FDA leader touts achievements of first 100 days; NIH will cap publishing fees while disseminating research results

The U.S. Food and Drug Administration’s (FDA) leader said “gold-standard science, transparency and common sense” have been the guiding principles for his first 100 days in office.

FDA also published new information to explain the its review process for new medicines. Government-funded research also will be disseminated, but at lower costs to taxpayers in the future, according to the chief of the National Institutes of Health (NIH).

FDA Commissioner Marty Makary, MD, MPH, and NIH Director Jay Bhattacharya, MD, PhD, announced the respective developments as part of the initiative to Make America Healthy Again, led by Health and Human Services Secretary Robert F. Kennedy, Jr., in the administration of President Donald J. Trump.

At the FDA

Martin Makary, MD, MPH
_{© U.S. Food and Drug Administration}

On July 10, Makary issued a news release recounting his first 100 days leading that agency, which he said regulates products that make up 20% of all U.S. consumer spending.

“I came here with big questions: Why does it take ten years for a drug to reach patients? How can we fix America’s food supply so it is not filled with harmful chemicals and additives? Why are childhood chronic diseases so prevalent?” Makary said. “We are taking bold action to address these big, obvious problems, and more, which have been staring at us for years.”

Key efforts include:

• Fixing America’s food supply, by improving infant formula, phasing out petroleum-based food dyes, and reviewing food chemical additives and ingredients currently “generally recognized as safe.”
• Accelerating cures, by reducing animal testing and employing alternative, more effective testing methods, including international data and advanced computer simulations. There is a new pilot program to reduce the drug review process from up to 12 months, down to one or two months. The COVID-19 vaccine regulatory framework has been revised to use a risk-stratified approach, instead of one-size-fits-all.
• Gold-standard science and administrative initiatives range from combating illegal e-cigarettes imported from China, to examining safety of talc, to streamlining the process for importing safe prescription drugs from Canada.
• FDA also is embracing artificial intelligence with a pilot project to use AI as for scientific review. Elsa is FDA’s new generative AI tool for staff to work more efficiently.

Makary noted he outlined his leadership priorities in a JAMA article and the agency has created the new “FDA Direct” channel on YouTube to post “timely and frank discussions” about current events at the agency.

Publishing NIH research

Jay Bhattacharya, MD, PhD
_{© National Institutes of Health}

NIH announced plans to cap how much publishers can charge NIH-supported scientists who want to make their findings publicly accessible.

“Creating an open, honest, and transparent research atmosphere is a key part of restoring public trust in public health,” Bhattacharya said in a news release. “This reform will make science accessible not only to the public but also to the broader scientific community, while ending perverse incentives that don’t benefit taxpayers.”

Currently, some major publishers charge as much as $13,000 per article for immediate open access, while also collecting subscription fees from government agencies, according to NIH. The agency’s news release did not name specific publishers, but said one group reportedly receives more than $2 million a year from NIH, while collecting tens of millions of dollars through article processing charges.

The cap on allowable publication costs will start in fiscal year 2026 to curb excessive article processing charges and disseminate findings without unnecessary financial barriers, according to NIH plans.

Drug research published

Scientific research is at the heart of an FDA decision to publish the first cache of complete response letters (CRLs) with agency comments on new drug applications and biologics license applications from 2020 to 2024.

The move is “a significant step in the agency’s broader initiatives to modernize and increase transparency,” an FDA news release said. Drug makers can learn from each other’s applications and avoid making mistakes, and the public has greater insight into the FDA’s decision-making process, the news release said.

FDA previously refrained from publishing the CRLs for pending applications. That led to applicants misrepresenting the rationale of FDA’s decisions to their stakeholders and the public, the news release said.

“For far too long, drug developers have been playing a guessing game when navigating the FDA,” Makary said in the news release. “Drug developers and capital markets alike want predictability. So today we’re one step closer to delivering it to them, with an ultimate goal of bringing cures and meaningful treatments to patients faster.”

The first cache of letters had more than 200 downloadable .PDF documents at open.fda.gov. Trade secrets and some commercial information is redacted from them. It is the first centralized database of past CRLs, and there will be more to come, according to FDA.