Caveat Vendor

Do Proposed #FDA Pharma Twitter Rules Violate the #FirstAmendment?

September 29, 2014

Devon Winkles

How many warnings can one 140-character tweet contain?  Well, under the U.S. Food and Drug Administration’s proposed guidance for pharmaceutical promotion on Twitter and other character-limited platforms such as Google Sitelinks, we soon may find out.  The draft guidance, which was proposed in June, requires drugmakers to include the most serious risks and all contraindications in any tweet containing a product benefit claim.  In addition, the tweet should include a link to a page with a more thorough discussion of the risks and contraindications.

Now, pharmaceutical companies are pushing back.  In letters submitted to the agency, they have argued that not only is FDA’s request impossible to achieve in 140 characters, unclear about the possibility of conveying risk information in images attached to tweets, and contrary to FDA's own tweet history, but it is also in conflict with the First Amendment.

One relevant case involving an FDA speech restriction is U.S. v. Caronia, a Second Circuit case from 2012.  In that decision, the court determined that a sales rep’s truthful off-label promotion of a drug was protected by the First Amendment.  The FDA policy at issue in Caronia, like the new draft policy, imposed speaker-based and content-based restrictions, triggering strict scrutiny.  But even applying intermediate scrutiny the court found that the restriction on truthful, nonmisleading information was unwarranted.  Although recognizing that the government’s asserted interests in drug safety and public health were substantial, FDA’s interpretation of the FDCA did not directly advance those interests and was not narrowly drawn.
Although there are important distinctions here—this policy mandates certain disclosures while the policy at issue in Caronia was a blanket, criminal prohibition on certain speech—the pharma companies make a strong argument that FDA has overreached.  Commenters have suggested that allowing hyperlinked disclosures of risks and contraindications would be a less restrictive way to achieve FDA’s goals.  For instance, the FTC's social media disclosure guidelines suggest use of hyperlinked disclosures and authorize certain disclosures through short, simple hashtags.   Moreover, although not couched as a blanket prohibition, the character limitations on tweets may amount to the same thing, as it may be impossible in many cases to include all the disclosures the FDA guidance would mandate.
On September 29, 2014, FDA reopened the comment period on the draft guidance, in response to a request for additional time and to allow interested persons more time to submit comments.  The new deadline is October 29, 2014.  Comments have already been submitted by groups and companies including the Medical Information Working Group, Pharmaceutical Research and Manufacturers of America (PhRMA), and Eli Lilly and Company.

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