Jan. 25, 2016 – The Office of Prescription Drug Promotion (OPDP) kicked off 2016 with a Jan. 14 Untitled Letter to Hospira Inc., a Pfizer company, citing a video posted on YouTube that presents information about what to expect from Hospira’s Precedex™. OPDP states in the letter that the video “is false or misleading because it omits risks and material facts associated with Precedex.” OPDP states that it found the video as part of its “routine monitoring and surveillance program,” which clearly indicates that OPDP is paying attention to online marketing channels.

Precedex is indicated for sedation of initially intubated and mechanically ventilated patients in an intensive care setting.  Specific charges in the enforcement letter include:

• Omission of risk information. The letter alleges that the YouTube video contains numerous efficacy claims for Precedex, “but fails to include risk information associated with the use of the drug.” The video also alludes to “arousability” as a benefit, rather than a risk, of Precedex. “The video fails to provide material information about the consequences that may result from the use of the drug and creates a misleading impression about the drug’s safety,” according to OPDP.
• Omission of material fact. OPDP claims that the YouTube video makes representations about the use of Precedex but fails to communicate material information regarding the FDA-approved indication for the product.
• Failure to submit under Form FDA-2253. The OPDP also cites the company for not submitting a copy of the video to OPDP under Form FDA-2253.

Although OPDP started off 2016 with an early enforcement letter, enforcement letters in 2015 dropped off after August. In the second half of 2015 (June-December 2015), OPDP issued two Warning Letters and one Untitled Letter, bringing the total for 2015 to nine enforcement letters, two of which were Warning Letters. The three letters from the second half of 2015 are summarized below. [Click on the link for a summary of the enforcement letters for first six months of 2015.]

ASCEND Therapeutics US, LLC (June 23, 2015)

In this Untitled Letter to ASCEND Therapeutics, OPDP finds a professional EstroGel® Zazzle Card to be false and misleading because it omits important risk information associated with the use of EstroGel, misbranding the product and making its distribution violative. The letter states that the Zazzle card is misleading because, for example, it “fails to include information from the boxed warning that EstroGel, alone or with progestin, should not be used for the prevention of cardiovascular disease or dementia” and fails to disclose material information about the specific risks related to cancers and cardiovascular disorders. Further, OPDP cites the company for failing to include contraindications in the materials. Although the Zazzle card refers readers to www.estrogel.com for additional information and to see the full prescribing information and boxed warning, this “does not mitigate the omission of these important risks.”

ECR Pharmaceuticals (July 27, 2015)

OPDP sent a Warning Letter to ECR Pharmaceuticals, a wholly owned subsidiary of Valeant Pharmaceuticals International, citing a professional sales aid for TussiCaps® Extended-release Capsules CII because it omits risk information, inadequately communicates the full indication for the drug, and presents unsubstantiated claims for TussiCaps. Although the sales aid, which includes no risk information about the product, states that it is to remain in the possession of the sales representative, this phrase does not mitigate the omission of risk information, according to OPDP. Also, the sales aid does not stipulate that the product is to be used only by adults and children six years of age and older, as spelled out in the PI, and inclusion of an image of a young child on the sales aid constitutes “a misleading impression.” OPDP further states that claims of a preference for capsules over liquid are unsubstantiated. “These violations are concerning from a public health perspective because they suggest that TussiCaps, a drug associated with a number of serious and potentially fatal risks, is safer than has been demonstrated.”

Duchesnay Inc. (Aug. 7, 2015)

A Warning Letter from OPDP to Duchesnay Inc. cited a social media post by Kim Kardashian for DICLEGIS, which is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management, because “it presents efficacy information but fails to communicate any risk information with its use and it omits material facts.” OPDP had previously sent an Untitled Letter to Duchesnay in November 2013 for similar violations. The Aug. 7, 2015, Warning Letter cites a Kardashian post on Instagram because it “entirely omits all risk information,” and fails to provide material information about Diclegis’ full approved indication, including important limitations of use. “Specifically, it fails to convey that Diclegis has not been studied in women with hyperemesis gravidarum,” the letter states. Statements that refer readers to the safety information about the product with Web links do not mitigate these omissions, according to OPDP. The OPDP requested that corrective messaging 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.”