Recently, the U.S. Food and Drug Administration (“FDA”) released two sets of guidance surrounding how pharmaceutical, medical devices and prescription drug companies should utilize social media platforms, particularly those like Twitter with limited character space, in order to effectively provide information on products to consumers. Specifically, the FDA is concerned with accurately regulating communications of medical devices and prescription drug products in terms of the benefits and risks associated with their usage. However, a #FDAMedia post on Twitter dated June 27th, approving a new product to treat diabetes, “a rapid-acting inhaled insulin”, appears to follow none of the newly conceived guidance.
The new set of media guidance, which goes as far as to provide “Twitter Rules”, reminds the Regulated Entities that “beneficial claims in product promotion should be balanced with risk information (U.S. Department of Health and Human Services Food and Drug Administration, Guidance for Industry Internet/ Social Media Platforms with Character Space Limitations- Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (June 2014).” A thorough examination of the guidance reveals that Regulated Entity’s should qualify with the following criteria (Id., page 5 and 6):
- Be relevant and responsive to the misinformation;
- Be limited and tailed to the misinformation ;
- Be non-promotional in nature, tone and presentation;
- Be accurate;
- Be consistent with the FDA-required labeling for the product;
- Be supported by sufficient evidence, including substantial evidence, when appropriate, for prescription drugs;
- Either be posted in conjunction with the misinformation in the same area of forum (if posted directly to the forum by the firm), or should reference the misinformation and be intended to be posted in conjunction with the misinformation (if provided to the forum operator or author); and
- Disclose that the person providing the corrective information is affiliated with the firm that manufactures, packs, or distributes the product.
The #FDAMedia tweet, which reads “FDA approves Afrezza, a rapid-acting inhaled insult to treat diabetes go.usa.gov/97P9” does not hold any risk information and the generic and chemical name is also not noted. Mark Senak of Fleishman-Hillard’s Washington, D.C. office, who is the blog author of Eye on FDA commented that the, “FDA is not so contrained when it sends out news of its own,” which appears to be an accurate statement concerning this case (“To Tweet or Not to Tweet? Or Even Retweet? FDA, Tweeting and Twitter”).
In the future, it should be expected that the FDA will uphold and abide by its own guidance when posting on social media platforms, or else the expectation that companies will follow suit, is not a realistic one.