Are the Food and Drug Administration’s proposed social media regulations unconstitutional?

According to comments filed by several pharmaceutical companies and industry groups, the draft guidance issued by the agency in June 2014 presents both practical hurdles as well as constitutional concerns about freedom of speech. In the guidance, consisting of two separate documents, the FDA emphasized that risk information must be communicated to consumers, no matter the space constraints or other limitations of social media.

“Risk information should be comparable in content and prominence to benefit claims within the product promotion,” the agency wrote. “Achieving a balanced presentation requires firms to carefully consider the desired benefit claims and risk profiles for their products when choosing a promotional platform.”

But in comments filed in response to the draft, groups such as the Pharmaceutical Research and Manufacturers of America and the Medical Information Working Group (“MIWG”), as well as several leading pharmaceutical companies, said the guidance would have a chilling effect on their attempts to convey product information to consumers via social media.

The FDA’s guidance is “tantamount to a ban on the use of space-limited communications,” the MIWG wrote, because of the abundance of information required by the agency to be included in a statement (brand name, nonproprietary name, usage, risks, and a link to the full prescribing information) with limited space. The guidance makes it “a practical impossibility for manufacturers to use Twitter and similar media to communicate the availability of their products,” the group said.

Another practical obstacle noted by commenters is the FDA’s requirement that sitelinks be included in ads to more fully disclose risks. One problem: search engines such as Google have a policy that sitelinks may not always appear. “Thus, under FDA’s proposed approach, manufacturers can use Google’s sponsored links only at risk, and the draft operates as a ban with respect to this channel as well,” the MIWG wrote. Several commenters noted that the FDA has not been following its own guidance. The agency tweeted on June 27 that a new diabetes drug, Afrezza, had been approved. About 60 entities retweeted the comment. Although the guidance advised drug manufacturers to list all serious risks and contraindications, the FDA did not mention a single risk in its tweet, let alone that Afrezza carries a black box warning, the PhRMA noted in its comments.

“Needless to say, FDA did not – and could not – punish the retweeters for merely repeating what FDA said about Afrezza,” the group wrote. “And yet the draft guidance suggests that companies that research, develop and deliver innovative medicines – and these companies alone – could be punished for doing just that.”

To read the comment from the Medical Information Working Group, click here.

To read the comment from the Pharmaceutical Research and Manufacturers of America, click here.

Why it matters: After waiting years for some form of social media guidance from the agency, the pharmaceutical industry was overwhelmingly negative about the FDA’s efforts. Perhaps in hopes for more positive feedback, the agency reopened the comment period for the two documents, allowing an additional 30 days for interested parties to comment starting September 29.