deal with significant, guaranteed investments for medical research, health innovation legislation will not leave the floor of the Senate,” Warren said.
Referring to the more than 20 percent decline in the NIH's purchasing power since 2003, she added “for more than a decade, Congress has been strangling medical research in this country.”
“We need real medical innovation, and that starts with putting up the money for basic research,” she said.
Alexander said the best way to support medical research is to provide steady increases for the NIH through the annual appropriations process, criticizing President Barack Obama for cutting the NIH's discretionary dollars in the fiscal year 2017 budget request, and replacing that funding with $1.8 billion in mandatory spending for new research grants .
“I think it’s very dangerous to begin to rely on mandatory funding for an essential service like the National Institutes of Health,” he said after the hearing.
Alexander reiterated previous comments that he would support an “innovation surge fund” that would pay for specific projects such as the cancer moonshot and precision medicine initiatives and have a clear sunset.
“I pledge to work with Senator [Patty] Murray (D-Wash.) and other members of the committee to try to achieve a bipartisan consensus that will arrive on the floor at the same time as this innovation package does. I know that innovation is not likely to get 60 votes unless we have some sort of bipartisan way to have a surge of mandatory funding for the National Institutes of Health,” he said in his opening statement. Murray is the HELP Committee's top Democrat.
After the hearing, Alexander told reporters he expects the surge fund only would provide additional money for NIH projects, not the FDA. “FDA’s a different kettle of fish,” he said. “NIH is for research.”
The markup builds on a previous session in February, when the HELP Committee approved bills on health IT, support for young researchers and other measures .
Alexander said the final markup is scheduled for April 6, and he expects the total innovation package to include about 50 different measures. The committee hasn't released the bills to be considered for that markup, but Alexander said they will be out soon. He also said he expects the issue of drug pricing to come up, noting that Sens. Susan Collins (R-Maine) and Claire McCaskill (D-Mo.), the chairwoman and ranking member, respectively, of the Senate Special Committee on Aging, have been investigating rising drug prices. But Alexander said the Aging Committee has no legislative jurisdiction.
“I expect to see a Collins-McCaskill amendment perhaps at the next markup on drug pricing,” he said. “That’d be an appropriate time to deal with it.”
Noting that the appropriations hearings are set to begin April 15, he said he looks forward to wrapping up the innovation work promptly to move both the innovation and surge bills to a floor vote. Lawmakers would like to get the bill enacted by the end of the year.
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More information on the Senate HELP March 9 markup is available http://www.help.senate.gov/hearings/s1878-s1077-s1101-s2055-s1767-s1597-s2512-and-nomination-of-dr-john-king.
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