A key cancer research advocate warned lawmakers Wednesday (March 22) that the Trump administration’s hiring freeze and recent proposed budget cuts to the National Institutes of Health (NIH) could have a serious impact on the future of FDA’s recently launched Oncology Center of Excellence (OCE), and urged lawmakers to swiftly pass PDUFA VI as written.

The Trump administration released a budget blueprint March 16 that proposed cutting NIH funding by $5.8 billion, and called for industry to pay double the agreed-upon user fees in exchange for reforms intended to speed product entry to market. The proposal to reopen the agreed-upon user fee agreements prompted concerns from industry and lawmakers over what would happen to the agency should the agreements not be reauthorized by the September deadline.

In his testimony at a March 22 Energy & Commerce hearing on Prescription Drug User Fee Act VI reauthorization, Jeff Allen, president and CEO of Friends of Cancer Research, discussed the positive impact funds from user fees have had on FDA and its review process, saying the fees have helped “make the review process more predictable, efficient and accessible.” Allen urged lawmakers to swiftly reauthorize the new agreement.

Allen also said that Trump’s hiring freeze puts the development of OCE at risk, and criticized Trump’s recently released budget blueprint, which calls for a reorganization of NIH centers and institutes and cuts funding by $5.8 billion.

“The proposed cuts to biomedical research would put the brakes on the engines of discovery and jeopardize the development of new medicines for patients,” Allen said. “Holding the FDA budget authority at stagnant levels prevents progress on agency functions that are not covered by user fees. Among the challenges that have been exacerbated in the current environment is the implementation of the FDA Oncology Center for Excellence, an innovative approach and a new model for collaboration. The potential of a detrimental budget and the presence of the current hiring freeze put the OCE and so many other transformational opportunities at significant risk.”

Ryan Hohman, vice president of public affairs at Friends of Cancer Research, told IHP that the proposed cuts to NIH put programs that fall under the funding of the moonshot, including OCE, at risk.

“The Moonshot initiative relied on a stable funding of the National Institutes of Health as a whole, and those programs cannot operate independently of NIH. It’s broad picture thing. The moonshot was never intended to supplant NIH funding,” Hohman said.

OCE was formally launched in January, with Richard Pazdur tapped as its director. The center will coordinate clinical reviews of oncology drugs, biologics and devices across FDA’s drug, device and biologics centers, all of which reside within the Office of Medical Products and Tobacco. 

https://insidehealthpolicy.com/fda-week/cancer-research-advocate-trump-…