Yale and Harvard faculty question benefits of FDA's 'America First' user fee provisions

Yale and Harvard medical school faculty have voiced concerns about the latest FDA user fee agreement, which includes a set of "America First" provisions.

The provisions are designed to prioritize incentives for U.S.-based pharmaceutical companies, but the academics question whether the changes will actually benefit the FDA or American firms.

Their criticism underscores broader uncertainty about how the new fee structure might affect drug development funding and regulatory operations in the United States.

The discussion comes as the FDA prepares to negotiate the next user fee deal, a key source of funding for the agency's review processes.