PhRMA and MIWG Challenge the Constitutionality of the FDA’s Twitter Guidance

By Vaughn Bentley, DePaul University College of Law-

The Food and Drug Administration (“FDA”) recently released a draft guidance for pharmaceutical companies looking to advertise on Twitter, Guidance for Industry Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices. The guidance makes it illegal to advertise only positive benefits of drugs on social media without having a negative effect in the same posting. Since the release of the guidance in the June of 2014, the pharmaceutical companies have responded with a chorus of objections and outcry. One of the more interesting objections the pharmaceutical industry has raised is that the draft guidance is unconstitutional.

Pharmaceutical Research and Manufacturers of America (“PhRMA”), a trade group that represents the country’s leading biopharmaceutical researchers and biotechnology companies, is one of the groups challenging the constitutionality of the draft guidance. According to PhRMA, the FDA is not applying the same standard to manufacturers as it would apply to any federal agency. PhRMA illustrated its argument by pointing to a tweet posted by the FDA, regarding a new diabetes drug, that would not have passed muster under the draft guidance. The tweet in question simply stated that the FDA had approved the new drug with a link to the news release about the approval. PhRMA noted that 60 people had retweeted the news. The draft guidance suggests manufacturers could be punished for retweeting the news. The trade group went on to comment the FDA could not punish the retweeters for simply repeating what the FDA had said. PhRMA suggests this violates First Amendment logic and law by claiming the FDA using Twitter in a seemingly advertising way is truthful, while a manufacturer doing substantially the same would be misleading.

The Medical Information Working Group (“MIWG”), a coalition focused on pharmaceutical promotion, is challenging the draft guidance on separate, but still related First Amendment grounds. MIWG argues that the guidance is “tantamount to a ban on the use of space-limited communications.” MIWG draws support from Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011). In IMS Health Inc., a Vermont statute restricted the sale, disclosure, or use of pharmacy records revealing the prescribing practices of individual doctors. This included the marketing of pharmaceutical products to individual physicians, which is made easier if the manufacturer knows the physician’s prescription practices. The Supreme Court held speech in aid of pharmaceutical marketing is a form of expression protected by the First Amendment. MIWG draws comparisons between the marketing restriction held unconstitutional in IMS Health Inc. and the marketing restricted under the draft guidance. The MIWG claims the draft guidance is unconstitutional because it targets manufacturers, a specific class of speakers, and truthful statements about medical products, a specific type of speech.

Others are claiming that the draft guidance amounts to the FDA criminalizing the use of Twitter by pharmaceutical companies. The guidelines state that if a manufacturer cannot fit the required benefits and risks into the character limits imposed by Twitter, the manufacturer should reconsider using Twitter or other social media platforms. While characterizing this policy as ‘criminalizing’ may be extreme, at minimum, the FDA’s guidance has the potential to discouraging social media use.

Nevertheless, the guidelines are still in a draft form and the FDA may still decide to alter the guidance to operate closer to “dot com disclosures.” Under a FDA guidance from last year, pharmaceutical manufacturers can make a disclosure of the risks clear and conspicuously on the page linked to in a space-constrained ad. The FDA could apply the same logic to tweets from the manufacturers.

It is unclear how the FDA will proceed in light of these constitutional challenges. Some commentators have speculated if the FDA will continue to push forward with the draft guidance in light of these recent objections. For the time being, the comment period has been expanded until October 29. Regardless, it will be interesting to see how the FDA, in the coming months, adjusts its policies in light of twenty-first century media.
Vaughn Bentley is a student at DePaul University College of Law, and is expected to graduate in May of 2016. Vaughn attended State University of New York, College at Oswego and is the DePaul Health Law Institute Vice Chair of Marketing, a writer on the Journal of Health Care Law and the DePaul Health Law Institute E-Pulse. Vaughn is a Johnson Law Scholarship recipient and was on the Dean’s List in the Fall of 2013 and the Spring of 2014.