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# GLP-1 Crackdown, OTC Push and Faster Ph.1 Timelines: Makary
- URL: https://www.fdaweb.com/glp-1-crackdown-otc-push-and-faster-ph-1-timelines-makary/
- Published: 2026-02-18T12:00:00.000Z
- Updated: 2026-09-14T13:33:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160688

FDA commissioner **Marty Makary** says the agency will step up enforcement against unlawful mass compounding of GLP-1 weight-loss drugs, pursue an aggressive agenda to move more medicines over the counter, and accelerate early-stage clinical trials in the U.S.

[Speaking to CNBC](https://www.cnbc.com/2026/02/18/fda-chief-marty-makary-more-drugs-should-be-over-the-counter.html?ref=fdaweb.com) at a policy event in Washington, DC 2/17, Makary said FDA is “serious about cracking down” on companies that market compounded versions of GLP-1 drugs outside the parameters of federal law. Companies that compound versions of those products must comply with Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, he said, adding that the agency has seen violations.

The FDA plans to target mass marketing claims and the importation of active pharmaceutical ingredients (APIs) that are not FDA-approved. The agency is also communicating directly with firms it believes are operating outside regulatory guardrails, he said.

Makary expressed hope that 2026 could mark the end of unlawful large-scale compounding of GLP-1 drugs, particularly as shortages of branded products have eased. He said some compounders are now sourcing APIs from companies such as Novo Nordisk and Eli Lilly, adding that competition is welcome so long as firms operate on a “level playing field.”

Makary also outlined a priority to move more prescription drugs to over-the-counter (OTC) status, citing vaginal estrogen products, anti-nausea medications, and naloxone as examples under evaluation. He questioned whether certain medications still warrant prescription-only status in a “modern, sophisticated world,” arguing that greater OTC availability could improve access and enhance price transparency.

The commissioner linked the OTC initiative to broader Trump administration efforts to reduce drug prices, including “most favored nation” pricing policies advanced by the Centers for Medicare and Medicaid Services and reforms targeting pharmacy benefit manager practices.

Makary pointed to recent Department of Labor actions aimed at increasing transparency in PBM “spread pricing,” describing excessive markups as price gouging. He argued that shelf pricing in an OTC market can, in some cases, undercut insurance copays and limit opaque pricing dynamics behind the pharmacy counter.

He said the FDA is pursuing rulemaking and monograph changes to facilitate OTC switches and suggested that, in principle, drugs should be available without prescription unless they present safety risks requiring laboratory monitoring, carry abuse potential, or pose other significant hazards.

Additionally, Makary warned that the U.S. has fallen behind China in early-stage drug development. He said that in 2024 China conducted more than 2,800 Phase 1 trials compared with roughly 800 in the U.S., reversing a historical advantage.

To restore competitiveness, Makary called for reform of hospital contracting processes, Institutional Review Board procedures, and the pre-IND-to-IND pathway governing first-in-human studies. He said the current U.S. timeline — about 520 days from pre-IND to IND clearance — lags China’s timeline of just over 200 days.

“We need giant, big ideas,” he said, suggesting the FDA may explore partnerships with health systems and academic medical centers and reevaluate longstanding IND information requirements.

Makary framed the effort as bipartisan, saying the goal is to reduce unnecessary red tape while maintaining scientific rigor to accelerate development of “more cures and meaningful treatments” for patients.