Fireside with Califf

Three months into his tenure as FDA Commissioner, and less than six months ahead of an election that could start the transition to his successor, Robert Califf is making progress on must-do priorities and trying to advance some big picture goals. Must-do items include finalizing renegotiation of PDUFA, meeting legal requirements for determining how FDA will regulate tobacco products and implementing the Food Safety Modernization Act.

In a fireside chat with BioCentury at the BIO International Convention, Califf discussed progress on several priorities for drug regulation, including addressing a mismatch between FDA's decades-old policies on regulation of speech about off-label uses of approved medical products, and contemporary judicial interpretations of free speech protections under the First Amendment of the U.S. Constitution...