This Week in Washington: House Passes FDA User Fee Reauthorization Package




House to Consider the ARPA-H Act

On June 20, the House will consider H.R. 5585, the Advanced Research Projects Agency-Health (ARPA-H) Act. The bill would establish ARPA-H, a new biomedical research agency, within the Department of Health and Human Services (HHS). The bill would also require ARPA-H to coordinate with the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) on product and coverage decisions, and would allocate $5 million to fund the agency. The ARPA-H Act would override HHS’s recent decision to place ARPA-H in the National Institutes of Health (NIH).

House Passes FDA User Fee Reauthorization Package

On June 8, the House voted 392-28 to pass the Food and Drug Amendments of 2022, which would reauthorize the Food and Drug Administration (FDA) prescription drug, generic drug, biosimilar and medical device user fee programs. The legislation would require sponsors to begin post-approval studies before drugs go on the market and for manufacturers to develop a clinical trial diversity action plan. In addition, the legislation would extend additional hiring flexibility to the FDA.

Reps. Hoyer and Clyburn Call in Op-Ed for Preserving American Rescue Plan Premium Tax Credits

On June 7, House Majority Leader Steny Hoyer (D-MD-05) and Majority Whip James Clyburn (D-SC-06) wrote an op-ed in The Hill titled “Congress must not forget about protecting access to affordable health coverage.” In the article, Reps. Hoyer and Clyburn stressed the importance of preserving the American Rescue Plan premium tax credits.

Rep. Jacobs Introduces Bill to Protect Reproductive Health Data

On June 2, Rep. Sara Jacobs (D-CA-35) introduced the My Body, My Data Act. The bill would create a national standard to protect personal reproductive health data, enforced by the Federal Trade Commission. The bill would prevent reproductive health data that is collected from being disclosed or misused. This bill is introduced amid concerns that reproductive health data could be used to target people if the Supreme Court overturns Roe v. Wade.


Senate HELP Committee to Discuss Four Bills

On June 14, the Senate Health, Education, Labor and Pensions (HELP) Committee will hold an executive session to discuss four bills. The bills can be found below.

  • 4353, Retirement Improvement and Savings Enhancement to Supplement Healthy Investments for the Nest Egg (RISE and SHINE) Act
  • R. 1193, Cardiovascular Advances in Research and Opportunities Legacy Act
  • 4052, Early Hearing Detection and Intervention Act of 2022
  • 4348, Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act
  • 958, Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act

Sen. Barrasso Leads 25 Senators in a Letter to HHS Calling for Clarification on PHE Unwinding

On June 10, Sen. John Barrasso (R-WY) and 24 other senators sent a letter to Secretary of Health and Human Services (HHS) Xavier Becerra calling for HHS to clarify its plans for transitioning out of the COVID-19 public health emergency (PHE).

Sen. Wyden and Rep. Pallone Call on CMS To Ensure Provider Choice for Medicaid Beneficiaries

On June 8, Sen. Ron Wyden (D-OR) and Rep. Frank Pallone (D-NJ) wrote to the Administrator of the Centers for Medicare and Medicaid Services (CMS) Chiquita Brooks-LaSure expressing their concern about state efforts to exclude Planned Parenthood and other family planning providers from Medicaid. Sen. Wyden and Rep. Pallone note that this violates federal law, and called on CMS to take measures to ensure that Medicaid beneficiaries can access services from the providers they choose.

Sens. Leahy and Cornyn Call on Patent and Trade Office to Address Patent Thickets

On June 8, Sens. Patrick Leahy (D-VT) and John Cornyn (R-TX) led six senators in a letter to the U.S. Patent and Trademark Office (USPTO). In the letter, the senators call for the USPTO to address patent thickets, which is defined as a large number of patents that cover a single product, extending patent protections for longer. The senators raised concerns that patent thickets were negatively impacting competition in the pharmaceutical sector.

18 Members of Congress Write to FDA Expressing Concern with Method of Authorizing COVID-19 Vaccines for Children

On June 7, Sens. Ron Johnson (R-WI) and Ted Cruz (R-TX), along with Rep. Bill Posey (R-FL) and Rep. Louie Gohmert (R-TX), led a group of 18 members of Congress in a letter to the Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC). In the letter, the members raise concerns about the Centers for Disease Control and Prevention (CDC) and the FDA’s approach to emergency use authorizations of COVID-19 vaccines for children under five.

Sens. Rosen and Young Introduce Bill to Improve Medical Device Cybersecurity

On June 3, Sens. Jacky Rosen (D-NV) and Todd Young (R-IN) introduced the Strengthening Cybersecurity for Medical Devices Act. The bill would require the Food and Drug Administration (FDA) to update medical device cybersecurity guidelines to better protect devices from possible cyberattacks.

Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.