Top FDA drug regulator raises alarms about expediting approvals

[mahatmakanejeeves]

Source: Washington Post

WP Exclusive
Top FDA drug regulator raises alarms about expediting approvals

Richard Pazdur, who assumed his new role this month, has warned that new Trump administration initiatives could be illegal and pose a risk to public health.

November 21, 2025 at 5:17 p.m. EST
6 min


Richard Pazdur, a longtime Food and Drug Administration official, testifies at a 2011 event. (Bloomberg/Getty Images)

By Dan Diamond and Rachel Roubein
https://www.washingtonpost.com/people/dan-diamond/
https://www.washingtonpost.com/people/rachel-roubein/

The newly installed top U.S. drug regulator has raised concerns about the legality and pace of initiatives to expedite drug decisions, arguing they could threaten Americans’ safety, according to three people familiar with the matter who spoke on the condition of anonymity to detail private deliberations.

Richard Pazdur, an oncologist and longtime Food and Drug Administration official who was announced for his new role on Nov. 11, has questioned several plans developed by FDA Commissioner Marty Makary, warning that they could pose a risk to public health, the people said. His concerns, which have not previously been reported, represent the latest flash point at an agency rocked by turmoil this year amid layoffs and the exits of some senior staff. Industry groups this week also appealed to President Donald Trump, saying that FDA’s regulatory decisions had become erratic and unpredictable, casting a shadow over the agency’s drug approvals and creating uncertainty for patients.

Pazdur and Makary have disagreed over the commissioner’s plan to reduce the number of research studies needed to justify more drug-related decisions, such as changes to drug labels, two of the people said. Makary has argued his plan to reduce the burden of proof to a single study would allow the agency to more quickly respond to new evidence. Pazdur has countered that multiple studies may be necessary in many cases and would better protect public health.

Pazdur has also raised concerns about Makary’s new drug-review program, which has been part of Trump’s push for lower drug prices and efforts to boost domestic manufacturing. Pazdur told colleagues the program — which allows the agency to significantly shorten review times and expedite approvals for treatments that are aligned with the country’s health priorities — is not sufficiently transparent and could be illegal, the people said. The Trump administration has partly leaned on the program as it seeks to strike deals with drug companies to voluntarily cut their prices in exchange for quick drug approvals and other benefits.

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By Dan Diamond
Dan Diamond is a White House reporter for The Washington Post, with a focus on policy and public health. His email is [e-mail] and you can reach him on Signal at @dan_diamond.01.follow on X@ddiamond
https://www.washingtonpost.com/people/dan-diamond/

By Rachel Roubein
Rachel Roubein is a national health-care reporter for The Washington Post covering the Food and Drug Administration. Reach her securely on Signal: RachelRoubein.28follow on X@rachel_roubein
https://www.washingtonpost.com/people/rachel-roubein/

No link yet.

[bucolic_frolic]

1. He's not going to have that job long. /nt

[Irish_Dem]

2. I never realized there were so many ways to kill Americans.

Without firing a shot.

[groundloop]

3. Look at how many people tRump killed because of his mismanagement of the Covid pandemic

I've seen numbers ranging from 1/4 million a million preventable deaths.

[Irish_Dem]

5. Killing 1 million Americans is no small feat.

I am certain Trump wants to beat his prior kills score.

[snot]

4. I thought part of the objection to the mrna Covid vaccines was

that they'd been rushed into use without adequate testing?

[moniss]

6. He will be sidelined because

some people need to get all of those "additional uses" for Ivermectin approved so they can make good on their previous speculation.