PhRMA and other industry organizations took issue with the United States Food and Drug Administration's ("FDA") recent proposed guidance regarding promotion through character-limited communications such as the popular social media site Twitter. FDA issued draft guidance in June 2014, indicating that prescription drug and medical device manufacturers should not use Twitter unless they can include both benefit and risk information within the same tweet (a "tweet" is a maximum 140-character message posted via Twitter). See Internet/Social Media Platforms with Character Space Limitations--Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices, 79 Fed. Reg. 34759 (June 18, 2014).
Under the draft guidance, manufacturers of prescription drugs and medical devices should incorporate both benefit and risk information within the same communication, regardless of space or character constraints. If the manufacturer cannot do so, it "should reconsider using that platform for the intended promotional message." As for risk information, FDA stated that the communication should include, at a minimum, the most serious risks, which would include all risk concepts from a boxed warning, all risks known to be fatal or life threatening, and all contradictions from approved product labeling. Additionally, the communication should contain a direct link to a webpage devoted exclusively to the communication of risk information.
Several industry organizations have filed comments challenging the draft guidance as both unworkable and unconstitutional. The Medical Information Working Group ("MIWG"), for one, has commented that the draft guidance is "tantamount to a ban on the use of space-limited communications," like Twitter. Citing Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011), MIWG argued that the draft guidance violates the First Amendment because it targets a certain class of speakers -- manufacturers -- and a certain type of speech -- truthful statements about medical products. MIWG, PhRMA, and the Bio Industry Organization also filed comments noting that the draft guidance appears to be inconsistent with how FDA itself has utilized character-limited communications like Twitter. For example, PhRMA commented that FDA's own tweets announcing new drug approvals contained only benefit information and a link to the news release that describes risks and additional benefit information. PhRMA further commented that as "a matter of First Amendment law and logic, it cannot be truthful for FDA to use Twitter in this way but misleading for product sponsors to do the same."
The comment period closed on September 16, 2014. It is well worth watching how FDA will revise the final guidance based on these responses from the pharmaceutical industry.