FDA Seeks Faster IND-To-Approval Timelines, Expanded OTC Access
FDA is prioritizing efforts to accelerate drug development timelines beginning at the investigational new drug (IND) stage, while also pushing to expand over-the-counter (OTC) access and modernize regulatory processes, commissioner Marty Makary said Wednesday.
Speaking during a press briefing, Makary emphasized that the agency is rethinking the full drug development continuum — from IND clearance through final approval — with the goal of compressing timelines that have historically stretched a decade or more.
“We want to challenge the assumption that it takes 10 to 12 years for a drug to come to market,” Makary said, according to reporting by MedPage Today. “We believe it can be done faster without cutting any corners on safety.”
A key focus is reducing “idle time” between development stages, including earlier phases governed by IND applications, which allow companies to begin clinical testing. Makary said the agency is looking to use technology and operational reforms to streamline transitions from early clinical development through regulatory review.
FDA is also examining structural bottlenecks in the clinical research ecosystem, including delays caused by institutional review boards (IRBs), which oversee clinical trial approvals, according to MedPage Today. Makary noted that IRBs — often volunteer-run and meeting infrequently — can slow study initiation, sometimes taking more than a year for decisions.
“We can do better,” he said, suggesting potential reforms such as compensating IRB members to accelerate reviews and improve efficiency.
Global competition is another concern. Makary warned that the U.S. is falling behind China in early-stage clinical research, particularly in Phase I trial initiation, and said the agency is exploring ways to remain competitive while maintaining safety standards.
Among other topics, the commissioner also pointed to recent performance metrics, noting that FDA approved 67 drugs last year — above historical averages — and said the agency has recently achieved full compliance with Prescription Drug User Fee Act eview deadlines after missing some targets earlier in 2025, MedPage Today reported.
Beyond speeding approvals, Makary said expanding OTC availability is another major priority. He criticized some longstanding regulatory requirements as unnecessarily burdensome, particularly studies designed to show that consumers can understand drug labeling.
“When I look at the reasons those drugs were not approved in the past, I think we can do better,” he said. “We want to reduce the requirements that are onerous that don’t make sense, and focus instead on safety and labeling.”
Makary argued that broader OTC access could improve affordability and convenience, reduce unnecessary healthcare visits, and increase competition. He specifically pointed to vaginal estrogen as a candidate for potential OTC availability, citing growing demand for hormone therapies among postmenopausal women.
Finally, Makary addressed internal restructuring efforts, including consolidation of duplicative administrative functions across FDA centers. While he supported efficiency-driven changes, he acknowledged concerns about workforce reductions, noting that some scientific staff had left under early retirement programs even as the agency is now hiring to rebuild expertise.