For Immediate Release
FDA Commissioner Marty Makary has announced his resignation after approximately 13 months leading the agency. Kyle Diamantas, the agency’s deputy commissioner for food, is stepping in on an acting basis, with a permanent nomination expected to follow.
Commissioner Makary arrived with a reform agenda that aligned with much of what the life sciences industry has long called for: faster approvals, streamlined clinical pathways, and a lighter regulatory hand. Those goals remain worthy. What proved elusive was their realization. In practice, approval timelines lengthened, review standards shifted unpredictably, and the regulatory certainty investors depend on became harder, not easier, to find. The agency approved just 46 drugs in 2025, among the lowest totals in a decade. What matters most now is that the next leader restores the consistency and predictability that drug developers, device manufacturers, and diagnostics companies need to make long-term investment decisions.
FDA uncertainty touches every corner of Ohio’s life sciences ecosystem, from the 9,200 jobs in our medical device sector at companies like STERIS, GE Healthcare, and AtriCure, to gene therapy programs at Andelyn Biosciences and Forge Biologics, to researchers and clinicians advancing next-generation treatments at Nationwide Children’s, Cincinnati Children’s, Cleveland Clinic, and OSU. Ohio’s life sciences sector directly employs nearly 64,000 Ohioans, supporting more than 206,000 total jobs and generating $66 billion in total economic output. That engine requires a functional regulatory partner.
China is making deliberate, well-funded investments to establish itself as a global life sciences leader in drug development, device manufacturing, and advanced clinical trial infrastructure. When the FDA is unpredictable or slow, sponsors move clinical trial sites and research investments to where the regulatory environment is more certain, easier to navigate, and more affordable. Ohio has world-class clinical research assets at OSU, Cleveland Clinic, Cincinnati Children’s, and Nationwide Children’s, but those assets must compete globally, and a dysfunctional FDA puts them at risk.
“Ohio is doing the work,” said Eddie Pauline, President & CEO of the Ohio Life Sciences Association. “But the global competition for life sciences investment, including from China, is real and intensifying. Our members need an FDA that is a reliable partner, not an uncertainty. We are hopeful this transition delivers that.”
OLS will monitor FDA developments, stay connected with our national partners at BIO, PhRMA, and AdvaMed, and keep our members informed as this transition unfolds.
About the Ohio Life Sciences Association
The Ohio Life Sciences Association represents more than 300 member organizations across biotech, pharma, medtech, diagnostics, digital health, and advanced manufacturing. OLS drives innovation and economic growth by convening, advocating, and accelerating Ohio’s life sciences ecosystem.
Media Contact:
Natalie Monroe
nmonroe@ohiolifesciences.org
