This Week in Washington: FDA Approves Narcan OTC Nasal Spray, Senate Finance Committee Investigates Pharmacy Benefit Manager Practices


House and Senate on Recess


VALID Act Re-introduced

On March 29, Reps. DeGette (D-CO) and Bucshon (R-IN) reintroduced the Verifying Accurate, Leading-edge IVCT Development (VALID) Act. The bill would give the Food and Drug Administration (FDA) explicit authority to regulate certain laboratory-developed tests (LDT). The FDA has sought to regulate LDTs that are currently overseen by the Centers for Medicare and Medicaid Services (CMS).

In the last days of the Obama administration, the FDA published a guidance to use a risk-based approach to oversee LDTs. The guidance was rejected by the Trump administration. The then-FDA Commissioner Scott Gottlieb said he believed that Congress needed to legislate. Current FDA Commissioner Robert Califf has said he would consider rule-making but has also said he would prefer Congress provide explicit authority to regulate these tests.

For more information, click here.

House Energy and Commerce Committee Chair Presses FDA on Gain-of-Function Research

On March 27, House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Reps. Guthrie (R-KY) and Griffith (R-VA) sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf requesting that the FDA provide specifics regarding any gain-of-function experiments conducted during coronavirus research experiments. The Energy and Commerce Committee is investigating whether the FDA is adequately monitoring and overseeing FDA-funded research that has the potential of creating biosafety and biosecurity risks.

For more information, click here.


Reentry Act Introduced

On March 30, Sens. Baldwin (D-WI) and Braun (R-IN) introduced the Reentry Act. The bipartisan legislation would expand access to healthcare and mental health services for Medicaid-eligible individuals who are within 30 days of being released from prison or jail. The bill would also make it easier for states to provide substance-use disorder treatment services and provide previously incarcerated individuals a smoother transition back into their communities.

For more information, click here.

Senate Finance Committee Examines PBMs

On March 30, the Senate Finance Committee held a hearing on pharmacy benefit managers (PBMs). The committee is interested in learning more about what impacts PBM tactics are having on the prescription drug supply chain, particularly on prescription drug pricing. Witnesses included:

  • Robin Feldman, Arthur J. Goldberg Distinguished Professor of Law and Director of the Center For Innovation at the University of California Hastings College of Law
  • Karen Van Nuys, Ph.D., Executive Director of the Value of Life Sciences Innovation Leonard D. Schaeffer Center at the University of Southern California Center for Health Policy and Economics
  • Lawton Robert Burns, Ph.D., James Joo-Jin Kim Professor of Health Care Management and Co-Director of the Roy and Diana Vagelos Program in Life Sciences and Management at the University of Pennsylvania Wharton School
  • Matthew Gibbs, Pharm.D., President of Capital Rx
  • Jonathan E. Levitt, Founding Partner of Frier Levitt Attorneys at Law

For more information, click here.

Senate Finance Committee Holds Hearing on Oral Health Disparities

On March 29, the Senate Finance Committee held a hearing on identifying and addressing oral health disparities. Witnesses included:

  • Warren A. Brill, DMD, MS (HYG), FAAPD, FACD, FICD, Owner of Eastpoint Pediatric Dental Associates
  • Jonathan P. Forte, MHA, FACHE, President and CEO of RiverStone Health
  • Cherae M. Farmer-Dixon, DDS, MSPH, FACD, FICD, Dean and Professor of Meharry Medical College, School of Dentistry
  • Marko Vujicic, Ph.D., Chief Economist and Vice President of the American Dental Association Health Policy Institute

For more information, click here.

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