After years of waiting, drugmakers received the first slice of FDA social media guidance in January, but having had a chance to review the draft, some are unhappy. In recent days FDA's mailbag has filled up with letters on First Amendment protections, "jurisdictional creep" and other topics from the likes of Pfizer ($PFE) and PhRMA.
Regulatory Focus spotted the publication of a batch of comments on the draft guidance and picked out the main concerns bothering PhRMA, BIO and some of the companies they represent. PhRMA welcomed the guidance, before going on to list two fundamental problems it has with the current draft. PhRMA fears that FDA assumes companies are responsible for content written by third parties on third-party sites if the business "influences" the author. Many of the other letters to FDA also raise concerns about how broadly the regulator interprets the word "influences."
PhRMA's second point relates to whether all company posts about prescription drugs on social media are classed as advertising. The trade group thinks the draft makes this assumption, but warns that to do so "could chill truthful and non-misleading communication protected by the First Amendment." BIO and Pfizer also picked holes in this aspect of the draft, with the New York-based drugmaker warning it represents "jurisdictional creep" by the FDA.
The comment period for the draft closed this week, leaving FDA with 18 letters from Eli Lilly ($LLY), Novartis ($NVS), Shire ($SHPG) and others to work through before writing up its final guidance.
- read the Regulatory Focus article
- here are the comments