Senate Panel Approves ‘Cures'Bills, Sets Stage for Floor Action

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By Jeannie Baumann

April 6 — A Senate committee approved five medical innovation bills April 6 during the final markup of companion legislation to the House's 21st Century Cures bill.

The five bills—which include language to deter the FDA from relying too heavily on guidance documents and to address privacy protection for research participants' genetic data—are the last bills the Senate Health, Education, Labor and Pensions Committee will mark up in an effort to accelerate the development of new drugs and devices. The committee has now approved a total of 19 bills with 50 proposals over three markup sessions as part of the legislative package.

However, HELP Committee Chairman Lamar Alexander (R-Tenn.) said the Senate still has more work to do, most notably reaching a bipartisan agreement on mandatory funding for the National Institutes of Health

“The House has done its job. We’ve done most of ours,” Alexander said, reiterating statements that the medical innovation effort is the most important legislation that can move through Congress this year. “It has the promise of improving the health of virtually every American. We should make certain we finish this, and the sooner the better.”

The House approved its cures measure, H.R. 6, in 2015.

Floor Action Next

Senate Majority Leader Mitch McConnell (R-Ky.) has agreed to hold a floor vote on 21st Century Cures once the HELP committee has completed its work, Alexander said.

The committee has made progress on the issue of mandatory NIH funding, Alexander said, adding that the House's bill would provide $8.75 billion in mandatory funding for both the NIH and the Food and Drug Administration.

HELP Democrats, particularly Sens. Elizabeth Warren (Mass.) and ranking member Patty Murray (D-Wash), have said they won't support the medical innovation package without additional, mandatory NIH funding. Alexander said he favors a one-time funding surge to support specific projects in precision medicine, the cancer “moonshot” initiative, brain research, support for young scientists and big “biothink” awards for large, innovative projects.

“I can assure that you I don’t have any intention of taking the work product of this committee to the floor without a bipartisan agreement with Senator Murray and others about the surge of funding for the National Institutes of Health,” Alexander said. “Without that agreement, we don’t get this bill. But without this bill, we don’t get mandatory funding either.”

HELP Committee leaders have consulted with the chairman and ranking member of the Senate Finance Committee as well as Health and Human Services Secretary Sylvia Mathews Burwell, he said.

Murray said she believes the committee can reach a bipartisan agreement, and once that's reached, “we'd be able to make a real difference in the lives of patients and families across the country.”

Besides funding, Alexander said, other issues that still need to be resolved are:

  • appropriate language for regenerative medicine legislation;
  • monitoring medical devices after they’re approved, an issue for which Murray has advocated strongly;
  • a rare-disease or orphan drug bill (S. 1421) known as the OPEN Act, which would extend the exclusivity period by six months on an FDA-approved drug or biological product that is approved to prevent, diagnose or treat a new indication for a rare disease or condition; and
  • oversight of laboratory-developed tests, an area where the FDA has proposed taking a stronger role.

    “These are some of the remaining issues, but the fact remains that we began with 50 bipartisan issues,” Alexander said. “So we’ve made substantial progress.”

    Bills Approved

    The bills approved by the committee during the April 6 markup were:

  • S. 2700, the FDA and NIH Workforce Authorities Modernization Act, which is designed to make it easier for the NIH and the FDA to recruit top scientists;
  • S. 185, the Promise for Antibiotics and Therapeutics for Health (PATH) Act, which 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;
  • S. 2713, the Advancing Precision Medicine Act of 2016, which supports 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;
  • S 2742, the Promoting Biomedical Research and Public Health for Patients Act, which aims to cut the time scientists spend on administrative tasks so they can focus more on developing medical treatments; and
  • S. 2745, the NIH Strategic Plan and Inclusion in Clinical Research.

    Four of the five bills moved forward on a voice vote. Senators approved the precision medicine bill (S. 2713) by a 20-2 vote, with Warren and Sen. Rand Paul (R-Ky.) voting against the bill.

    Too Many FDA Guidances?

    The HELP Committee also approved several amendments to the bills, including one from Sen. Pat Roberts (R-Kan.) over concern that the FDA is relying too heavily on guidance documents instead of using the rulemaking process. Roberts' amendment would require the FDA to justify why it's issuing a guidance document as opposed to formal rulemaking, whenever the FDA issues a new guidance that provides initial interpretations of new significant regulatory requirements.

    The committee approves an amendment requiring the FDA to justify why it's issuing a guidance document as opposed to formal rulemaking in certain cases.

    “My intent is not to prohibit the agency from issuing guidance. They aren’t all bad. They are vital to industries the FDA regulates,” Roberts said. “But they must be used appropriately—to guide, not to implement new policies and avoid the requirements of the formal rulemaking process.”

    Murray said she couldn't support Roberts' amendment because FDA Commissioner Robert M. Califf expressed concerns that such a requirement would slow the FDA's ability to relay information quickly and efficiently, especially when there is a public health risk.

    The FDA guidance language was one of two amendments HELP members attached to S. 2700. The other amendment from Sens. Richard Burr (R-N.C.) and Robert P. Casey Jr. (D-Pa.) would waive the Department of Health and Human Services' requirements under the Paperwork Reduction Act during a public health emergency.


    The committee also approved an amendment to S. 2713 to protect the genetic privacy of research participants. Warren, who sponsored the amendment with Sen. Michael B. Enzi (R-Wyo.), said the privacy laws need to be updated as researchers are collecting more and more information to help understand diseases and develop the next generation of cures.

    “It will give more people reassurance that participation in clinical trials won’t compromise their privacy,” she said.

    Warren, who has said she won't vote in favor of any medical innovation bills without guaranteed mandatory funding for the NIH, voted in favor of the amendment but against S. 2713.

    The committee also approved an amendment to S. 2742 from Burr that would require the NIH's National Center for Advancing Translational Sciences to include in its annual report any methods and tools that have been developed with NCATS-supported research.

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

    To contact the editor responsible for this story: Brian Broderick at

    For More Information

    More information on the markup is available at

    Warren and Enzi's genetic privacy amendment is at

    Roberts' amendment on FDA guidance is at

    Burr's NCATS amendment is at

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