Are pharma social media FDA infractions slipping through the cracks? It took more than three weeks for the FDA to notice Kim Kardashian's regulation-bending Instagram post paid for by anti-morning sickness drug Duchesnay's Diclegis. Similar misleading claims on social media might be going unnoticed altogether, Vox suggests.
While the FDA sent two warning letters and 7 untitled letters to prescription drug makers so far this year, only one--the Kardashian letter--addressed a problem that occurred on social media.
According to the FDA, it reviews between 6,000 and 8,000 pieces of advertising and promotional materials every month. A staff of 32 reviewers, who specialize in different therapeutic areas, sift through the materials, which are required to be submitted by drugmakers at the time of publication. Duchesnay did submit its material, and while the FDA finally flagged it, it was also brought to the agency's attention through the ODPD's Bad Ad program, according to the warning letter.
In 2014, the office sent one warning letter and 9 untitled letters to drugmakers, and only one was for a social media infraction--a Facebook web page for Akrimax Pharmaceutical and IBSA's Tirosint that failed to include risk information. In 2008, another celebrity landed a pharma in trouble when Shire ($SHPG) got an FDA warning letter for an Adderall XR YouTube video that included claims made by home improvement TV show host Ty Pennington; it also omitted risk information.
That doesn't mean the FDA is giving up, of course. It has released four draft guidances to date addressing different topics related to digital and social media promotion, an FDA spokeswoman said via email. When asked about any more forthcoming guidelines, she simply said, "The FDA continues to work on these guidances."
- read the Vox story
- see all 2015 ODPD letters
Special Report: Top 10 pharma companies in social media