In this post, I summarize some of the comments submitted by the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents the country‘s leading pharmaceutical research and biotechnology companies.
Novartis may be "cheeky" in suggesting that the FDA delete this and delete that, but PhRMA takes a decidedly litigious stance and suggests that the FDA is overstepping its authority under the Federal Food, Drug and Cosmetic Act (FDCA) and the First Amendment.
Instead of asking the FDA to clarify what it means by drug firms having "influence" over third-party sites -- which is what most other commenters asked -- PhRMA said that holding a biopharmaceutical manufacturer accountable for content written by third-parties on third-party web sites if the company merely "influences" the third-party is
"overbroad and is inconsistent with the FDCA. Put simply," said PhRMA, "third-party statements not caused or controlled by a manufacturer do not fall within the statutory or regulatory scope of FDA‘s authority to regulate promotional labeling or advertising. Second, the Draft Guidance erroneously assumes that all manufacturer statements about prescription medicines on social media constitute promotional labeling or advertising. This expansive interpretation of labeling and advertising adopted in the Draft Guidance could chill truthful and non-misleading communication protected by the First Amendment. Thus, it is critical that FDA address these fundamental issues in the Final Guidance."And that's the end of that! But PhRMA had plenty more to say about the Draft Guidance.