This Week at FDA: FDA announces new drug voucher program, Prasad gets another role, new CDER director might be named soon

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 launching a pilot program that would significantly shorten certain drug review times, the head of its biologics center will also serve as the top medical and science officer, and a former pharma executive may helm its drug center.

FDA announced that an unspecified number of drug developers will be eligible to participate in a newly announced Commissioner’s National Priority Voucher (CNPV) pilot program. Sponsors participating in the pilot will receive non-transferable vouchers that the agency says will significantly shorten their drug review times.

FDA Commissioner Martin Makary also announced that Vinay Prasad, director of the Center for Biologics Evaluation and Research, will take on a new role as chief medical and scientific officer, in addition to leading the biologics center. In his new capacity, Prasad will be tasked with advising senior agency officials and representing the agency’s thinking on medical and scientific matters to external stakeholders.

STAT News reported that Nicole Verdun, super office director at the Office of Therapeutic Products (OTP) in CBER, and her deputy, Rachael Anatol, were put on administrative leave and escorted out of FDA headquarters this week. Verdun was seen as a close deputy to former CBER Director Peter Marks, who left the agency earlier this year after opposing Robert Kennedy Jr., secretary of the Department of Health and Human Services’ (HHS), policies.

When asked for comment, HHS spokesperson Andrew Nixon told Stat that, “Center directors deserve to be supported by managers that are aligned with aggressive goals to expeditiously advance therapeutics for rare diseases using the gold standard of science.” Several top CBER officials have left their jobs in recent months including Lola Fashoyin-Aje, director of the Office of Clinical Evaluation; Heather Lombardi, director of the Office of Cellular Therapy and Human Tissue CMC; Heather Erdman, associate director of quality assurance in the Office of Review Management and Regulatory Review; and Vaishali Popat, branch chief of General Medicine Branch 3 in the Office of Clinical Evaluation, according to the Pink Sheet.

BioCentury reported that Karim Mikhail, former CEO of Amarin Corporation, has been hired by Makary to serve as a senior adviser and is being considered as the next director of the Center for Drug Evaluation and Research (CDER). Jacqueline Corrigan-Curay has led the drug center as its acting director since Patrizia Cavazzoni left the position in January. Mikhail's LinkedIn page states that he has served as a senior adviser in the Office of the FDA Commissioner since June 2025.

Bloomberg reported that HHS Secretary Kennedy is considering two new policies that could significantly curtail the use of direct-to-consumer (DTC) drug advertisements, which he has long opposed. The policies would either require drugmakers to elaborate on their drug's risk profile, which would make advertisements longer and more expensive, or prevent manufacturers from writing off DTC ads as business expenses in their taxes.

Finally, the US House Energy and Commerce (E&C) subcommittee on health will hold a hearing on 24 June to discuss the HHS FY 2026 budget.

Drugs & Biologics

The FDA Psychopharmacologic Drugs Advisory Committee is scheduled to meet 18 July to discuss Otsuka Pharmaceutical's supplemental new drug application (sNDA) for Rexulti (brexpiprazole) to treat post-traumatic stress disorder (PTSD), in combination with sertraline. The agency has already approved the drug as an antidepressant to treat major depressive disorder (MDD) and schizophrenia.

FDA published a final guidance on conducting post-warning letter meetings under the Generic Drug User Fee Amendments (GDUFA III) agreement. The guidance details how manufacturing facilities can request a post-warning letter meeting to discuss their remediation efforts and address good manufacturing practice (GMP) deficiencies.

FDA announced it is reviewing all new clinical trials that involve using living cells derived from US citizens that would be conducted in countries considered hostile to the US, such as China. The agency said it has "mounting evidence" that some of the trials did not inform participants that their cells would be transported and manipulated and could potentially be misused by adversarial foreign governments.

The Office of Clinical Pharmacology published its annual report. Among its highlights: FDA noted that last year it conducted more than 5,400 investigational new drug (IND) reviews, held 3,300 drug development meetings, and approved 50 novel drugs and biologics.

Incyte Corp.'s drug Monjuvi (tafasitamab-cxix) was approved to treat patients with relapsed or refractory follicular lymphoma (FL) in combination with lenalidomide and rituximab. FDA notes the drug was reviewed under Project Orbis so that it could be concurrently submitted and reviewed by the Australian Therapeutic Goods Administration (TGA) and Health Canada.

Medtech Products issued a recall of its Little Remedies honey cough syrup after Bacillus cereus bacteria were found in the products, which could cause foodborne illnesses. The FDA noted that the lots of cough syrup in question were distributed between December 2022 and June 2025.

Medtech

Clinical electronic thermometers are now exempt from requiring 510(k) premarket notification as long as they are not clinical thermometers with telethermographic functions or continuous temperature measurement functions and meet specific standards. FDA first announced its intention to exempt the devices from class II requirements in 2023.

Zyno Medical initiated a Class I recall for certain Z-800 Series infusion pumps after it discovered that they were distributed with software that had not been verified and validated. According to the FDA, the pumps in question can have performance problems and issues with risk measures such as air-in-line detection, alarm volume, and reverse flow prevention.

Medline Industries announced a class I recall for its neonatal and pediatric convenience kits containing recalled Smiths Medical ORAL/NASAL Endotracheal Tubes due to concerns that they may have smaller than expected diameters, preventing proper ventilation. FDA notes that Medline has reported eight injuries due to the issue, but no deaths.

Fresenius Kabi issued a Class I recall for a specific lot of its Ivenix LVP Blood Products Administration Set that it says was incorrectly assembled. The company reported that the primary and secondary inlet lines were reversed in the affected products, which could cause patients to receive unfiltered blood.

Q’Apel Medical issued a Class I recall for its Hippo 072 Aspiration Systems after FDA sent the company a warning letter. The letter raised concerns about the distal tip used to remove clots during aspiration. If the tip doesn't function as intended, it could lead to serious injuries and death.

This Week at FDA: FDA announces new drug voucher program, Prasad gets another role, new CDER director might be named soon

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