The FDA will seek external review of its Food Safety and Tobacco offices, Commissioner Robert Califf announced Tuesday. The announcement is most likely a reaction to scrutiny over the handling of certain tobacco and food matters – specifically its regulation of e-cigarettes and infant formula.
Califf did not cite specific concerns, but stated that “the agency has confronted a series of challenges that have tested our regulatory frameworks and stressed the agency’s operations,” which prompted him to take a closer look at business operations.
The relevant offices will continue their work during the evaluation, including inspection activities, enforcement actions, and application review.
The Reagan-Udall foundation, an independent 501(c)(3) organization created by Congress to modernize FDA programs and regulations, will be working with an external group of experts on the evaluation and report its findings to FDA within 60 business days of initiation.