Drugs

Expedite FDA Review of Breakthrough Mental Health Therapies: House Letter

Some 30 bipartisan members of the House of Representatives are calling on FDA to advance its evaluation of rapid-acting novel therapeutics, including entactogen and psychedelic-assisted therapies, to treat serious mental health conditions. In a letter organized by Reps. Jack Bergman (R-MI) and Lou Correa (D-CA) the lawmakers say that for many Americans struggling with complex mental health challenges, existing treatment options fall short.

“This gap in care is felt acutely among veterans, who experience rates of PTSD, depression, and suicide far exceeding those of the general population, and it has contributed to a growing and urgent public health crisis affecting individuals, families, and communities across the country,” the letter says.

The representatives ask FDA for information on:

how the agency communicates and applies any remaining data concerns beyond clearly defined primary endpoints and control conditions when pivotal trials are conducted under a special protocol assessment;
the steps FDA is taking to clarify methodological expectations for entactogen and psychedelic-assisted clinical trials;
how FDA ensures that qualified experts with relevant experience conduct reviews of entactogen and psychedelic-assisted therapies; and
the expected timeline for finalizing the agency’s 6/2023 guidance on clinical trials involving rapid-acting novel therapeutics.

The letter urges FDA to provide further clarity in the final guidance around:

strategies to mitigate functional unblinding and expectancy bias;
standards for adverse event monitoring and safety reporting;
the evolving role of psychotherapy in conjunction with drug interventions;
generalizability of findings across diverse patient populations; and
consistency in regulatory expectations across entactogen and psychedelic drug development programs.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome