By Josh Nathan-Kazis

Things aren't quite back to normal at the Food and Drug Administration, but the appointment late Tuesday of a longtime agency insider to lead the FDA's drug reviews is looking like a sign that the Trump-era turbulence is easing.

The U.S. Department of Health and Human Services said that the new director of the FDA's Center for Drug Evaluation and Research will be Dr. Richard Pazdur, who has worked at the agency for 26 years and has led a division that works to speed review of cancer treatments since 2017.

The CDER director is one of the FDA's most important and senior roles. The Trump administration's decision to hand it to a longtime health bureaucrat rather than a contentious outsider like Dr. Vinay Prasad, who leads the FDA's other drug review office, could be an indication of a softening of the White House's campaign against the agency.

The SPDR S&P Biotech exchange-traded fund, which has been on a tear in recent months and is now up 25% this year, was down slightly on Wednesday. The iShares Biotechnology ETF was up 0.5%.

The appointment of Pazdur "may signal a material change in the approach of Commissioner Makary and Secretary Kennedy," wrote Raymond James Healthcare Policy Analyst Chris Meekins in a late Tuesday note, referring to FDA Commissioner Dr. Marty Makary and Health Secretary Robert F. Kennedy Jr. "Up to this point, appointments have created significant uncertainty for patients and industry."

Even before he was confirmed as secretary of the U.S. Department of Health and Human Services, Kennedy made clear that he intended to wreak extensive disruption at FDA. In the lead-up to last year's presidential election, Kennedy posted on X that FDA staff should "1. Preserve your records, and 2. Pack your bags."

In his early months at HHS, Kennedy more or less made good on those threats, laying off FDA staff and removing top agency leaders. His appointments to lead the FDA, including Makary and Prasad, were largely outsiders known for their harsh criticism of the agency. Healthcare investors and biopharma companies rely on a consistent, predictable FDA when charting their strategies. The SPDR S&P Biotech ETF fell 16.4% between President Donald Trump's election in November 2024 and the end of June 2025.

CDER is responsible for making approval decisions on most new medicines aside from vaccines and certain complex treatments such as gene therapies, which are the purview of Prasad's Center for Biologics Evaluation and Research. The prior CDER director, Dr. George Tidmarsh, a former biotech executive, resigned in early November while under investigation after less than four months on the job. His predecessor, Dr. Patrizia Cavazzoni, resigned shortly before Trump's inauguration and is now an executive at Pfizer.

It may be that HHS wanted a steady hand after the turmoil of the brief Tidmarsh era, which was marked by allegations of political influence and ended in a messy public spat.

But on Wall Street, the decision seemed to be taken as a sign of a shift away from that aggressive focus on remaking the FDA that has characterized much of the first year of the second Trump administration.

Pazdur is well-known to biotech investors as the creator and director of the FDA's Oncology Center of Excellence, an office within the FDA that has worked to speed cancer drug approvals. Wall Street analysts were exuberant on Tuesday and Wednesday. Pazdur is "likely the best possible person for the role," RBC Capital Markets analyst Brian Abrahams wrote.

Meekins, in his note, raised the possibility that Prasad, a bomb-thrower who replaced industry favorite Dr. Peter Marks as head of CBER, may be falling out of favor. "One must now wonder whether the foundation under Prasad is cracking and if his days at the agency could be numbered," Meekins wrote.

The indications of a less-stormy course for the FDA could add fuel to the run-up in biotech stocks that has only accelerated in recent weeks. As worry over Trump's threats about tariffs and drug pricing have faded following White House deals with Pfizer, AstraZeneca, and other large drugmakers, investors have returned to the sector. The SPDR S&P Biotech ETF is now up more than 30% since the start of July.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.

(END) Dow Jones Newswires

November 12, 2025 13:47 ET (18:47 GMT)

Copyright (c) 2025 Dow Jones & Company, Inc.