Senate Panel Approves Zika Measure, Other Innovation Bills

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By Jeannie Baumann

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.

Seven Bills

The seven bills approved in the markup were:

  • S. 1878, the Advancing Hope Act of 2015, which would expand the priority review voucher program for rare pediatric diseases to include treatments for sickle cell disease and pediatric cancers and remove a provision terminating the program.
  • S. 2055, the Medical Countermeasure Innovation Act of 2015, designed to spur the development of drugs, devices and preventive treatments to protect people in the event of a global pandemic or biological weapon attack by establishing, among other incentives, another priority voucher program for developers of medical countermeasure products. The bill also would change language in the Public Health Service Act (42 U.S.C. §§247d–6b(c)) to require, rather than recommend, a special reserve fund to develop these countermeasures.
  • S. 1101, the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act, which would exclude from medical device regulations certain types of software commonly used to run a medical practice—such as software for financial records or for clinical laboratory testing that doesn't analyze test data.
  • S. 1767, the Combination Products Innovation Act of 2015, which would allow the FDA to rely on prior findings of safety and efficacy when deciding whether to approve a combination drug/device product. The bill also would make it easier for the FDA to address whether a product is reviewed as a drug, device or biologic based on the product's primary intended purpose.
  • S. 1077, the Advancing Breakthrough Medical Devices for Patients Act of 2015, which would create a program to expedite review of so-called breakthrough devices, similar to an existing program for drugs.
  • S. 2512, the Adding Zika Virus to the FDA Priority Review Voucher Program Act, which would add Zika to the list of eligible diseases for the FDA priority review voucher program.
  • S. 1597, the Patient-Focused Impact Assessment Act of 2015, which would require the package insert of any approved drugs to explain whether information such as patient preferences and patient-reported or caregiver-reported outcomes were reviewed or examined in the development process.

    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.

    Mandatory Funding Still Key Issue

    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.

    Innovation Surge Fund

    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.”

    Drug Pricing Expected in Final Markup

    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.

    To contact the reporter on this story: Jeannie Baumann in Washington at

    To contact the editor responsible for this story: Nancy Simmons at

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