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Learn about policy issues important to medical schools and teaching hospitals, with Executive Vice President Atul Grover, M.D., Ph.D.

Washington Highlights

Authorizers Seek Input on NIH Legislation; Proposals to Increase Agency’s Budget Emerge

January 30, 2015— The House and Energy and Commerce and Senate Health, Education, Labor, and Pensions (HELP) committees released draft documents seeking public comment on plans to accelerate the delivery of drugs and devices to patients. Meanwhile, several leading Members of Congress introduced legislation to supplement funding for the National Institutes of Health (NIH).

The House Energy and Commerce Committee Jan. 27 released an initial discussion draft outlining some specific legislative proposals arising from the 21st Century Cures initiative, which included five white papers and eight hearings, and a number of roundtable discussions convened in Washington and across the country.

The committee is seeking feedback on the proposals outlined in this document, and envisions an aggressive schedule to introduce 21st Century Cures legislation and ultimately send a bill to President Obama’s desk for signature by the end of the year.

The draft focuses heavily on the Food and Drug Administration (FDA), but contains proposals related to NIH, including:

  • requiring NIH to issue a strategic plan;
  • establishing a program at NIH to help young emerging scientists;

  • requiring NIH to support projects that pursue innovative approaches to major challenges in biomedical research that are high-risk, but have the potential to lead to breakthroughs;

  • establishing a working group composed of NIH and stakeholders to provide recommendations on how to streamline the grant process for researchers; and

  • requiring the Secretary of Health and Human Services (HHS) to develop a plan to carry out a longitudinal study designed to improve the outcomes of patients with chronic disease.

The draft proposal also would help streamline the institutional review board (IRB) process, particularly for clinical trials conducted at multiple sites, by minimizing regulatory duplication and unnecessary delays.

In addition, the draft bill would clarify that peer-reviewed journals, journal reprints, journal supplements, and medical textbooks are excluded from the reporting requirement under the Sunshine Act.

In the Senate, HELP Committee Chair Lamar Alexander (R-Tenn.) and Sen. Richard Burr (R-N.C.) Jan. 29 released a report  on the challenges to getting safe treatments, devices and cures to patients more quickly and effectively, examining what is working, and what is not, at FDA and NIH.

The senators are soliciting feedback on their report as Chairman Alexander and Ranking Member Patty Murray (D-Wash.) begin a major initiative in the Senate HELP committee —including a bipartisan working group and a series of hearings—to examine the time and cost currently involved with the drug and medical device discovery and development process, and how to better align public policies to support medical innovation.

The senators requested feedback on the report by Feb. 23. Ideas should be sent to Innovation@help.senate.gov.

As those initiatives proceed, other members of Congress have introduced legislation focused specifically on research funding.

Sen. Dick Durbin (D-Ill.) Jan. 28 reintroduced the American Cures Act (S. 289) to support research at the NIH, the Centers for Disease Control (CDC), the Department of Defense Health Program (DHP), and the Veterans Medical and Prosthetics Research Program.

The American Cures Act would provide a steady growth rate in federal appropriations for biomedical research conducted at NIH, CDC, DHP, and the Veterans Medical and Prosthetics Research Program. Each year, the bill would increase funding for each agency and program at a rate of GDP-indexed inflation plus 5 percent. Durbin first introduced this legislation during the 113th Congress [see Washington Highlights, March 14, 2014].

Sens. Sherrod Brown (D-Ohio), Amy Klobuchar (D-Minn.), Barbara Boxer (D-Calif.), Edward J. Markey (D-Mass.), Ben Cardin (D-Md.), Al Franken (D-Minn.) and Bob Casey (D-Pa.) are original cosponsors of the bill.

Taking a different approach, Sens. Elizabeth Warren (D-Mass.), Ben Cardin (D-Md.), Sherrod Brown (D-Ohio), and Tammy Baldwin (D-Wis.) Jan. 29 introduced the Medical Innovation Act (S. 320) to boost funding for medical research. The legislation would require large pharmaceutical companies that break the law and settle with the federal government to reinvest a small percentage of their profits into NIH. The senators estimate that if the policy had been in place, over the past five years, NIH would have had nearly $6 billion more every year; an almost a 20 percent increase in NIH funding. Rep. Chris Van Hollen (D-Md.), Jan Schakowsky (D-Ill.), Peter Welch (D-Vt.), and Kathy Castor (D-Fla.) plan to introduce the Medical Innovation Act in the House the week of Feb. 2.

In the House, Reps. Rosa DeLauro (D-Conn.), Brian Higgins (D-N.Y.), and Peter King (R-N.Y.) Jan. 26 introduced the Accelerating Biomedical Research Act (H.R. 531) to allow Congress to restore the purchasing power of the NIH budget to what it would have been if it had kept up with inflation since 2003.

The Accelerating Biomedical Research Act would create a new Budget Control Act cap adjustment for NIH. Any funding provided in excess of $29.4 billion would trigger a budget cap increase to accommodate the additional funding provided to the NIH. The bill would allow appropriations to increase NIH funding by 10 percent for the first two years and about six percent each year thereafter through 2021.

The bill is similar to legislation introduced by DeLauro and Higgins last September [see Washington Highlights, Sept. 19, 2014].

Contact:

Dave Moore
Senior Director, Government Relations
Telephone: 202-828-0559
Email: dbmoore@aamc.org

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Washington Highlights, a weekly electronic newsletter, features brief updates on the latest legislative and regulatory activities affecting medical schools and teaching hospitals.


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Jason Kleinman
Sr. Legislative Analyst, Govt. Relations
Telephone: 202-903-0806
Email: jkleinman@aamc.org