Through our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or Agency) that may affect the Agency's structure and stakeholder interactions. This week's updates are as follows:
- FDA announces "CEO Forums" listening tour
- FDA's plan to improve state importation programs
FDA's "CEO Forums" Listening Tour
FDA announced a six-city listening tour, called "CEO Forums," in which FDA leadership will meet with chief executive officers (CEOs) of pharmaceutical and biotech companies to gather their thoughts on how "FDA can modernize its regulatory framework to better support innovation and patient access to safe and effective therapies." FDA Commissioner Marty Makary, M.D., M.P.H., will lead the forums as will Principal Deputy Commissioner Sara Brenner, M.D., M.P.H., and Director of the Center for Biologics Evaluation and Research Vinay Prasad, M.D., M.P.H. To register for the forum, participants must have on file with the Agency at least one active (1) Investigational New Drug (IND) Application, (2) New Drug Application (NDA), or (3) Biologics License Application (BLA). Additional information, such as dates and cities, were provided in the announcement. The first forum will be held on June 5, 2025, from 3 to 5 p.m. at FDA's Silver Spring, Maryland location.
FDA's Plan to Improve State Importation Programs
Pursuant to President Trump's Lowering Drug Prices by Once Again Putting Americans First executive order, FDA announced "enhancements" to the Federal Food, Drug and Cosmetic Act's Section 804 importation program. The program permits "states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs to the American consumer, without imposing additional risk to public health and safety." As part of these enhancements, FDA will allow states and tribes to submit draft Section 804 importation program (SIP) proposals for pre-review and will provide opportunities for informal meetings to obtain initial feedback on the proposals before formal submission. FDA will also take the following steps to support state importation programs:
- Develop a user-friendly tool to help states create SIP proposals
- Provide states with options to streamline the proposal's cost savings analysis requirement and offer input on the information states may use in estimating cost savings
Furthermore, FDA expects to meet with interested states in the fall to discuss these actions and obtain feedback. The Agency describes the meeting as "a forum to exchange information that will make it easier for states to obtain authorization while protecting public safety."
Venable will continue to monitor all changes regarding FDA and report any critical developments. If you have questions on how the contents of this article may impact your or your business's interactions with FDA, please contact the authors today.