This Week at FDA: Prasad’s exit from CBER, 7-OH scheduling, updated opioid labeling

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, the head of the FDA’s biologics center resigned under pressure after a brief tenure at the agency, FDA has recommended classifying certain kratom-derived products as controlled substances, and the agency is requiring several changes to opioid labeling to further stress their risks.

After only three months on the job, Vinay Prasad was forced to resign from him role as director of FDA’s Center for Biologics Evaluation and Research earlier this week. Prasad came under fire from several right-wing figures who accused him of working to sabotage the Trump administration’s plans for the agency. Prasad was also embroiled in the agency’s recent actions involving Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec-rokl).

On 20 July, Laura Loomer, an influential far-right media personality published an article calling Prasad a “progressive leftist saboteur” and citing his past tweets praising progressive senators Elizabeth Warren (D-MA) and Bernie Sanders (I-VT) and expressing support for former President Joe Biden in the 2020 election.

A week later, The Wall Street Journal published an editorial by Allysia Finley that alleged Prasad doesn’t trust patients “to make their own healthcare decisions” based on his past writings critical of FDA for approving drugs with minimal benefits. While she noted that Prasad was aligned with FDA Commissioner Marty Makary on the administration's COVID-19 vaccine policies, he stands at odds with the administration on issues such as more flexible drug reviews and its work on patient empowerment.

Finley also took aim at Prasad for FDA's recent back and forth with Sarepta. She noted that Prasad has hyped the side effects of certain cancer therapies while stating they are too expensive with little benefit. She said that he used the recent news of two patients dying in late-stage trials for Elevidys to "deep-six the drug," which should have been allowed to move forward and left to physicians and patients to decide.

After a brief pause, Sarepta announced this week that FDA has allowed it to continue shipping Elevidys for use in ambulatory patients.

The day after Prasad resigned, Makary appeared on CNBC’s Squawk Box, calling Prasad a genius, and said the attacks in the WSJ were unfair and that Prasad ultimately left FDA because the commute from his family in California was “brutal.” Politico, however, reported that President Trump overruled Makary and Health and Human Services Secretary Robert F. Kennedy Jr. and ordered Prasad out. Politico also noted that George Tidmarsh, director of the Center for Drug Evaluation and Research (CDER), who was only appointed last week, will take over as acting CBER director, and that the Trump administration is considering splitting CBER into two new centers focused on vaccines and therapeutics.

Leading House Democrats wrote to Makary about the agency's recent decisions to change its vaccine approval policies. Reps. Frank Pallone (D-NJ), Diana DeGette (D-CO), and Yvette Clarke (D-NY) said they are especially troubled by the agency's actions that will likely interfere the ability of Americans to receive their COVID-19 vaccines.

Caleb Michaud, FDA's former director of Organizational Communication and Engagement in its Office of Inspections and Investigations (OII), has been announced as the new acting associate commissioner for external affairs.

Makary has eliminated FDA's Arthritis Advisory Committee because he said it is no longer necessary. FDA said the committee has met infrequently and it can no longer justify the effort and expense to maintain it.

FDA's Office of Orphan Products Development (OOPD) announced a study grant through its Orphan Products Natural History Studies Grants Program to "address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development." Stakeholders can apply for the first round of grants starting 12 December, and letters of intent are due by 9 January 2026.

FDA has added another meeting between Makary and pharmaceutical and biotech CEOs as part of his listening tour. The commissioner is scheduled to meet with industry executives in Raleigh, NC, tentatively on 15 September.

Drugs & Biologics

Kennedy and Makary recommended that certain 7-hydroxymitragynine (7-OH) products be scheduled as controlled substances under the Controlled Substances Act (CSA). HHS and FDA noted the concentrated byproduct from kratom plants has the potential for abuse and are especially concerned that they may be being marketed to children in fruit-flavored gummies and ice cream cones.
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FDA announced it is requiring labeling changes to all approved opioid drugs to emphasize and explain the risks they pose to long-term use. The labeling will now include data from two postmarket studies on the long-term risks from using opioids.

FDA announced that its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program has been made into a permanent drug development tool (DDT) qualification program. The pilot began in November 2020, and the agency says its success has led it to permanently make it a DDT, which means it will continue to focus on tools that don’t fall within the agency’s existing qualification pathways.

Medtech

FDA reminded stakeholders that its first public meeting to reauthorize the Medical Device User Fee Amendments (MDUFA VIII) is set to kick off on Monday, 4 August. In-person registration for the meeting has closed, but interested parties can still sign up to participate via Microsoft Teams.

FDA announced it has recognized the International Electrotechnical Commission's (IEC) standard for in vitro diagnostics (IVD) used for electrical equipment for measurement, control and laboratory use: IEC 61326. The agency notes the recognized consensus standard is intended for evaluating IVD basic safety and essential performance.

This Week at FDA: Prasad’s exit from CBER, 7-OH scheduling, updated opioid labeling

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