FDA Less Aggressive with Off-label Promotion: Woodcock
In recognition of recent court decisions that have been protective of off-label promotion, CDER director Janet Woodcock has acknowledged that the pendulum has swung away from aggressive FDA drug advertising and promotion enforcement. Addressing an Alliance for a Stronger FDA gathering in Washington, DC 9/21, Woodcock was asked by former FDA chief counsel (Carter Administration) and current Williams & Connolly senior counsel Rich Cooper whether the agency has changed its approach to advertising and promotion enforcement what industry should expect going forward. “Well, I think that you've seen any enforcement that we do is really tied to the truthful and not misleading standard,” answered Woodcock, adding that enforcement actions typically will be tied to industry activities that are seen as a threat to public health and safety.
Woodcock pointed to a recent guidance document, Medical Product Communications That Are Consistent with the FDA-Required Labeling, that gives agency views on manufacturers’ communication of information that is not contained in the FDA-required labeling for their products, but is consistent with that labeling. She said FDA has reinterpreted “some of the things actually felt to be off label [promotion] before, such as descriptions of subgroups or secondary endpoints or patient appreciation studies and all the different things that companies do and they want to advertise about, but they are related to the approved indication. And so what we said about those is that it isn't off-label promotion where it is consistent with the approved labeling, even though it has information that goes beyond what is in the approved label, but it still should be truthful and not misleading.”
Asked by APCO Worldwide president and Alliance member Wayne Pines to further address the low number (four) of CDER Warning Letters issued this year on advertising and promotion violations and any different standard that the Office of Prescription Drug Promotion (OPDP) is applying, Woodcock said the agency is walking very carefully on these, and each one of those letters was a joint effort between the Office of Chief counsel and OPDP because of the First Amendment implication. “We are looking for ones where we really think there would be a threat to human safety or they are doing something egregious.” She said the agency is less interest in promotional activities such as where an acne drug is promoted to work faster than a competitor product. “Just let them duke it out,” Woodcock said. “We are looking at these things carefully, but we really have to recognize the current jurisprudence.”