FDA Commissioner Dr. Marty Makary declared that the agency will finally pull back the curtain on years of secrecy, releasing 89 previously unpublished drug decision letters and committing to real-time disclosure of future rejections.
For decades, Big Pharma and its allies inside the federal government have operated behind closed doors, burying critical information about why drugs were rejected, leaving the American people completely in the dark.
“If the FDA does not approve a drug application, the American public deserves to know why. Today, we are releasing a large batch of previously unreleased decision letters from 2024 to 2025. Going forward, we will release every new letter in real time,” Makary announced on X.
In an accompanying video, Dr. Makary, who has pledged to clean house at the FDA, stood behind his desk stacked with freshly printed decision letters and addressed the public directly.
Makary: “I’ve got on my desk FDA decision letters that we are going to make public today, and this is part of a broader transparency initiative we announced on day one. We’re doing this for a couple of reasons.
Number one: We want drug developers and inventors to understand exactly how the FDA thinks, and the division they’re applying through specifically, so they can better navigate the process. If somebody has a cure for a disease, they should be able to get through the process as efficiently as possible—with as much information as possible—on how the FDA works.
Number two: We’re doing it because, if the FDA does not approve a drug, the public deserves to know why. Sometimes people come up to me and say they heard a drug was not approved by the FDA for no good reason. Then, when I look into it, it turns out there were a lot of good reasons, including safety and manufacturing violations. So people deserve to have all the information.
We hope that this broader initiative is going to help deliver on our bigger goal of more cures and meaningful treatments for the American people.”
WATCH:
If the FDA does not approve a drug application, the American public deserves to know why.
Today we are releasing a large batch of previously unreleased decision letters from 2024 to 2025. Going forward, we will release every new letter in real time. pic.twitter.com/qiXkqP3H4d— Dr. Marty Makary (@DrMakaryFDA) September 4, 2025
According to the press release:
The U.S. Food and Drug Administration today announced that it will release future complete response letters (CRLs) promptly after they are issued to sponsors. The agency also released today 89 previously unpublished CRLs issued from 2024 to the present associated with pending or withdrawn applications. Each of these CRLs detail specific safety and effectiveness deficiencies identified by the FDA as preventing the application from receiving approval.
“This is a milestone day for the agency,” said FDA Commissioner Dr. Marty Makary, M.D., M.P.H. “By embracing radical transparency—one of the guiding principles of this administration—we’re giving invaluable insights to help speed therapies and cures to market, providing complete context to investors and shareholders, and above all, restoring public trust.”
Going forward, the agency will promptly release newly issued CRLs, and when approving applications will release all CRLs associated with that application. The agency will also publish batches of previously issued CRLs associated with withdrawn or abandoned applications. All CRLs will be redacted to remove confidential commercial information, trade secrets, and personal private information, but will contain company names.
Publishing CRLs offers important benefits for public health, including empowering drug developers to avoid common missteps and efficiently bring more cures and meaningful treatments to the American public; delivering greater insight to patients and the health care providers who treat them; and ensuring sponsors provide complete and contextualized information in communications to investors and shareholders.
The FDA recognizes the tremendous public interest in the transparency and credibility of FDA decision-making. The publication of all CRLs also complies with the President’s direction to all agencies, via Executive Order No. 14303, to release “data, analyses, and conclusions associated with scientific and technological information produced or used by the agency that the agency reasonably assesses will have a clear and substantial effect on important public policies or important private sector decisions.”
Decision letters are accessible to the public as a centralized dataset at openFDA.
The post Dr. Makary Says FDA Will Release 89 Unpublished Decision Letters for Transparency — Announces Real-Time Disclosure of Rejections After Years of Hiding Critical Drug Data from the Public appeared first on The Gateway Pundit.