Drugs

Representative Questions Voucher Program Legality

Rep. Jake Auchincloss (D-MA) says the FDA Commissioner’s National Priority Voucher (CNPV) program may not be legal since it was created by the agency itself and not by Congress. The Associated Press reports that Auchincloss wrote to FDA asking that it affirm or refute his concerns about the program’s legality and the ways in which it is operating.

AP reports the agency had scheduled a 2/3 employee town hall on CNPV, which gives selected drug manufacturers vouchers for expedited review (advertised to be one-to-two months) for drugs that support “national interests” defined by FDA. It says CNPV has become a “flashpoint for controversy outside and inside the agency with several senior staffers declining to sign off on drug approvals going through the program.”

“The public must have transparency about the voucher program,” Auchincloss is quoted as saying, “under which drug approvals have been made almost wholly and in an unprecedented manner by FDA’s political leadership.” He said the agency has failed to publish or disclose financial disclosure forms for eight senior FDA officials who vote on which drugs should receive CNPV vouchers. He said the executives include deputy commissioner Sara Brenner, CBER director Vinay Prasad, and CDER director Tracy Beth Høeg.

In his letter, Auchincloss said FDA had not responded to his previous two letters seeking information on CNPV. AP notes that in 11/2025, Sen. Bernie Sanders (I-VT) and Rep. Frank Pallone (D-NJ) wrote to FDA posing 15 questions about the voucher program. The agency never replied, it says.

HHS did not respond to an AP request for comment on Auchincloss’ letter, the article says.

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