Senate HELP Hearing on FDA User Fees: Advancing Medical Product Regulation and Innovation for Benefits and Patients

On April 26, 2022, the Senate Committee on Health, Education, Labor, and Pensions (HELP) convened a hearing with the directors of the Food and Drug Administration (FDA) to discuss the reauthorization of the FDA user fee amendment programs.

Directors from the FDA Centers discussed how the Prescription Drug User Fee Amendments (PDUFA), the Biosimilar User Fee Amendments (BsUFA), the Generic Drug User Fee Amendments (GDUFA), and the  Medical Device User Fee Amendments (MDUFA) enable the agency to more rapidly review and approve products, as well as support the development of new and innovative products.

The Senators questioned the panel on a variety of FDA-related topics. WHG’ major takeaways from the hearing follow:

COVID-19 – Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research (CBER) detailed that the agency will publicly release a timeline next week for meetings for pediatric COVID-19 vaccine emergency use authorization (EUA).

Clinical Diagnostic Tests – Ranking Member Richard Burr (R-NC) refenced his Verifying Accurate Leading-edge IVCT Development (VALID) Act (S. 2209), and the need to reform the regulatory approach for diagnostic tests Dr. Jeffery Shuren, Director of the Center for Devices and Radiological Health (CDRH) also expressed support for reforming the diagnostic test regulatory approach.

The Accelerated Approval Pathway – Several Senators addressed the approval of Aduhelm through the accelerated approval pathway and Dr. Patrizia Cavazzoni, Director of the Center for Drug Evaluation and Research (CDER) recommended that the program be strengthened through the authority to require confirmatory trials be underway at the time of approval and increased resources to withdraw accelerated approval products from the market.

Orphan Drugs and Rare Diseases – Dr. Marks and Dr. Cavazzoni expressed concern that the recent Catalyst Pharms. v. Becerra ruling would negatively impact rare disease drug development and have a disproportionate impact on the pediatric population.

The Opioid Epidemic –Dr. Cavazzoni detailed that the FDA is considering including mail-back envelopes with opioid prescriptions and the agency is working on expediting approval for over-the-counter naloxone.

Cybersecurity – Sen. Jacky Rosen (D-NV) referenced her new bill the Healthcare Cybersecurity Act and the growing need to ensure cybersecurity for medical devices. Dr. Shuren agreed that medical device cybersecurity is an important topic, not only in the health sector, but for national security.

Erin Slifer joined Wynne Health Group in May 2019, following a year-long internship with the firm’s policy team while pursuing