The FDA's hearings on promotion of regulated products online and using social media—the “Super Bowl of Part 15 Hearings,” as Porter Novelli's Peter Pitts dubbed them—got under way yesterday in a near-capacity federal conference hall. More than 800 people had tried to register, said DDMAC director Thomas Abrams, and 69 speakers were slated for 77 scheduled slots running 10-15 minutes each (all the more remarkable considering the conference hall's prohibition on coffee and its lack of wireless).
Thursday's testimony addressed four questions: for what online communications should manufacturers, packagers, or distributors be accountable; how companies can fulfill regulatory requirements in Internet and social media in light of space limitations and real-time tools; what parameters should apply to the posting of corrective information on sites controlled by third parties; and when the use of links is appropriate.
Eli Lilly's Michele Sharp spoke for many manufacturers when she said, “Frankly, to date, Lilly has avoided significant interaction with healthcare professionals and patients about our products in social-media forums—largely because of a lack of clarity in understanding FDA's expectations as to how we could participate and comply with FDA requirements.”
Sharp, who is senior director, US regulatory affairs at Lilly, went on to note the deluge of misinformation online about prescription drugs—a common thread running through the morning's testimony, with industry advocates saying, more or less, “Hey, we're not the bad guys here.”
Execs from J&J and Sanofi-Aventis also gave testimony and offered more specific thoughts on where FDA might draw the line on links, corporate responsibility for content and what might constitute adequate provision of risk information within space-limited formats like Twitter.
Google unveiled a proposed paid search format to replace the “one click rule” that FDA nixed with a flurry of April enforcement letters. Google's Mary Ann Belliveau and Amy Cowan said that since then, companies have been running two adjacent links—one branded, sans indication, and one unbranded. Clickthroughs have plummeted.
“We believe that before, they were more open and transparent,” said Belliveau. “The ads clearly let users know they were for a prescription drug and users were more likely to visit the site and get important risk information.”
Google proposes a format under which an abbreviated statement of major risks, 62 characters long, would run below the main text, alongside a second link that would take the user directly to risk information. For products carrying a boxed warning, this warning tag would read: “Click to see full safety and prescribing information, including boxed warning. More info.”
Just who, if anyone, should be responsible for correcting misinformation was a topic of debate. Anecdotal evidence suggests that many companies are curtailing their involvement in social media for fear of unwittingly running afoul of FDA. Pitts said he knew of a company that ordered employees not to monitor social-media sites so as not to get entangled in hazy adverse-events reporting requirements.
Sixty-four percent of respondents in a WEGO Health survey of online health opinion leaders said that companies should be responsible for policing unauthorized versions of their content—even as 60% conceded that companies cannot reasonably keep up with all mentions of their content.
Diana Zuckerman of the National Research Center for Women and Families, the day's lone pharma critic, argued that because advertising online is so much cheaper than traditional consumer channels, the regulatory burden on marketers should be greater, with warning information granted equal space and placement to benefits.
Should a blog glow inaccurately about a company's product, Zuckerman said, the manufacturer should be required to request a correction, and should bear the burden of proof that the content was not influenced by commercial bias.
Zuckerman also said FDA should be monitoring and correcting misinformation or unbalanced information appearing on sites such as Drugs.com and Wikipedia entries on drugs that tend to place highly in searches. The additional staff required for that function could be funded through a user fee, she suggested. Sponsored links that are text links are much more effective than banner ads.
Many consumer groups could not be at the hearings, she said, because they're too busy with healthcare reform advocacy. Consumers Union will deliver testimony in today's morning session, dealing with questions around adverse-events reporting.
It seems unlikely that much in the way of formal policy change will come of the hearings soon, but many in attendance expressed jubilance that they were being heard. Mark Gaydos, of Sanofi-Aventis and the Social Media Working Group, said: “The fact that we're here at a two-day public hearing is proof of the recognition that industry should be engaged. It's just a question of how."
Matthew Arnold, MM&M's senior editor, will offer his insight and commentary in a roundup following today's testimony, as well.