FDA’s OPDP Warns MannKind for Facebook Post

Regulatory NewsRegulatory News | 16 October 2018 |  By 

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) earlier this month sent a warning letter to MannKind for a Facebook post that makes false or misleading claims about the risks associated with the company’s inhaled insulin, known as Afrezza.
“These violations are especially concerning from a public health perspective because Afrezza is a drug with multiple serious, potentially life-threatening risks, including a BOXED WARNING for the risk of acute bronchospasm in patients with chronic lung disease,” the warning letter says.
Specifically, the promotional Facebook post for Afrezza claims that the drug “will help your body work its best and protect you from health complications” with “no drama,” though FDA says that “may not be the case.”
“By suggesting that there are no risks associated with use of Afrezza, this post is misleading with respect to the drug’s safety,” FDA added. “We note the inclusion of the statement, ‘Please see full Prescribing Information, including boxed WARNING, Medication Guide, and Instructions for Use’ with a link to the PI in the post. However, this statement does not mitigate the misleading impression from the claims in the post.”
OPDP requests that MannKind immediately cease misbranding Afrezza or stop introducing the misbranded drug into interstate commerce.
“In order to clearly identify the violative promotional piece(s) and/or activity and focus on the corrective message(s), OPDP recommends that corrective piece(s) include a description of the violative promotional piece(s) and/or activity, include a summary of the violative message(s), provide information to correct each of the violative message(s), and be free of promotional claims and presentations. To the extent possible, corrective messaging should be distributed using the same media, and generally for the same duration of time and with the same frequency that the violative promotional material was disseminated,” the warning letter says.
Warning Letter
Promotional Material


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