Health Brief from The Washington Post

PUBLISHED BY

By Megan R. Wilson

Listen to this briefing

Not a subscriber? Sign up here to get this newsletter in your inbox.

The call is coming from inside the house: Top FDA drug regulator Richard Pazdur, who was appointed to the role earlier this month, has raised alarms about the agency’s various plans to expedite drug approvals, citing legal and safety concerns, The Washington Post reports in an exclusive story.
‘Moving goalposts’: Investors and pharmaceutical industry executives express frustration with uncertainty at a top drug regulator, while FDA moves to improve its communication.
Chart check: Take a look at how the staffing decline and workload increases at FDA could impact review times.

Good Friday afternoon and welcome to Health Brief. Keep in mind: The Health Brief newsletter will only be published on Monday next week. I’ll be returning to your inboxes on Dec. 1. Hope you have a wonderful weekend, and don’t forget to send in your Feedback Friday submissions. I’m all ears!

Do you have any other health policy tips, data points or intel? Let’s talk. You can find me at megan.wilson@washpost.com, or message me securely on Signal at megan.434.

This newsletter is published by WP Intelligence, The Washington Post’s subscription service for professionals that provides business, policy and thought leaders with actionable insights. WP Intelligence operates independently from TheWashington Post newsroom. Learn more about WP Intelligence.

FDA Commissioner Marty Makary speaks during a press conference at the Department of Health and Human Services. (Elizabeth Frantz/Reuters)


	The Lead Brief

Richard Pazdur, who recently took the helm as the top U.S. drug regulator, is questioning the legality — and safety — of multiple Food and Drug Administration initiatives to speed drug reviews and approvals, my Washington Post colleagues Dan Diamond and Rachel Roubein write in a scoopy Friday afternoon report.

The report — which draws on conversations with three people familiar with the matter granted anonymity to discuss the private deliberations — details three new FDA efforts that’ve drawn scrutiny from Pazdur:

Single study review: An initiative from FDA Commissioner Marty Makary to decrease the number of research studies needed to justify more drug related decisions, which Makary has argued would allow the agency to be more responsive to new evidence. According to Dan and Rachel’s reporting, Pazdur believes multiple studies may be necessary in order to better protect public health.
National priority vouchers: Pazdur is concerned with a new FDA pilot program to give priority review vouchers to drug companies based on their investments in the U.S. or commitments to price the new medications a certain way — a key part of President Donald Trump’s plan to lower costs for patients and boost domestic drug production. He has told colleagues that the program — which claims to shorten the review time of drug applications to weeks — is not sufficiently transparent and could be illegal, my colleagues’ report.
Staffing concerns: Pazdur has also pushed back on Makary’s plans to exclude career scientists from matters that address political priorities, such as antidepressant medications, puberty blockers and psychedelics. People with knowledge told my colleagues that while the commissioner has questioned whether these scientists could be blocking the administration’s agenda, Pazdur argues their involvement is essential to ensuring safety of the review process.

Why it matters: This is happening as the FDA has been consistently rocked by turmoil this year amid layoffs, the departures of some senior staff and frustration from the drug industry. Pazdur has been at the FDA for more than 25 years, his recent appointment to lead the Center for Drug Evaluation and Research, or CDER, had been largely viewed as a stabilizing force for the agency.

→ Make sure to read Dan and Rachel’s story for all the details.


	Executive Health Brief

Meanwhile, outside concerns about the FDA are also spilling out into the open, with the pharmaceutical industry and investors critiquing the agency. Regulators have been plagued by an exodus of staff, increasing politicization — and what drug companies argue have been increasingly unpredictable requirements from reviewers.

Earlier this month, biotech company uniQure said it was “surprised” by feedback it received during a meeting with the agency: The FDA suddenly raised the expectations for what would be needed to submit its Huntington’s disease treatment for approval.

Why it matters: The issues have been hitting pharmaceutical companies, complicating their efforts to drum up financial backing. If there is uncertainty in the drug approval process, or shifting expectations, investors won’t want to finance certain efforts. For patients, staffing shortages and hurdles to complete clinical trials could mean fewer treatments.

What the agency said, according to uniQure CEO Matt Kapusta in a statement, is a “drastic change” from the guidance FDA gave the company last year. “This news is unexpected, and we are truly disappointed for people living with HD, who have no disease-modifying treatment options for this devastating disease.”

A recent report from financial services firm Raymond James, based on discussions analysts had with more than two dozen people, including industry experts and current and former FDA staff, echoed concerns about unpredictability at the agency.

