Reverse FDA Restructuring: Former GOP Representative
Former Rep. John Doolittle (R-CA) says the restructuring underway at FDA, while well-intentioned, risks “undermining the very innovation and domestic capacity the president seeks to promote.” Writing for The Hill, Doolittle, who served on committees with FDA oversight, says the elimination of 3,500 full-time FDA employees, many of them senior scientific and experienced regulators, affects institutional memory and “risks hobbling the expedited pathways the small biotech firms rely on to deliver therapies for rare and life-threatening diseases.”
He cites media accounts of biotech companies that have had to delay or cancel clinical trials due to a lack of timely guidance from FDA or have approached European regulators to be able to move forward with a trial. He says other companies have reported receiving conflicting and confusing feedback from inexperienced agency staff or no response at all for time-sensitive requests.
“I have long supported targeted reforms to make the agency more nimble and responsive,” Doolittle writes. “But there is a fine line between streamlining operations and cutting the institutional capacity necessary to do the job. Removing experienced drug reviewers before an adequate backup plan can be put into place not only jeopardizes U.S. safety standards but also undermines our competitive edge.”
The article notes that since 2014, the number of biomedical drugs under development in China has increased twelvefold, while innovation in the U.S. has remained relatively flat.
If trends continue, Doolittle says, China could match or surpass the U.S. in biomedical innovation within the decade. “We have seen this movie before,” he says, “in semiconductors, in telecommunications, in clean energy. We cannot afford to let biotech go the same way.”
Doolittle concludes that President Trump’s vision for American self-reliance will only succeed if it is built on a foundation of regulatory compliance and stability. “Swift actions should therefore be taken to restore FDA’s core functions, rehire critical staff, and unfreeze the hiring of roles essential to America’s leadership in biomedical science. The stakes — for patients, for innovation, and for national security — are simply too high to ignore,” he says.