The FDA has proposed cutting fees for early-stage companies conducting clinical development in the U.S. instead of abroad.
The proposal is designed to incentivize U.S. drug development by tacking on higher fees for those not running phase 1 trials in the country, according to a FDA and Industry Steering Committee meeting summary shared Dec. 2.
The FDA also introduced the idea of companies innovating abroad paying additional yearly fees after submitting an investigational new drug application, according to the agency's document.
The meeting centered on Prescription Drug User Fee Act (PDUFA) reauthorization negotiations and took place in early November. Representatives from the FDA’s Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research and the Office of the Chief Counsel partook on the federal side, while the biopharma industry was represented by seven BIO members, seven PhRMA members and three Consumer Healthcare Products Association attendees.
Industry participants asked the federal representatives why the plan focuses on user fees instead of harnessing efficiencies that could speed up drug development and reviews.
In response, the FDA said those efficiencies are “also of interest to the agency, but outside of scope of the PDUFA negotiations,” according to the federal document.
Biopharma leaders also asked for details about how the FDA would operationalize the fee incentives, such as criteria for lowered application fees, payment timing and the expected impact for small companies. The FDA said those aspects would be discussed in future meetings.
The meeting adjourned, closing the first week of PDUFA negotiation meetings. The federal agency said it would propose a plan for future discussions about the fee incentives proposal.
As of publication, the Department of Health and Human Services had not responded to Fierce’s request for comment regarding the proposal or any possible planned progress updates.
The proposal becomes public right as the nation’s top drug regulator, Richard Pazdur, M.D., takes steps to retire from his freshly tapped role leading up the CDER.
Pazdur was chosen to lead Nov. 11 after the CDER's former director George Tidmarsh, M.D., Ph.D., exited the agency in early November.
After reports of Pazdur's planned retirement broke Tuesday, BIO’s president and CEO John Crowley said in a statement that the “departure raises serious concerns about the repeated turnover in key leadership occurring at the FDA.”
“We need organizational strength and stability at the agency,” Crowley added. “This constant turmoil is undermining America's leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China.”
Just last week, a federal commission report identified “clear warning signs” that the U.S. is relinquishing its innovative edge, arguing that the nation needs to “reimagine the federal science enterprise” by streamlining funding and incorporating artificial intelligence into processes.
A few days prior, hundreds of industry leaders penned a letter to FDA Commissioner Marty Makary, M.D., about the importance of having a predictable regulatory agency, citing a survey in which 82% of biopharma respondents said they were concerned about the FDA’s ability to function.
Overall, CEOs worry that added volatility in an already high-risk industry will discourage overall investment in biotech innovation or drive it to other countries, according to the letter posted by the nonprofit group No Patient Left Behind.
Meanwhile, regulatory delays and higher development costs are increasingly encouraging sponsors to consider options outside of the U.S., the survey found.
Notably, the authors of the letter expressed strong support for the Pazdur CDER appointment, which is now in flux.