April 25, 2016 — In a speech at the Alliance for a Stronger FDA’s quarterly meeting April 19, new Commissioner of Food and Drugs Dr. Robert M. Califf stated that the agency’s current priorities include determining when advertising is false or misleading and addressing labeling and patient/consumer communication, among others. He also indicated that the FDA has to collaborate with industry in order to be effective.
In an aside in the speech, Califf noted that he had just participated in an internal “off-label” meeting. He opined that the FDA’s current off-label policies were developed decades ago when physicians had far fewer sources of information and gathered and processed information differently, leading him to conclude that it was a good time to review and renew the FDA’s policies.
“It’s reassuring to hear Dr. Califf’s informal remarks suggesting that it’s time to modernize the FDA’s off-label policies,” said Coalition for Healthcare Communication Executive Director John Kamp. “Let’s all hope that the internal logjam obstructing the movement forward has broken, and that we will be hearing more from FDA soon,” he said. “Clearly it’s time for the FDA to take initiative away from the courts and to move forward. Doctors, patients and the industry have waited long enough.”
Califf also was quoted by Stat as stating that the FDA has to “be able to interface effectively with people that we regulate, which is extraordinarily touchy territory,” and that the agency has to balance the “sanctity of regulation” with being “fluent with the outside industry.”
In an earlier blog post for FDA Voice, Califf stated that the FDA “is thoroughly committed to working with the many partners in our ecosystem to help build and sustain an infrastructure that produces the high-quality, scientific evidence need to guide FDA’s decisions” about the products it regulates, “as well as the decisions that healthcare providers, patients and consumers make about their health and well-being.” In that March 30 post he also cited “improving product labeling” as one of the cross-cutting issues that “will benefit most from my attention and support.”