By Maaisha Osman, Inside Health Policy, October 23, 2025
As the Trump administration aims to speed up drug approvals through the FDA’s new Commissioner’s National Priority Voucher program, some critics from the “Make America Healthy Again” movement argue the push could fuel overprescription of medicines, weaken scientific standards and put patient safety at risk.
At a roundtable hosted by the MAHA Institute roundtable Tuesday (Oct. 22), Chris Masterjohn, a nutritional expert aligned with MAHA goals, told Inside Health Policy FDA’s accelerated approval programs carry a risk that prescriptions supported by limited evidence will reach patients. “There are ways to mitigate that risk,” he said, “but given the concentration of corporate power, that will be difficult.”
The MAHA Institute think tank was founded to support HHS Secretary Robert F. Kennedy Jr. and President Donald Trump’s health policies. Masterjohn argued MAHA advocates should aim to change how FDA approval is perceived by doctors and patients.
“Everyone assumes that if the FDA has approved something, it’s safe, effective, and good to prescribe,” he said. “We need to target that perception to prevent overprescription.” He added that accelerated approval programs can work if they are accompanied by clear communication and cultural shifts in prescribing habits. “We have to be very clear about what these approvals mean, and create a culture where these medications are not the first resort,” Masterjohn said.
At a panel during the Tuesday roundtable, Maryanne Demasi, a Substack blogger and former fellow at conservative nonprofit group Brownstone Institute, said FDA now clears about 70% of new drugs through expedited programs that require less robust clinical testing. The Brownstone Institute is closely aligned with the MAHA movement’s goals, especially its views on vaccines and public health measures. Demasi was referencing an investigation by the Lever and the McGraw Center for Business Journalism, which analyzed all 429 drugs approved by the FDA between January 2013 and December 2022. The study found that 311 of those drugs, or 73%, were approved despite failing to meet the agency’s own core standards for demonstrating effectiveness. Demasi said the surge in fast-tracked drug approvals can be traced back to the Prescription Drug User Fee Act (PDUFA), which allowed pharmaceutical companies to fund much of the FDA’s review process.
FDA now offers four expedited approval pathways: fast track, breakthrough therapy, accelerated approval and priority review voucher programs, including the new one launched in June for companies supporting Trump’s policy proposals. “Since PDUFA came in, there are now four expedited pathways,” she said. “That’s why so many drugs are being pushed through these particular routes.”
Some outside the MAHA movement have also voiced concerns about FDA’s use of accelerated approval pathways, including the new CNPV program.
Diana Zuckerman, president at National Center for Health Research, told IHP that while she supports prioritizing review of high-impact products, the CNPV program risks doing more harm than good. “The CNPV program’s timeline seems much too short for the FDA to conduct a careful review —- especially considering the staffing cuts, retirements, and government shutdown,” she said. Zuckerman served as a senior policy advisor in the Clinton administration in 1995.
Zuckerman outlined several key risks of the program: first, that a faster process could allow unsafe or ineffective products to reach the market on the basis of incomplete data. Second, the rush to meet deadlines could lead FDA reviewers to reject products that might merit approval but whose data require deeper analysis. “Speed can be dangerous in both directions,” she said. Third, the new program could divert limited resources away from other critical FDA reviews, delaying or diluting their quality. And finally, she warned, it could “set a precedent that increases pressure for all reviews to speed up — and therefore be less careful. That’s already a problem,” she said. “Let’s not make it worse.”
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On Oct. 16, FDA announced it will fast-track review of nine drugs under the CNPV program, which incentivizes companies to make their products more affordable and take other steps in the “national interest.” The Commissioner’s National Priority Review program promises to accelerate drug reviews to as little as one to two months for companies that support national goals like affordability and onshoring, including by adopting Trump administration’s “most favored nation” pricing policy.
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Demasi argued the user fee system gives industry far more influence over regulators than the public realizes. “People defend it by saying it’s just a fee-for-service — that drug companies are paying the FDA to review their products,” Demasi said. “But it’s not that they get a seat at the table — they get to dictate the terms of what happens during the approval process, including how quickly approvals are done.” “They’re not innocent bystanders paying for a service,” she added. “They’re steering the process.”
Demasi pointed to vaccines like Gardasil, which she said was approved based on “surrogate endpoints” such as changes in cervical cells rather than direct evidence it prevents cervical cancer. “Abnormal cells in the cervix can resolve on their own,” she said. “They’ve never shown in clinical trials that the Gardasil vaccine can reduce cervical cancer rates.”
While Demasi has questioned the evidence behind Gardasil, a vaccinologist told IHP those claims omit key context and misrepresent decades of research. Jake Scott, a clinical associate professor in infectious diseases at Stanford University, said that although Gardasil was initially approved based on surrogate endpoints — prevention of high grade cervical lesions rather than cervical cancer itself — this approach is standard practice. “Cervical cancer can take 10 to 20 years to develop,” Scott noted, making it impractical and unethical to wait decades for trial results. “Preventing high-grade lesions is proven to prevent cancer.”
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Demasi also argued that such surrogate measures — also used in Alzheimer’s drug trials tracking amyloid plaque reduction — often fail to translate into real clinical benefits for patients. Amyloid drugs for Alzheimer’s have been controversial, with Kennedy recently criticizing the evidence. “We need to go back to doing thorough examinations of the science, not rushing drugs through these expedited pathways,” Demasi said.
Read the article in Inside Health Policy here.