FDA is reopening the comment period for its two controversial draft social media guidances. The decision comes in response to requests for additional time to allow interested parties to submit comments.
As stated in the Federal Register, starting on September 29, 2014, the public will have an additional thirty (30) days to provide comments on the following guidance documents: (1) Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (available here); and (2) Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (available here).
We wrote an extensive analysis on both guidance documents: the character space limit guidance, and the third-party misinformation guidance.
If you are interested in commenting on these guidance documents, submit electronic comments here for the Internet/Social Media Platforms with Character Space Limitations guidance document or here for the Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices guidance document.
Thus far, feedback from industry and user groups has been critical, especially comments from the Washington Legal Foundation and Pharmaceutical Research and Manufacturers of America (PhRMA).
In its comment, the Washington Legal Foundation urged the agency to rescind the draft character limit guidance, arguing it imposes severe restrictions on the right of drug and medical device manufacturers to use Twitter and other social media. The Foundation argues that FDA’s speech restrictions violate the manufacturers’ First Amendment rights and that less restrictive methods could be used to reach the FDA’s goals as opposed to total speech ban.
They wrote: “the gist of the draft guidance is that manufacturers should rarely, if ever, attempt to use Internet/social media platforms with character space limitations because those limitations do not provide manufacturers with sufficient space to include all the risk and benefit information that FDA asserts is a necessary part of any such communications.
“The de facto prohibition on use of such Internet/social media platforms is inconsistent with FDA’s statutory mandate and raises serious First Amendment concerns regarding the rights of manufacturers to speak truthfully on important healthcare issues.”
Additionally, the Pharmaceutical Research and Manufacturers of America criticized FDA for its inconsistency:
“PhRMA and its member companies would like to highlight that FDA’s Draft Guidance is inconsistent with the agency’s own responsible communications about medicines using Internet and social media platforms with character space limitations. Specifically, FDA now uses character-limited platforms to announce information about drugs and does it in a responsible, truthful way, including providing safety overviews after Twitter links. Yet FDA proposes to restrict manufacturers from using the same social media tools that FDA uses. FDA’s own actions – including the use of links to present risk information and general descriptions of the benefits of drugs – provide reasonable standards for appropriate use of these media … it cannot be truthful and non-misleading for FDA to use character-space-limited platforms in one way, but misleading for biopharmaceutical companies to do the same.”
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As we noted in our coverage of the guidances when they came out, FDA’s document on correcting third party misinformation provided some specific answers to important industry interactions within social media. However, the “Twitter guidance” added little to the discussion. In most cases, 140-characters is an impossibly small amount of space to cover what FDA requires for many drugs. We will be interested in following FDA’s response to feedback in the coming months.