Dive Brief:

• A top Food and Drug Administration official responsible for overseeing drug reviews is reportedly retiring from the agency, adding to an exodus of senior staff who have either left or been forced out by Trump administration leadership.
• Jaqueline Corrigan-Curay, who serves as acting head of the FDA’s Center for Drug Evaluation and Research, will depart next month, according to reports from Endpoints News, Stat News and other publications.
• Corrigan-Curay became acting CDER director after Patrizia Cavazzoni left the position shortly before the Trump administration took office. A physician and lawyer, Corrigan-Curay joined the FDA in October 2016 and was appointed principal deputy center director at CDER in 2021.

Dive Insight:

The FDA’s leadership ranks have turned over significantly in the past six months. Several senior leaders, including the agency’s second-in-command, departed like Cavazzoni at the start of the Trump administration. Others were let go during layoffs that took place in April across the Department of Health and Human Services, which oversees the FDA.

Still more were forced out in apparent disagreements with Trump administration appointees, including Peter Marks, who led the FDA’s biologics office, and two of his deputies.

An HHS spokesperson did not return BioPharma Dive’s request for comment and it’s unclear who will take Corrigan-Curay’s place. According to a report from BioCentury, FDA Commissioner Martin Makary is considering naming former pharmaceutical executive Karim Mikhail, who he recently hired as a senior adviser.

The turnover is occuring as Makary and his boss HHS Secretary Robert F. Kennedy Jr. carry out significant changes to U.S. medical regulation. At the FDA, Makary has set stricter approval standards for COVID-19 vaccines, ordered the rapid adoption of a new artifical intelligence tool and rolled out a new program to more quickly review drugs that support U.S. national interests. He’s also directed the agency to begin phasing out requirements that drugmakers conduct toxicology tests in animals.

The workforce carrying out these new initiatives is substantially smaller than what it was previously. The April layoffs, along with prior moves by the Trump administration to force out staff, have left the FDA with about 20% fewer employees, although there has been no official accounting of how many jobs were cut.

FDA leaders have said the layoffs aren't impacting drug review timelines. At a Senate hearing last month, Makary testified that the "trains are running on time." Still, a handful of companies have reported unexpected delays in agency decisionmaking, and last week one was told "resource constraints" were the reason why.

Makary is currently conducting a “listening tour” with two of his top deputies to meet with pharmaceutical and biotechnology company executives. Notably, when the tour was announced in late May, no official from CDER was listed as participating alongside Makary and the two other leaders.