Drugs

Reduced Application Fees Not Sufficient Incentive: Column

FDA’s PDUFA 8 proposal to cut application fees by 50% for qualified drugs to conduct Phase I development in the U.S. is unlikely to achieve that intended result. That’s the opinion of Ovid Therapeutics executive chairman Jeremy Levin.

Writing in a BioSpace opinion post, Levin says that what biotech companies want most from FDA is speed. “Speed matters whether a drug succeeds or fails,” Levin writes. “Finding out earlier that the biology is wrong stops further investment, limits unnecessary exposure of patients, and allows scientists and resources to move elsewhere. Failure is part of science; failing slowly is expensive.”

He reports that in the PDUFA 8 negotiations, industry representatives asked FDA to improve the IND review process alongside the financial incentive. But agency representatives said its “America First” proposal involved only fee adjustments, and other process changes should be considered separately. “But if the goal is to bring more clinical research back to the U.S.,” Levin says, “it makes sense to consider them both together.”

He explains that the “increasingly tense global competition is not simply for Phase 1 trials; it is also for the biotech ecosystem that supports them. Companies decide where to develop medicines based on access to strong investigators and institutions, regulatory engagement, available capital, predictable manufacturing rules, and how quickly one experiment can inform the next. A discounted application fee may help the bottom line, but it does not create conditions supportive of efficient drug development or strengthen biotechnology as a national strategic asset.”

While FDA is beginning to address some of those challenges through Operation TrialBlazer, Levin says, none of the efforts will work without sufficient staff, and FDA needs to repair the damage caused by the staff cuts from the so-called Department of Government Efficiency.

“Without a strong FDA,” Levin concludes, "America risks losing the early scientific development that made it the global biotechnology leader and the agency the world’s regulatory benchmark. PDUFA 8 is not really about fees. It is about whether America intends to remain the country that turns biology into medicines faster, more rigorously, and more reliably than anyone else.”

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

Read more

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