Drug Shortages, Hatch-Waxman Amendments Lead FDA’s 2025 Legislative Agenda

The FDA’s legislative wish list for FY 2025 includes proposals to protect drug supply resiliency, amend the Hatch-Waxman Act, and exercise greater control over recalls.

These proposals — provided in the agency’s recent agenda — rely on the agency’s $7.2 billion budget request. The spending request is $495 million over FY 2023’s allotment, amounting to a 7.4 percent increase.

Amidst the ongoing legal fracas over march-in rights, the FDA wants to end Hatch-Waxman’s three-year exclusivity provisions. The change would ensure that exclusivity is limited to situations where the new drug applicant is actually seeking it, where data support the hypothesized effect of the drug, and prevent information on new safety risks from blocking competition, the FDA said.

To read the whole story, click here to subscribe.

Related Topics