This Week at FDA: Høeg expected to depart FDA following Makary’s resignation

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. In major news this week, FDA is facing two high-profile departures, beginning with the resignation of FDA Commissioner Marty Makary, who stepped down on Tuesday after just one year in office.

On Friday, news emerged that Tracy Beth Høeg, the acting director of the Center for Drug Evaluation and Research (CDER), is expected to leave the agency, according to Reuters. However, this information has not yet been confirmed by the Department of Health and Human Services (HHS) or FDA.

Høeg’s departure comes amid reports of tension over a commissioner’s voucher for Sanofi’s diabetes drug, said Reuters. Høeg served as interim chief of the drug center for approximately five months and was the fifth person to hold this position since President Donald Trump began his second term. The details regarding her departure remain unclear, as a spokesperson for HHS declined to comment on personnel matters to Reuters. As a Makary ally, Høeg represented the agency on the Centers for Disease Control and Prevention’s (CDC’s) vaccine advisory committee and was involved in efforts to pare down the childhood vaccine schedule.

Makary's tenure was marked by conflicts with the administration over issues such as vaping and abortion, as well as backlash regarding his stance on other healthcare products like vaccines. The latest controversy was Makary’s reluctance to approve flavored vapes and other nicotine products. Kyle Diamantas, who currently serves as FDA deputy commissioner for food, will step up as acting FDA commissioner.

Among the challenges faced by Makary was criticism from public health leaders who believed he was catering to anti-vaccine activists. This backlash came after he released a memo claiming that deaths were linked to COVID-19 vaccines, as reported by the New York Times. Makary also faced criticism from anti-abortion activists who felt he had not done enough to oppose the approval of the abortion pill mifepristone. Furthermore, The Wall Street Journal reported he was also criticized for lacking flexibility when it came to evidence demonstrating that treatments for rare diseases work.

Makary leaves behind a mixed legacy. According to an opinion piece written by Matthew Herper in Stat, Makary was the “worst FDA commissioner in 25 years” and struggled with the political, organizational, and scientific aspects of the job, and even with his best ideas often faced execution challenges. Yet at the same time, the piece credits Makary with encouraging the use of artificial intelligence in drug development, expediting the drug review process by reducing dead time as companies wait for responses from reviewers, and accelerating clinical trials.

Administration leaders are planning to conduct the search over “the next several weeks,” according to a source familiar with the process who requested anonymity, according to an article in Stat. President Trump told reporters on Tuesday that there is no shortage of candidates for the job and that “everybody wants that job; it's a very important job.”

In other news, Energy and Commerce Committee Democratic leaders wrote to HHS Secretary Robert F. Kennedy, Jr. raising concerns over the “suppression of scientific data demonstrating the safety and efficacy of COVID-19 vaccines.” The letter cites a report alleging that FDA withdrew studies finding COVID-19 and shingles vaccines were safe, according to a committee news release.

Drugs and Biologics

FDA on Wednesday approved an oral combination of decitabine and cedazuridine tablets with venetoclax for treating newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that prevent the use of intensive induction chemotherapy.

The agency also released minor updates to five guidances covering the development of painkillers. The documents include: Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework, Development of Non-Opioid Analgesics for Acute Pain, Development of Local Anesthetic Drug Products With Prolonged Duration of Effect, Stimulant Use Disorders: Developing Drugs for Treatment, and Development of Non-Opioid Analgesics for Chronic Pain.

The agency has issued an untitled letter to BeOne Medicines USA in Pennington NJ related to its “false or misleading” advertising for Brukinsa (zanubrutinib) capsules for treating chronic lymphocytic leukemia.

FDA has announced a generic drug science and research initiatives public workshop on 8-9 June to discuss the status of science and research initiatives for generic drugs and provide an opportunity for public input on these initiatives.

The Duke Margolis Institute for Health Policy has announced a meeting on ReVAMPing the Pharmaceutical Supply Chain: Creating a Reliable Domestic Supply on 19 May.

Medical Devices

On Tuesday, FDA announced that it has stopped using the Quality System Inspection Technique (QSIT) for device inspections and began using the inspection process covered in the updated Inspection of Medical Device Manufacturers Compliance Program: 7382.850. In addition, after 2 February 2026, FDA said it will no longer use the following documents: Inspection of Medical Device Manufacturers (7382.845) and Medical Device PMA Preapproval and PMA Postmarket Inspections (7383.001). The updated inspections under Quality Management System Regulation (QMSR) describes the QMSR inspection process, and updates regulatory procedures and program contacts.

FDA announced a series of improvements to the eMDR System that will take place over the next two years. The schedule for these enhancements includes the announcement of upcoming enhancements in June, the release the implementation package in August, the deployment of enhancements for pre-production (ESG NextGen Test) in September, and the launch of “high-impact enhancements” to production seven months after the implementation package is released.

On Tuesday, FDA’s Center for Devices and Radiological Health (CDRH) announced that AVID Medical has issued an urgent medical device recall of its Namic RA syringes included in convenience kits. The recall affects 11 kits. There is a possibility that the syringe rotating adaptor on affected devices may unwind during use, resulting in a loose connection or full disconnection between the syringe and manifold. If unwinding occurs, there is potential for biohazard exposure, blood loss, and infection.