Legislative Activity

While passing health reform through Congress has been a struggle, the Food and Drug Administration (FDA) user fee legislation has quickly moved through the regular order process in a bipartisan fashion. S. 934/H.R. 2430, Food and Drug Administration Reauthorization Act of 2017 (FDARA), renews FDA’s authority to collect user fees from the makers of prescription brand drugs, medical devices, generic drugs, and biosimilars. The user fees account for over a quarter of all funding for the FDA, and are essential for the FDA to implement H.R. 34, 21st Century Cures Act. The 2012 Prescription Drug User Fee Amendments (PDUFA), Medical Device User Fee Amendments (MDUFA), Generic Drug User Fee Amendments (GDUFA), and Biosimilar User Fee Act (BsUFA) all must be reauthorized by Congress before September 30. The Senate Health, Education, Labor, and Pensions (HELP) Committee passed S. 934, introduced by Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA), as amended, on May 11 by a vote of 21 ayes to 2 nays. The House Committee on Energy and Commerce Subcommittee on Health passed H.R. 2430, introduced by Chairman Greg Walden (R-OR), Ranking Member Frank Pallone (D-NJ), Subcommittee Chairman Michael Burgess (R-TX), and Subcommittee Ranking Member Gene Green (D-TX), as amended, on May 18 by a voice vote. The Subcommittee vote occurred days after Department of Health and Human Services (HHS) Secretary Tom Price urged Congress to double the industry fees to pay for the full cost of FDA’s evaluation of their products. The request has been largely ignored, but received pushback from Ranking Member Pallone in Thursday’s markup. Although it has yet to be officially announced, H.R. 2430 is expected to be examined by the Full Committee this week. Committee leadership in the House and Senate are encouraged by the progress made. They hope to have an agreed upon package pass the House and Senate in June, and be signed by the President in July.

This Week’s Hearings:

  • On Tuesday, May 23, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations will hold a hearing titled “U.S. Public Health Response to the Zika Virus: Continuing Challenges.” The witnesses will be:
    • Dr. Luciana Borio, Acting Chief Scientist, Food and Drug Administration;
    • Dr. Rick A. Bright, Director, Biomedical Advanced Research and Development Authority, Deputy Assistant Secretary, Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services;
    • Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health;
    • Dr. Timothy Person, Chief Scientist, Government Accountability Office; and
    • Dr. Lyle R. Petersen, Director, Division of Vector-Borne Diseases, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention
  • On Wednesday, May 24, the House Committee on Appropriations Subcommittee on Interior, Environment, and Related Agencies will hold a hearing titled “Budget- Indian Health Service.” The witness will be:
    • Rear Admiral Chris Buchanan, Acting Director, Indian Health Service
  • On Wednesday, May 24, the House Committee on Appropriations Subcommittee on Interior, Environment, and Related Agencies will hold a hearing titled “Oversight- High Risk American Indian and Alaska Native Programs (Education, Health Care, and Energy).” The witnesses will be:
    • Ms. Melissa Emrey-Arras, Director, Education, Workforce and Income Security Team, Government Accountability Office;
    • Ms. Kathleen King, Director, Health Care Team, Government Accountability Office; and
    • Mr. Frank Rusco, Director, Natural Resources and Environment Team, Government Accountability Office
  • On Wednesday, May 24, the House Committee on Veterans’ Affairs will hold a hearing titled “U.S. Department of Veterans Affairs Budget Request for Fiscal Year 2018.” The witness will be:
    • The Honorable David J. Shulkin, Secretary, Department of Veterans’ Affairs
  • On Thursday, May 25, the House Committee on Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies will hold a hearing titled “Budget- Food and Drug Administration.” The witness will be:
    • Dr. Scott Gottlieb, Commissioner, Food and Drug Administration

Regulatory Activity

HHS Further Delays Bundled Payment Models and Changes to 340B Drug Discount Program

On Thursday, May 18, HHS issued a notice to delay the starting date of payment models for knee and hip replacements and cardiac care until January 1, 2018. The bundled payments were previously delayed due to the Administration’s freeze on pending rules and regulations. The added delay gives providers more time to prepare for the enforcement of the payment models, and allows the agency to make any final changes. In a separate final rule, the Health Resources and Services Administration (HRSA) further delayed changes to the 340B Drug Discount Program. The agency previously delayed the implementation of the 340B ceiling price and civil monetary penalty rule which was scheduled to take effect on May 22, 2017. These policies will now begin on October 1, 2017.