This week at FDA: Biosimilar updates, FDA staff changes, and more

Welcome to another installment of This Week at FDA, your weekly source for updates—big and small—on FDA, drug, and medical device regulation and what we’re reading from around the web. This week, FDA announced it is revamping and simplifying its policies for biosimilars, there are reports of a staff shakeup at the agency’s Office of the Chief Medical Officer, and news of a potential end to the ongoing government shutdown.

Senate Republicans and Democrats are currently negotiating a plan to end the government shutdown, which could be resolved as early as next week, according to a report in The Hill. The report mentions that “shutdown fatigue on Capitol Hill is growing as the government stoppage approaches the one-month mark, and the pain is increasing.”

In remarks at the AAM GRx+Biosims meeting in Rockville, MD earlier this week and at a Department of Health and Human Services press conference, FDA Commissioner Marty Makary said that the agency will be overhauling its policies for approving biosimilars. The agency issued a draft guidance outlining when comparative efficacy studies are necessary, which Makary said would be finalized in three to six months. Makary also said the agency would issue final guidance on demonstrating biosimilar interchangeability. Speaking at the GRx+Biosims meeting, Makary said that “every biosimilar should have the designation of interchangeable. We need more biosimilars on the market. We need to recognize that biosimilars have the promise of lowering drug prices, a major priority in this administration.

During the meeting, Makary shared some of the unexpected challenges he has faced since becoming the commissioner. One of the biggest surprises for him has been the transition from being a surgeon at Johns Hopkins to serving as a political appointee leading FDA.

Makary said that “it is very different for me. I am looking at this awesome big audience, and just seven months ago before my confirmation hearing, I was still in the operating room and here I am. It is a big transition for me.”

He added that “As a surgeon at Hopkins everyone wanted me to succeed, and I took that for granted … people are cheering for you … then you walk into this politically appointed position, and the minute you take your job, 30% of the country hate your guts.”

“If we can turn off the echo chamber of social media and the media news that we get pulled into and the toxic polarization that is really crippling our society, and by focusing on health, we have an incredible opportunity to unite,” Makary added.

This week, STAT News reported on the increasing tension between Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad and his staff. According to STAT’s reporting, a "slow-boiling feud" between Prasad and his team at FDA is jeopardizing the future of CBER, which regulates the nation’s vaccines, biological products, and blood supply. Furthermore, dozens of scientists are reportedly considering leaving CBER to escape a work environment described to STAT by eight agency officials as "rife with mistrust and paranoia."

AgencyIQ reported that Prasad, who also serves as the agency’s chief medical and scientific officer has purged much of the leadership from the Office of the Chief Medical Officer, including Dionna Green, who led the Office of Pediatric Therapeutics, Ann Meeker-O’Connell, who directed the Office of Clinical Policy, Sandy Retzky, who headed the Office of Orphan Products Development, and Daniel Singer, who directed the Office of Public Health Preparedness and Response.

Additionally, Mary Thanh Hai has been made the permanent director of the Office of New Drugs within the Center for Drug Evaluation and Research after serving as acting director since Peter Stein was fired earlier this year, according to her LinkedIn profile.

Drugs & biologics

FDA's Office of Generic Drugs has released its quarterly activities report on generic drug approvals, revealing a decrease in the agency's approval of original Abbreviated New Drug Applications (ANDAs) for fiscal year 2025. The agency approved 689 generic drugs in FY 2025, a decline from 694 approvals in FY 2024 and 782 approvals in FY 2023.

A draft guidance on the use of Bayesian methodology in clinical trials for drugs and biologics reached the White House Office of Management and Budget for review earlier this week and could be released soon.

The agency has announced its intention to restrict and remove unapproved ingestible fluoride prescription drugs intended for children due to safety concerns. The agency has sent notices to four companies, indicating plans to take enforcement action against those marketing unapproved fluoride-containing ingestible drugs labeled for use in children under age 3, as well as for older children who are at low to moderate risk for tooth decay.

FDA has reported that drug manufacturers have recalled over half a million bottles of the blood pressure medication prazosin hydrochloride due to concerns that it may contain a cancer-causing chemical, said the Associated Press. Teva Pharmaceuticals USA and distributor Amerisource Health Services have issued voluntary nationwide recalls earlier this month for more than 580,000 bottles of various strengths of prazosin capsules. Besides being used to treat high blood pressure, the drug is also used to treat nightmares and other sleep disturbances related to post-traumatic stress disorder (PTSD).

A federal judge in Hawaii ruled that FDA violated the law by restricting access to the abortion medication mifepristone, according to the Associated Press. The lawsuit was filed by the American Civil Liberties Union, which argued that FDA continues to impose excessive restrictions on mifepristone without scientific justification.

The agency also announced that is has cancelled its 17^th Annual Sentinel initiative public workshop, which was scheduled for 6 November.

The American Academy of Pediatrics (AAP) on Friday announced that it does not recommend leucovorin (folinic acid) for routine use to treat children with autism, following FDA’s approval of the drug last month. “The current evidence base remains too limited to support specific clinical recommendations. Key questions about who may benefit, what dosing and monitoring are appropriate, and what the long-term safety profile looks like have not yet been adequately answered,” AAP wrote, calling for larger, well-controlled trials of the drug.

Drugmaker Eli Lilly believes its investigational weight-loss pill orforglipron meets most of the criteria for FDA’s recently announced Commissioner’s National Priority Voucher pilot program and that it plans to submit the drug for review later this year, Reuters reports. Earlier this month, FDA awarded the first nine vouchers under the program, which offer a 1-2 month priority review for the selected products.

Devices

FDA has published a draft guidance about its expectations related to the Quality Management System Regulation (QMSR) requirements and Quality Management System (QMS) information included in premarket approval applications (PMAs) and Humanitarian Device Exemption (HDE) applications. The guidance is intended to assist medical device manufacturers in preparing and maintaining a QMS and providing the necessary information that should be included in marketing submissions regarding a QMS stemming from the QMSR.

The agency also released draft guidance on performance testing and labeling of menstrual products subject to a 510(k) notification. This guidance pertains to tampons, pads, and menstrual cups used for collecting menstrual fluid.

FDA has issued warning letter to Philips Ultrsound and Philips Medical Systems Nederland B.V. for three facilities—one located in the Netherlands and two in the United States— concerning the company’s ultrasound equipment and imaging software. The company was cited for not establishing and maintaining adequate procedures to ensure that all purchased or received products and services meet specified requirements, as mandated by 21 CFR 820.50. Additionally, Philips failed to establish and maintain procedures for evaluating feedback.

The agency's Digital Health Advisory Committee has announced that it will meet virtually on 6 November to discuss digital mental health medical devices that utilize generative AI. During this meeting, the Committee will examine the benefits and risks associated with these devices, as well as potential risk mitigation strategies.

This week at FDA: Biosimilar updates, FDA staff changes, and more

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