Senate Expands Infant Formula Safety, Supply Workload For FDA, Industry In User Fees Bill

HELP Committee passes five-year reauthorization of FDA drug, medical device and biosimilar user fees with separate provisions expanding agency’s authority to regulate infant formula manufacturing and marketing and establishing Office of Critical Foods in CFSAN.

Senate legislation not only would impose a requirement for infant formula firms to report production disruptions to the US Food and Drug Administration, but also require the agency to expand its regulation of the formula space and establish an office focused on the market.

The agency isn’t telling Capitol Hill yet that a formula shortage across the US has been eliminated, though.