POLICY BRIEFINGS

Agreement Reached on PDUFA VII Commitment Letter


The Food and Drug Administration has reached an agreement with the pharmaceutical industry on the next round of prescription drug user fees. The parties released the commitment letter last Monday outlining the goals and procedures for the seventh reauthorization of the Prescription Drug User Fee Act (PDUFA VII) spanning 2023 through 2027. The agreement letter directs the agency, including the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), to improve staff hiring and retention, upgrade information technology, and to further incorporate real-world evidence (RWE) into regulatory decision making. Congress must pass legislation to renew the user fees, which fund 70% of CDER’s annual budget, before the current authorization expires in September 2022.


Upcoming Congressional Hearings and Markups


House Small Business Committee hearing “What Comes Next? PPP Forgiveness;” 1:00 p.m.; September 1

House Homeland Security Subcommittee on Cybersecurity, Infrastructure Protection, & Innovation hearing “Stakeholder Perspectives on the Cyber Incident Reporting for Critical Infrastructure Act of 2021;” 12:00 p.m.; September 1


Recently Introduced Health Legislation


H.R.5067 — To amend title XVIII of the Social Security Act to clarify congressional intent and preserve patient access to home infusion therapy under the Medicare program, and for other purposes. Sponsor: Rep. Sewell, Terri A. [D-AL-7]; Committees: House - Energy and Commerce; Ways and Means

H.R.5061 — To direct the Secretary of Defense to carry out a pilot program to survey access to mental health care under the military health system, and for other purposes. Sponsor: Resident Commissioner Gonzalez-Colon, Jenniffer [R-PR-At Large]; Committees: House - Armed Services

H.R.5054 — To amend title XVIII of the Social Security Act to improve the accuracy of geographic adjustment factors under the Medicare program and to permanently extend certain adjustments to such factors for certain localities, and for other purposes. Sponsor: Rep. Axne, Cynthia [D-IA-3]; Committees: House - Energy and Commerce; Ways and Means

H.R.5073 — To improve the Veterans Crisis Line of the Department of Veterans Affairs, and for other purposes; Sponsor: Rep. Delgado, Antonio [D-NY-19]; Committees: House - Veterans’ Affairs

H.Res.603 — Expressing support for the designation of the week of August 25 through August 31, 2021, as “Black Breastfeeding Week” to bring national attention to the United States maternal child health crisis in the Black community and the important role that breastfeeding plays in improving maternal and infant health outcomes; Sponsor: Rep. Adams, Alma S. [D-NC-12]; Committees: House - Energy and Commerce

H.R.5086 — To amend the Comprehensive Addiction and Recovery Act of 2016 to authorize the Attorney General, in coordination with the Administrator of the Drug Enforcement Administration, the Secretary of Health and Human Services, and the Director of the Office of National Drug Control Policy, to award grants to covered entities to establish or maintain disposal sites for unwanted prescription medications, and for other purposes; Sponsor: Rep. Bonamici, Suzanne [D-OR-1]; Committees: House - Energy and Commerce

H.R.5091 — To establish certain requirements with respect to the appointment of the Attending Physician, and for other purposes; Sponsor: Rep. Gohmert, Louie [R-TX-1]; Committees: House - House Administration

H.R.5092 — To prohibit the federal government from requiring any citizen to be vaccinated, including federal agencies from requiring its employees to take any vaccination, without the citizen being fully advised in writing of all known potential risks from the vaccine and consultation with a physician followed by the voluntary informed consent of the citizen, and for other purposes; Sponsor: Rep. Gohmert, Louie [R-TX-1]; Committees: House - Energy and Commerce; Judiciary; Oversight and Reform

H.R.5094 — To amend title XX of the Social Security Act to provide for nursing home worker training grants; Sponsor: Rep. Horsford, Steven [D-NV-4]; Committees: House - Ways and Means

H.R.5099 — To amend title XVIII of the Social Security Act to move Medicare cost-sharing benefits from Medicaid to Medicare, and for other purposes; Sponsor: Rep. Schneider, Bradley Scott [D-IL-10]; Committees: House - Energy and Commerce; Ways and Means



August 30, 2021: | Page 1 Page 2

SERVICES



BRIEFING ARCHIVE

 -  2023

 +  2022

 +  2021

 +  2020

 +  2019

 +  2018