Makary Signals Push for Faster Approvals, and Sweeping Reforms

In a wide-ranging 4/1 address to employees at FDA, commissioner Marty Makary outlined an expansive agenda to accelerate drug approvals, lower costs, and modernize the agency — while maintaining its core commitment to safety.

Makary’s address (available recording), which coincided with his one-year anniversary at FDA, emphasized the agency’s broad mandate, noting the agency regulates roughly 20% of the U.S. economy, spanning everything from food and cosmetics to medical devices and prescription drugs. He framed the agency’s mission as both a public health and national security priority, with a growing focus on healthier food and faster access to medical innovation.

Central to Makary’s remarks was a push to shorten the traditional 10- to 12-year drug development timeline. While maintaining that safety remains FDA’s “number one goal,” he urged staff to challenge longstanding assumptions that delay promising therapies.

The agency, he said, is already making progress. FDA approved 67 new drugs last year — above historical averages — and achieved significantly faster review times. Some therapies have been approved recently in as little as 44 to 55 days after filing, particularly under the commissioner’s priority voucher pilot program that speeds decisions in cases where early clinical data showed dramatic patient benefit. Overall, average approval times dropped to roughly 310 days last year.

Makary also stressed the importance of early planning for advisory committee meetings to avoid delays near user fee deadlines, encouraging review teams to anticipate when external expert input may be needed.

As part of a broader modernization effort, Makary highlighted FDA’s internal artificial intelligence tool, “Elsa,” which helps reviewers analyze massive regulatory submissions. Though optional, the tool has been adopted by more than 90% of staff. He also outlined a sweeping vision for integrating AI and data systems across the regulatory lifecycle—from application review to inspections and post-market surveillance.

Makary also highlighted a more aggressive enforcement posture on direct-to-consumer pharmaceutical advertising. In the past year, FDA issued 72 enforcement letters targeting specific companies, along with roughly 1,500 broader notices to industry — marking a sharp increase from prior years. “Now I've personally noticed there are fewer ads and the side effects are more explicitly stated, and I think we are starting to see better compliance with the two regulations that generally have not been enforced. That is the regulation that ads have to have a fair balance of information for people, and they cannot create a misleading impression.”

FDA is also shifting its inspection strategy, with a significant increase in unannounced inspections — particularly at overseas manufacturing facilities. Makary criticized pre-announced inspections as ineffective and said the agency is rebalancing oversight to ensure more rigorous, surprise inspections globally. He added that AI is being deployed to identify high-risk facilities and improve inspection targeting. The agency is also exploring shorter, one-day inspections as an initial screening tool, allowing regulators to expand reviews when problems are identified.

Beyond approvals, Makary described a comprehensive review of the entire drug development process, citing growing international competition — particularly from China, which now leads in early-stage clinical trials.

Among the reforms under consideration or underway:

• IND and early-stage reform: FDA is reevaluating outdated investigational new drug (IND) requirements and exploring ways to shorten the roughly 380-day pre-IND timeline.
• IRB modernization: Institutional review board delays — often a bottleneck in clinical research — could be addressed through faster timelines, greater use of central IRBs, or structural reforms.
• Continuous clinical trials:  agency is preparing pilot programs for real-time, “continuous” trials, allowing regulators to monitor safety and efficacy data directly from electronic health records and apply Bayesian statistical models.
• Rolling and parallel reviews: FDA plans to review manufacturing data before clinical trial completion and shorten application filing periods from months to days.

Makary said these changes are aimed at both improving patient access and restoring U.S. competitiveness in biomedical innovation.

Despite the push for speed, Makary emphasized the need for stronger post-market monitoring. He pointed to past safety failures, arguing that FDA should leverage big data to detect adverse effects much earlier after approval. “We should have eyes on every single drug immediately after it’s approved,” he said.

Looking ahead, Makary expressed optimism about breakthroughs in several areas, including treatments for type 1 diabetes, ALS, cancer, and autoimmune diseases, as well as the potential for a universal flu vaccine. He said FDA intends to play a more proactive role in identifying promising early-stage therapies and helping guide them through the regulatory process.

Throughout the address, Makary reiterated that scientific integrity remains central to FDA decision-making, with review teams retaining authority over approval decisions. “We want faster approvals, but grounded in gold-standard science,” he said.

Makary also devoted a significant portion of his remarks to internal workforce priorities, emphasizing that workplace culture and staff satisfaction are central to the agency’s performance. Noting that FDA has adjusted to its leaner staff contingent after thousands of employees were let go or voluntarily left over the past year, he said FDA has now reached “historic lows” in staff turnover, a key indicator of morale, even as natural attrition continues to support professional development. The agency is onboarding more than 2,000 new scientists, which Makary described as a healthy infusion of new perspectives. At the same time, he noted a sharp decline in industry-related recusals among staff — often a signal that employees are seeking outside employment —suggesting increased stability within the workforce.

He credited agency leadership for fostering a stronger workplace environment and said the FDA is investing more in employee engagement, compensation, and quality-of-life initiatives. These efforts, he said, are designed to retain talent while ensuring staff have the resources needed to execute an increasingly complex regulatory mission.

Makary also highlighted a major push to modernize FDA’s technology infrastructure, describing prior systems as fragmented and inefficient. The agency has consolidated dozens of separate platforms — including roughly 40 application portals — into unified systems, while also merging multiple adverse event reporting databases into a single interface. The overhaul is intended to improve usability and data accessibility, particularly after internal analyses showed that a majority of users abandoned adverse event reporting due to overly complex processes.

The new system, which allows near real-time access to safety data, has already increased public usage while reducing Freedom of Information Act requests for the same information. Makary said these efficiencies are expected to generate approximately $146 million in savings, which will be reinvested into scientific staffing and regulatory modernization efforts.

In parallel, FDA is accelerating efforts to digitize its vast archive of regulatory submissions, scanning millions of pages each week to eliminate reliance on paper records stored across multiple facilities. Makary said digitization will not only reduce costs and improve internal workflows but also enable the use of artificial intelligence and machine learning tools — pending sponsor consent — to enhance regulatory review and scientific analysis.