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# Makary Reassures Stakeholders that FDA Remains Robust
- URL: https://www.fdaweb.com/makary-reassures-stakeholders-that-fda-remains-robust/
- Published: 2025-11-06T12:00:00.000Z
- Updated: 2026-09-14T15:25:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5160179

Despite recent departures among its senior ranks and turmoil caused by the ongoing government shutdown, FDA remains robust, according to commissioner **Marty Makary**, who spoke at the [Milken Institute’s 2025 Future of Health Summit](https://milkeninstitute.org/content-hub/event-panels/part-2-conversation-fda-commissioner-marty-makary-and-cms-administrator-mehmet-oz?ref=fdaweb.com) 11/6\. Makary emphasized a shift toward a more collaborative culture and outlined ambitious plans to accelerate drug development, streamline reviews, and influence healthcare costs.

Over the past year, several top officials have left the agency, including this week’s resignation of CDER director **George Tidmarsh** after being placed on administrative leave amid an internal ethics investigation and a defamation lawsuit tied to a public post criticizing a company’s drug ([see story](https://www.fdaweb.com/top-drug-chief-resigns-amid-misconduct-probe-lawsuit/)). His departure drew headlines portraying turmoil at the agency, but Makary reassured stakeholders that the agency’s work continues on schedule.

“The FDA is strong. The trains are running on time, hopefully faster now that we are going to cut the idle time, not cutting corners on safety, we’re cutting the idle time in the review,” Makary said. He added that all user fee deadlines and funding targets will be met despite recent staff changes and government shutdown challenges.

Makary has sought to dismantle what he described as a “fiefdom culture,” where the FDA’s six major centers operated largely independently. “The centers were running their own secret governments,” he said. “The commissioners were sort of put out to pasture. So we broke that up.” He emphasized there is a new “teamwork mentality” among the agency’s employees, noting that collaborative reforms have allowed FDA to pursue a broad agenda of drug review improvements. Over the next three months, the agency plans to announce a “bunch of drug reforms,” Makary noted.

A centerpiece of Makary’s vision is the Commissioner’s National Priority Voucher program, which identifies drugs with transformative potential and accelerates their review timelines. Unlike traditional accelerated review programs, which focus on public health priorities, Makary said the voucher program will prioritize drugs based on early-phase data, including promising results from animal and Phase 2 studies.

Makary indicated the voucher program could indirectly influence drug pricing, supporting the administration’s broader Most Favored Nation pricing initiatives. Six products — including treatments for cancer, sickle cell disease, obesity, and drug-resistant tuberculosis in children — were recently [awarded vouchers](https://fdaweb.com/login.php?sa=v&aid=D5160174&cate=&stid=%241%24hT0.WM4.%24kUVmkfB3bisUS3YwMf88c.&ref=fdaweb.com) under the program. “We’re not interested in 1% or 2% reductions in drug prices. We’re interested in massive reductions,” he said.

He also suggested reducing the reliance on animal testing, using computational modeling to shorten development timelines, and consolidating clinical trial phases (continuous trials) to avoid repetitive regulatory applications.

Makary underscored plans to monitor drugs more closely after approval using big data and real-world evidence, enabling rapid detection of safety or efficacy signals. The agency is also exploring closer collaboration with CMS on coverage decisions for newly approved therapies.

Makary framed these initiatives as essential to keeping the U.S. competitive in drug development amid growing international biotech activity, particularly in China and Australia, and to delivering transformative therapies to patients more efficiently.