President Donald Trump on Wednesday evening signed into law a short-term government funding deal to end the longest shutdown in government history, which also includes several provisions for the FDA. The new law sets up another round of user-fee funding for over-the-counter drugs at the FDA through October 2030, and it also calls on the FDA to improve the process for companies looking to switch a prescription drug to a nonprescription, or OTC, drug. The broader funding agreement in the law, however, only lasts until Jan. 30, setting up the possibility of another showdown that could again disrupt many government operations. Under the new OTC provision, companies seeking an OTC switch can submit a
written request for a meeting with the FDA to talk through how to address potential risks, and what evidence and studies might be needed. |