“Companies are reporting what can be described as moving goals posts that result in delays and disappointments,” a group of analysts led by former HHS official Chris Meekins wrote in the report.

Meanwhile, the group No Patient Left Behind surveyed biopharmaceutical CEOs and executives who work with federal regulators, and found that 82 percent were “worried about the FDA’s ability to function.” In one instance, an executive said that staff departures from the agency had left knowledge gaps. “Not one reviewer has any clinical experience in our therapeutic category (a large category),” the unnamed chief executive responded to the poll.

The group shared these results in an open letter to Makary that garnered more than 200 signatures from researchers, executives, investors and consumers.

→ The Department of Health and Human Services pushed back against the critiques.

“We strongly disagree with the premise that FDA’s decisions are unpredictable. Regulatory requirements may evolve as new data emerge, but this reflects a rigorous, science-driven review process, not inconsistency,” said Emily Hilliard, a spokesperson for HHS. “Early feedback to sponsors is informative, not binding, and each application is evaluated on its own evidence and safety considerations,” she said.

MIXED RESULTS

I spoke with multiple people with pharmaceutical industry clients, some of whom echoed the assessments about the agency. The regulatory process — and the critiques about it — can be complex and nuanced.

Smaller and midsize biotech companies are bearing the brunt of the issues, because most of the trouble comes earlier in the review process for new drugs, and there are more of them trying to create novel treatments. Large companies have more resources and connections to handle roadblocks, the sources tell me.

Publicly, the FDA has been trying to increase its collaboration with the industry. Earlier this week, Makary announced a new pilot program within the Office of New Drugs at CDER which approves new medicines and over-the-counter drugs, allowing developers to ask agency officials for a “quick clarification” between official meetings during the drug development process.

“Numerous drug developers have told me that a quick touchpoint or clarification opportunity with the FDA team could spare them months of guesswork,” he said in a statement.

Makary appeared at an industry conference for generic drugmakers last month to talk about moving to streamline the process for the review of biosimilar medications — copies of expensive biologic drugs. The agency also rolled out a new pathway to approve personalized gene therapies for rare diseases.


	Numbers Game

One of the key issues the industry has faced is a delay in drug reviews and a decrease in approvals overall, according to the Raymond James report and an analysis from RBC Capital Markets. Some of this can be attributed to a decline in staff — including the departures of figures who held institutional knowledge about the agency and its processes.

I took a look at the staffing numbers for the two main drug and biologics approval offices within FDA — CDER and the Center for Biologics Evaluation and Research — over the last several years, compared to a part of their workload: applications from drug companies to kick off clinical trials in humans. (The technical term is a commercial investigational new drug, or IND, application.)

→ While there are other tasks taking up reviewers’ time, the commercial IND application is an important metric because it’s the first major regulatory step in bringing a drug to market.

Here are some charts that illustrate the discrepancy, created with help from our graphics reporter, Daniela Santamariña.

CDER’s workforce dropped more than 18 percent in fiscal year 2025 compared to the previous year. Meanwhile, applications from drugmakers to start clinical trials in humans increased by 8 percent during the same period.

CBER’s workforce dropped to roughly 1,149 in fiscal 2025, a more than 16 percent reduction compared to the previous year. The decrease occurs as applications from drugmakers to start clinical trials in humans increased 41 percent compared to 2020 levels.

The Raymond James report notes that even more staff are having to recuse themselves from reviewing drug applications because they’re in talks with pharmaceutical companies about going to work for them. In April, former FDA commissioner Scott Gottlieb said on CNBC that about 600 FDA employees had to recuse themselves to avoid the appearance of a conflict as they searched for jobs — a number I’m told has dropped as people have left the agency.

Andrew Nixon, an HHS spokesperson, said that Makary will continue to improve FDA transparency with industry and “find efficiencies” to support agency staff that reviews drugs.

“FDA Centers and Offices have made over 350 selections of reviewers and investigators, and those staff are coming on at an increasing pace,” he said, but did not respond to a request to provide more specificity about what types of roles had been hired.


	Jobs Report

The National Confectioners Association, which represents the candy industry, has added Julie Moss to serve as vice president of food safety and scientific affairs. She spent more than two decades working at the FDA’s Human Foods Program, including as director of the Office of International Engagement. The industry group also brought on Sarah Brandmeier from the Consumer Brands Association to serve as the director of nutrition policy and scientific affairs.