Drugs

FDA, Industry Debate ‘America First’ User Fee Incentive

FDA and drug-industry negotiators exchanged early feedback on the agency’s proposed “America First” fee incentives for domestic drug development during an 11/13 Prescription Drug User Fee Act (PDUFA) reauthorization steering committee meeting, according to newly released minutes. The proposal, first outlined by FDA at an 11/6 meeting, aims to steer more early-stage development back to the U.S. by adjusting PDUFA fees. Industry representatives from BIO, PhRMA, and CHPA said they support the goal of improving U.S. competitiveness but questioned whether PDUFA fee policy is the appropriate lever.

Executives acknowledged that more companies are initiating development outside the U.S. due to time, cost, and complexity. Still, they warned that fee-based incentives could create unintended burdens, particularly for small and emerging biotechs, and would be difficult for FDA to administer. They argued that because roughly 90% of drugs never reach a marketing application — and therefore never reach the PDUFA fee stage — fee incentives are unlikely to change companies’ early-development decisions.

Instead, industry urged FDA to focus on underlying contributors to foreign development migration, including lengthy early-phase review times, clinical-trial administrative demands, and requirements that vary across programs. Suggestions included shortening Phase 1 review timelines, standardizing documents and processes, expanding reliance on single IRBs, clarifying toxicology and new approach methodology expectations, and applying quality-risk-management principles more consistently in CMC reviews. FDA agreed to revisit its fee-incentive proposal later in the negotiations.

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