Well, it appears the FDA do have teeth after all, well much bigger fangs than their British and Canadian counterparts the MHRA and Health Canada.
The American medicine regulator has fired off a warning letter to Duchesnay, the Canadian based pharmaceutical company, who recently hired the services of socialite, and model. Kim Kardashian. It's unknown how much Kardashian was paid by Duchesnay to promote their morning sickness pill, Diclegis to her 47 million social media followers.
The FDA, in a letter to Duchesnay's Executive Vice President, Eric Gervais, have come down hard and highlighted a number of violations.
- The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts.
- The social media post misbrands DICLEGIS within the meaning o the Federal Food, Drug, and Cosmetic Act (FD&C Act) and makes its distribution violative.
- These violations are concerning from a public health perspective because they suggest that DICLEGIS is safer than has been demonstrated.
The warning letter goes on to say that The Office of Prescription Drug Promotion (OPDP) expressed concerns regarding violative promotional activities for DICLEGIS as recently as November 2013.
On November 12, 2013, OPDP sent Duchesnay an Untitled Letter regarding a letter announcing the approval of DICLEGIS. The letter cited in the Untitled Letter was false or misleading because, among other concerns, it omitted all risk information and omitted material facts regarding DICLEGIS’ important limitation of use. OPDP is concerned that Duchesnay is continuing to promote DICLEGIS in a violative manner.The OPDP have now requested, according to the warning letter, that Duchesnay " immediately cease misbranding DICLEGIS and/or cease introducing the misbranded drug into interstate commerce." They have also requested that Duchesnay, " submit a written response to this letter on or before August 21, 2015, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for DICLEGIS that contain presentations such as those described above, and explaining your plan for discontinuing use of such materials, or, in the alternative, for ceasing distribution of DICLEGIS. "
It only seems like yesterday that Duchesnay's Market Analyst, Danny Martel. wrote me on Twitter and told me to "educate myself" regarding Duchesnay's Diclegis. This coming after my first post about the Kardashian controversy (links below)
Good to see the FDA showing their teeth and it will be interesting to see the grovelling letter of apology Duchesnay now make to the FDA.
The FDA Warning letter to Duchesnay can be downloaded here.
Bob Fiddaman
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