A spokesperson for the FDA said the agency is “considering a wide range of options to support American innovation.”
FDA Commissioner Marty Makary is looking to lower user fees for companies that commit to conducting their drug development in the U.S. in a push he calls the agency’s “America-first agenda.”
“If your Phase I trial is not in the United States, maybe you should pay a higher user fee,” Makary told participants of the National Academies of Sciences, Engineering, and Medicine’s pharma supply chain resilience workshop last month.
In a statement to Endpoints News on Tuesday, a spokesperson for the FDA said the agency is “considering a wide range of options to support American innovation,” but did not confirm whether changes in the user fee structure are in the works.
Makary has previously proposed lowering user fees, telling stakeholders at the kickoff meeting for the renewal process in July that he wants to lower the barrier for smaller stakeholders: “small companies and individual investors and academics.”
Now, it appears the Commissioner wants to harness the user fee program to incentivize companies to reshore their clinical programs. “I want to see Phase I trials in the United States,” Makary said during his keynote address at the event.
“I want to see American pharmaceutical companies thrive and I want to see pharmaceutical companies that do business in the United States thrive,” he added, promising that the FDA will “do everything that we can to win that business back.” Improving the efficiency of the agency’s processes, he said, will be the key to that goal.
During his speech, Makary also took some digs at China, which he conceded “has a booming pharmaceutical sector” at present. “Right now, across all Phase I trials, China has launched 3x more Phase I trials last year than the United States,” he said.
The U.S.'s edge, he posited, is data integrity. “I’m not sure we can trust a Phase III trial done in China,” he said. “Do you trust the GDP numbers that come out of China? Why would you trust a Phase III clinical trial done in China?”
The user fee program allows the FDA to collect payments from companies looking to have applications reviewed. This scheme pays for nearly half of the agency’s budget but comes with the caveat that participating drug or device sponsors cannot ensure favorable decisions for their applications. Instead, they can hold the FDA to certain standards, such as reasonable response times and the ability to hold a specific number of meetings with the agency.
The next use fee cycle is set to begin in late 2027, but because of the complexity of negotiations and the often lengthy back-and-forth between the agency and companies, the renewal process for the program is slated to start this year.
