Makary’s priorities: Faster reviews, domestic manufacturing, and AI

US Food and Drug Administration (FDA) Commissioner Marty Makary said he wants to see the same sense of urgency given to Operation Warp Speed applied to the agency’s Commissioner’s National Priority Voucher (CNPV) program.

During a fireside chat at the CASSS Well-Characterized Biotechnology Products (WCBP) conference in Washington, DC on Wednesday, Makary also said that FDA plans to designate the first company in its PreCheck program this summer.

The CNVP program is “going great,” Makary said. “We’ve got to try new things. We have to try pilot this and see what we can do differently.”

Makary likened the voucher program to Operation Warp Speed, the initiative to quickly deliver COVID-19 vaccines during the first Trump administration. “We saw with operation Warp Speed we were able to get to a decision quickly. I would like to see the same level of urgency that we saw as a regulatory body with Operation Warp Speed, when people were dying of COVID.” He said that this same approach can apply to diseases across multiple areas, including neurodegenerative diseases, cancer, and other debilitating conditions.

Makary stated that the pilot program is primarily aimed at expediting the reviews of the chemistry, manufacturing, and controls (CMC) portion of submissions while the therapies are being tested in clinical trials.

“When clinical trial results are released, it seems inefficient to then revisit aspects of the application that should have been addressed during the interim phases of the Phase 3 clinical trials,” Makary said.

Yet there have been concerns raised about the CNPV program, which prioritizes FDA review of drugs deemed critical to national security, both internally at FDA and within industry. The Associated Press recently reported that some FDA officials have raised concerns about the legality and ethics of the program. (RELATED: This Week at FDA: Drug voucher program hits a snag. GOP targets abortion drug, and more, Regulatory Focus 16 January 2026)

“We need to challenge the assumption that it takes 10 to 12 years for a new drug to market, and we have to challenge the assumption that manufacturing has to be done outside the United States. We are really suffering from 35 years of globalists squeezing margins by moving manufacturing outside the United States, we are on a mission as part of the America First agenda to bring manufacturing back to the United States,” Makary said.

When asked to update workshop participants on the status of the PreCheck program, Makary said there are plans to designate the first company this summer.

The program was announced in August 2025 and is intended to streamline the agency's oversight of certain manufacturing facilities based on national priorities, to provide greater regulatory predictability, and to encourage the construction of domestic factories.

He added that “companies have to make decisions based on long-term factors in the marketplace and may not know what the climate is going to be like in five years or ten years, so when you have assurance that you will get manning going in the us quickly.”

Simon Hotchin, vice president of regulatory affairs at Amgen, noted that a common theme from the discussion is the need to front load assessments and asked where else such front loading could be brought to bear.

Makary stated that AI can also help expedite reviews and conduct initial processing of applications, which currently takes 60 days. “In the modern era, do we think that making patients wait for an additional 60 days because we have to make sure that the application is complete, where with modern technology and AI we can get that checked on in a day?”

Makary also noted that FDA was the first federal agency to roll out an agency-wide AI assistant with the launch of its ELSA tool last year and said that FDA’s scientific reviews “love” ELSA.

Makary added that AI and modeling can reduce the need for animal testing. “With animal testing, historically we always assumed that if we give something to a chimpanzee or a bunny rabbit before we give it to humans, we would get an answer as to whether it is dangerous or safe. I mean, we are not writing on stone tablets anymore. We’ve got powerful scientific predictive mathematical modeling. We’ve got computational modeling and AI powered computational modeling where the computer looks at the structure of the molecule and can predict how it will interact with receptors in the body and create a panel of toxicity.”

He said that using these modeling tools can shave six to nine months off the drug development timeline.

In April 2025, the FDA announced that it was loosening its requirement for animal testing of monoclonal antibodies (mAbs) and other drugs. In its place, FDA will seek to reduce, refine, and replace the animal testing requirement where appropriate using real-world safety data from other countries with comparable regulatory standards as well as with New Approach Methodologies (NAMs) such as artificial intelligence (AI)-based toxicity and cell line computational models and organ-on-a-chip systems. (RELATED: FDA seeks to reduce animal testing requirements for mAbs, other drugs, Regulatory Focus 11 April 2025)

Makary also said that FDA is taking further action to adopt AI by updating two FDA guidances to ease its oversight of general wellness devices and clinical decision support (CDS) software. (RELATED: FDA relaxes oversight of general wellness devices, CDS software, Regulatory Focus 7 January 2026)

“Basically, the nutshell of that is if it is consumer grade, we are going to get out of the way. You don’t need to come to the FDA … If it's medical grade, and you use this term in your marketing, we are going to want to see a validated data set.”

Makary’s priorities: Faster reviews, domestic manufacturing, and AI

Related topics

Recommended content

Welcome to the new RAPS Digital Experience