NE Washington News

Washington D.C. — House Energy and Commerce Subcommittee on Health Chair Brett Guthrie (R-KY) delivered opening remarks at a subcommittee hearing titled “Check Up: Examining FDA Regulation of Drugs, Biologics, and Devices.”

“Today, three important center directors at the U.S. Food and Drug Administration are here with us to share updates about the work they oversee within their respective divisions,” said Guthrie.

Guthrie emphasized the significance of user fees collected by the agency and highlighted the need to understand challenges in getting safe and effective products to patients more quickly. He noted that Congress had granted the FDA additional authorities in December 2022, including updates for clinical trials, greater transparency for sponsors, reforms to strengthen the accelerated approval pathway, and streamlined processes for manufacturers.

“I am proud of the bipartisan work this subcommittee has accomplished throughout the last user fee reauthorization. Since then, the FDA has approved and cleared hundreds of new products,” he stated.

Guthrie cited specific accomplishments: 55 novel drugs approved in 2023, nearly 1,000 generic drug applications approved, 23 biologics device applications approved, 20 biologics license applications approved, and over 100 novel devices cleared by the FDA.

He expressed particular interest in cell and gene therapy. “We’re at the precipice of a renaissance in health care... For example, among those medicines approved in 2023 were two cutting-edge, potentially curative gene therapies for sickle-cell disease,” he mentioned.

However, Guthrie raised concerns about actions by the Biden administration affecting innovation pathways. “Missteps by the Biden administration have already caused uncertainty amongst innovators... The repeated attacks on the Accelerated Approval pathway... degrade public trust in an important tool.”

He also addressed concerns regarding a new Laboratory Developed Test (LDT) rule proposed by CDRH. “I fear this complete overhaul of LDT regulation will have the opposite effect—instead driving up costs of care and delaying patient access to life-saving care.”

Guthrie discussed bipartisan concerns about clinical holds on research. He referenced a letter sent to Dr. Marks addressing an increase in clinical holds from an average of 557 annually before 2017 to an average of 664 between 2017 and 2021.

“It is imperative for the agency to come to the table and work through these issues with innovators or else patients will be left without answers and without life-saving care,” he asserted.

In closing his remarks, Guthrie thanked witnesses for their presence and stressed collaboration to bring innovative technologies to market efficiently.

“I know your work is not easy... It’s important accelerated pathways are real and important... we want to work together,” he concluded.

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