This post was written by SmartBrief’s Elizabeth Collins.
The pharmaceutical companies that say they are waiting for the Food and Drug Administration to issue new guidance on how to handle drug promotion through social media are just using the FDA’s guidance delay as an “out,” or an excuse, said Glenn Byrd, MedImmune’s director of regulatory affairs, at the Marcus Evans “Social Media for Pharma” conference in Washington, D.C., on Thursday.
Some in the industry feel that when the FDA finally issues its social media guidance, answers to all their questions will suddenly become clear, he says. He doesn’t think that will be the case. He points to what we already know, however, which should be enough to get companies started.
The FDA will regulate anything a pharmaceutical company does to generate interest in its products, and Byrd reminded the audience that the FDA has already made clear what its expectations are in regards to advertisements and promotions. “There’s already guidance out there from the FDA,” he said, highlighting the May 2009 draft the agency issued, “Presenting Risk Information in Prescription Drug and Medical Device Promotion,” among others.
Byrd hammered home the point that no matter what the medium, there are certain core requirements companies must meet to comply with FDA regulations. Content can’t be false or misleading; it has to fairly balance the information it presents on effectiveness with what it presents on risks; and it must reveal “material facts,” or tell the whole story.
“My advice is sticking to the fundamentals,” Byrd said.
Other panel members speaking at the same session echoed Byrd’s sentiment that the FDA isn’t likely to radically change its course just because social media advertisements don’t come on paper that patients can hold in their hands. In discussing online content, Sanofi-Aventis U.S. acting head of U.S. regulatory affairs for marketed products Mark Gaydos noted, “There’s consistency in how FDA is applying the rules.” He added that companies will be held responsible for content regardless of the medium. “Limited space is not an excuse for not meeting requirements that have been laid out in guidelines,” Gaydos said.
So then, of course, the question arises: If we already have the FDA information we need, what are we expecting in the anticipated new guidance?
Byrd threw out some ideas of areas the FDA may address, including:
- Fulfilling requirements when space is limited;
- How companies will meet submission requirements; and
- Clear(er) definitions of where companies are accountable in online communications.