Commentary

Pharma Pushes Back on FDA Guidelines

After just a few years of delay, the FDA issued draft guidelines for pharmaceutical marketers using social media back in June, but -- surprise, surprise -- pharmaceutical companies aren’t happy with the proposed rules. This week The Hill reported that pharma groups are complaining the FDA’s suggestions would have a “chilling” effect on their social media interactions with consumers.

As noted in a previous post, the FDA’s second draft guideline dealt with correcting misinformation on third-party sites (for example Wikipedia or discussion forums). The FDA acknowledged that given site constraints it may not be possible to make all the usual disclosures about a product while engaging with the site. In these cases, if the firm is not responsible for the original statement it is not required to make the full product disclosures in its statement, provided all the information in its own statement it provides is correct; the company should also identify itself as the source of the new information, and should not try to use the correction as an opportunity to promote the drug.

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According to The Hill, the Pharmaceutical Research and Manufacturers of America voiced a couple concerns about this guideline, including “the assumption that biopharmaceutical developers can be held responsible for content written by third-parties and on third-party websites if they have influence on the third party.” Here the guidelines refer, for example, to an affiliated company that posts information about a drug; in this situation, if the affiliated company gets it wrong, is the pharmaceutical company legally liable for their error because they have “influence” on the affiliated company?

In the same vein a separate response from the Biotechnology Industry Organization Comments objected to a “broader interpretation of the concept of 'influence or control’” in this area, while the Medical Information Working Group also called this requirement “impermissibly broad” given the “unpredictable” nature of user generated content. Overall PhRMA asked the FDA to “hold manufacturers accountable for online and social media content only to the extend the content was developed or posted by or on behalf of the manufacturer.”

Furthermore, PhRMA also noted that the FDA had failed “to provide guidance about what kinds of statements correcting misinformation on social media qualify as labeling or advertising.” For example (and I’m just making this scenario up) if a blogger mistakenly said a drug is for erectile dysfunction when it’s really for high blood pressure, and the drug maker tries to correct the misinformation with a comment on the blog saying “Drug X is used to treat high blood pressure,” is that considered an attempt to “promote” the drug? Logically any discussion of a drug that mentions its intended purpose might be considered promotional in nature for regulatory purposes -- but such an interpretation could serve to shut down pretty much any discussion at all.

PhRMA also suggested that the FDA “Detail how companies could correct false or misleading third-party information regarding a products' off-label uses,” and “Permit companies to link to any FDA-compliant site when correcting misinformation.”

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