Makary Tells Device Makers FDA Should Bring HIV-Era Urgency to Approvals

Food and Drug Administration Commissioner Marty Makary told medical device makers on Thursday that the agency should bring the urgency it applied to the first HIV/AIDS treatments in the 1990s to new drugs and devices, including those for Alzheimer's disease, Type 1 diabetes and cancer, RAPS reported.

Makary spoke at the Medical Device Manufacturers Association (MDMA) annual meeting in Washington in a session moderated by MDMA chief executive Mark Leahey. He said such products should be approved "without cutting corners on safety," according to RAPS. "Devices are potential cures and they are powerful treatments … that is what we want to see more of," Makary said.

Asked what had surprised him about government work, Makary said he was surprised that "you can actually get things done quickly." Among the achievements he cited was the approval of Otarmeni, a gene therapy for genetic hearing loss that RAPS described as a biologic-device combination product approved in 61 days.

Elsa and adverse event reporting

Leahey pointed out that the device industry was the first to build in AI capabilities. Makary said the FDA was the first U.S. agency to make an AI tool, called Elsa, available to employees, and that 90% of the agency's reviewers use it. Reviewers mostly use Elsa as a checklist to make sure an application is complete before reviewing it, which has cut initial screening from the standard 60 days to two minutes, he said, according to RAPS.

"AI will not make an approval decision, but our reviewers love it," Makary said. He announced that Elsa 4.0 is due for release next week.

Makary also pointed to the consolidation of the agency's adverse event reporting systems, which had been spread across seven platforms, into one. He said the move has saved $20 million, which is being reinvested in hiring scientists, RAPS reported. When it launched the unified FDA Adverse Event Monitoring System in March, the FDA said its seven legacy databases, including the MAUDE database for medical devices, cost about $37 million a year to operate, and that it expected to save about $120 million over five years. The agency said AEMS would contain real-time adverse event reports for all FDA-regulated products by the end of May 2026.

Staff cuts and competition

Makary acknowledged that cuts by the Department of Government Efficiency "did some damage to the FDA," though he said "there was some good there." He said the agency's IT department went from 1,500 employees to 700, which he said has allowed for better focus.

Asked about his top priority, Makary pointed to global competitiveness. "We have been getting clocked by China and Australia" on approvals, he said. He said it takes about 220 days to get an investigational new drug application approved in China after a pre-IND meeting, compared with up to 380 days in the U.S., and that the agency is "actively looking at" that process. RAPS noted that the administration's fiscal 2027 budget request proposes an optional expedited pathway for companies conducting IND studies in the U.S.