On October 5, 2018, the Office of Prescription Drug Promotion (OPDP) of the United States Food and Drug Administration (FDA) issued a Warning Letter to Michael Castagna, the Chief Executive Officer of MannKind Corporation. The Warning Letter took issue with the company’s recent Facebook post for AFREZZA® inhalation powder, which was determined to make “false or misleading claims and/or representations about the risks associated with Afrezza by suggesting that there are no safety concerns associated with the use of the drug.” The post, therefore, is found to misbrand the prescription within the Federal Food, Drug and Cosmetic Act (FD&C Act).
OPDP felt as though the post was false or misleading when it came to risks or benefits because it “suggests that there are no risks associated with the use of the drug” and that the post claims that “’Afrezza Inhalation Powder’ ‘will help your body work its best and protect you from health complications’ with ‘no drama,’ when this may not be the case.” OPDP notes that Afrezza is actually associated with some serious, and possibly even life-threatening risks, including acute bronchospasm in patients with chronic lung disease.
While OPDP did note that the acute bronchospasm risk was included with Afrezza’s indication in text format in a separate pop-up box that is visible when hovering the cursor over the thumbnail of the Afrezza logo in the top left corner of the post, but presenting the risk information that way “does not mitigate the misleading impression from the claims in the post. Moreover, neither the post nor the pop-up box include information regarding two of the conditions for which Afrezza is contraindicated” (hypoglycemia and in patients with hypersensitivity to regular human insulin or any Afrezza excipients), not does it include any other warnings or precautions associated with the drug.
As a result, OPDP requested that MannKind stop misbranding Afrezza and/or stop introducing the misbranded drug into interstate commerce. OPDP requested a response from MannKind by October 19, 2018, including whether the company is gong to comply with the request, a list of all promotional materials for the drug that contain statements such as those described in the letter, and an explanation of the plan to discontinue the marketing materials or stopping Afrezza distribution. OPDP also requested that “[b]ecause the violations described above are serious,” that the company’s response include a “comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed in this letter to the audience(s) that received the violative promotional materials.” Not only does the original post seem to be taken down, but at the time of writing this article, the entire Afrezza Inhalation Powder page was unable to be found on Facebook.
In addition to this being one of the few warning letters issued because of a social media post, it seems to be the first Warning Letter that specifically refers to the OPDP Bad Ad Program, launched in 2010.
The lesson pharmaceutical companies can take away from this Warning Letter is that even though MannKind had put a link to “full Prescribing Information, including boxed WARNING, Medication Guide, and Instructions for Use” at the very top of the Facebook post, it was still deemed to be noncompliant. One may infer from that, then, that the OPDP expects companies to be more upfront about warnings and risks associated with prescriptions, not “hide” them behind an easily-clickable URL.