Makary Touts Hiring Push, Clinical Trial Reforms at FDLI
FDA commissioner Marty Makary says the agency is undertaking a major hiring push and a series of operational reforms aimed at strengthening its scientific workforce, modernizing inspections and reversing what he described as a loss of U.S. leadership in early-stage drug development. Speaking at the Food and Drug Law Institute annual meeting in Washington, DC 5/6, Makary said the agency is in the process of hiring roughly 3,000 scientists, with about 1,000 already onboarded. The effort, he said, is designed to support a “very aggressive and bold reform agenda” across regulatory programs.
The hiring initiative comes as the FDA has faced sustained staffing pressures in recent years, driven by a mix of retirements, pandemic-era burnout and reductions in force through government downsizing last year under the Trump Administration. Media reports have pointed to elevated attrition across review divisions and inspection staff, raising concerns about the agency’s capacity to meet review timelines and conduct routine oversight. Against that backdrop, Makary framed the hiring surge as a reinvestment in core scientific functions needed to execute new policy initiatives.
Among those initiatives is a pilot program for one-day “screening” inspections of manufacturing facilities (see earlier story). Under the model, FDA investigators conduct abbreviated inspections for facilities deemed low risk — potentially identified using artificial intelligence tools — with the option to extend inspections if safety concerns emerge. “We can do a one-day screening inspection,” Makary said, adding that the approach is intended to deploy inspection resources more efficiently while maintaining safeguards.
Makary also emphasized broader concerns about U.S. competitiveness in drug development, particularly in early-stage clinical research. He noted that China has overtaken the U.S. in Phase 1 clinical trial activity in recent years, with significantly faster timelines for initiating studies.
To address that gap, FDA is pursuing what Makary described as a “massive initiative” to streamline investigational new drug (IND) and Phase 1 processes. Planned changes include reducing non-safety-related data requirements in IND submissions, issuing clearer guidance on what information is not needed, and improving sponsor communication to reduce what he called “guesswork” in regulatory interactions.
The agency is also examining structural bottlenecks outside its direct control, including institutional review board (IRB) timelines and hospital contracting practices, which Makary said can delay trial initiation. He indicated that HHS may play a role in encouraging more efficient IRB processes, including greater use of centralized review models.
Makary set an ambitious target of compressing the timeline from pre-IND consultation to IND submission to as little as three to six months in pilot programs, compared with current timelines that can stretch to roughly a year in the U.S.
In parallel, the FDA is piloting real-time clinical trial monitoring using cloud-based data systems, allowing regulators to observe safety signals and endpoints as trials are underway. Makary said the approach could reduce what he characterized as “dead time” between trial phases and regulatory decisions—estimated at roughly 45% of the overall development timeline.
The real-time model could also improve transparency, he said, particularly around the reporting of negative trial results. FDA has recently advised companies of its plans to begin issuing Warning Letters to companies that fail to disclose unfavorable data, underscoring concerns about incomplete evidence reaching clinicians and patients. An internal FDA analysis found that 29.6% of trials likely subject to mandatory reporting requirements have not submitted results (see earlier story).
Taken together, the hiring surge and policy initiatives reflect a broader effort by FDA leadership to modernize regulatory processes while addressing internal capacity constraints and external competitive pressures.
“We want to be very competitive,” Makary said, “while maintaining our promise to safeguard the public by focusing intensely on safety.”