Ann Witt, health counsel extraordinaire to Representative Henry Waxman(and who previously served as acting director of DDMAC and advisor to the Commissioner), is returning to the FDA to serve in the agency’s Office of Policy, Planning and Budget.
Does this mean Ms. Witt will fill Jeff Shuren’s shoes? (Jeff is currently serving as the Acting Director at CDRH.) That would give Ann the platform to address some of her favorite issues such as off-label communications, advisory committee operations, and the medical device review process. It’s also interesting to note that Ms. Witt was a key player in Dr. Kessler’s (failed) attempt to claim regulatory authority over tobacco.