BIO, PhRMA seek FDA reassurance over scope of Twitter guidance

The window for commenting on the FDA's draft guidance on pharma's use of Twitter ($TWTR) and other social media slammed shut last week, leaving the agency with a stack of feedback to consider. Many of the respondents are unhappy with the draft, which was called unconstitutional and overbroad.

BIO, PhRMA and 11 other organizations submitted feedback on the guidance. Many picked up on similar themes, with BIO and PhRMA both picking up on the extent to which the guidance applies to scientific exchanges. BIO presents a hypothetical situation in which incorrect information about the post hoc analysis of a clinical trial or the off-label use of an FDA-approved product is discussed on social media. BIO thinks the guidance should permit the correction of such misinformation.

"Because such legitimate scientific exchange would not otherwise constitute advertising or labeling, BIO believes that such interchanges fall outside the scope of the guidance but are permissible under the already applicable principles governing scientific exchange," the biotech trade group wrote. Both BIO and PhRMA have asked the FDA for reassurance that the guidance won't stop the exchange of scientific ideas on social media.

How and when companies can correct misinformation comes up again and again in the feedback. BIO makes the argument that "the provision by a manufacturer of truthful and not misleading information" about its own products is protected under the First Amendment.

- access the feedback
- read The Hill's take

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