Rachel Roubein
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Rachel Roubein
@rachelroubein.bsky.social
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Washington Post reporter covering the Food and Drug Administration. Reach me securely on Signal: RachelRoubein.28
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Reposted by Rachel Roubein
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Pazdur, a longtime FDA employee, has taken issue with Commissioner Marty Makary's plans to reduce the number of research studies needed to justify more drug-related decisions — with Makary arguing just one study is sufficient.

Also has warned that new Trump drug voucher plan may not be legal.
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.
November 21, 2025 at 10:27 PM