OPDP Enforcement Letters Address Omission of Risk Information

May 23, 2014 – The FDA’s Office of Prescription Drug Promotion (OPDP) has issued just three Untitled Letters to date in 2014, but all of them cite companies for omitting risk information or omitting material facts in various promotional venues, including a printed sales aid, a Facebook page and a sales sheet.

“Clearly, omission of risk information needs to be looked at carefully by companies when they are formulating their promotional strategies,” said Coalition for Healthcare Communication Executive Director John Kamp. “These letters give guidance on what constitutes proper benefit/risk balance, particularly where the drugs have a Boxed Warning.”

The most recent Untitled Letter was sent May 6 to Alvogen Inc. for its DISULFIRAM, a sobriety assistance drug. OPDP states that a sales aid for the product includes claims that make representations about the efficacy of the drug – that it is an alcohol antagonist that aids “in the management of selected chronic alcohol patients who want to remain in a state of enforced sobriety so that supportive and psychotherapeutic treatment may be applied to best advantage” – but fails to communicate any of the risks associated with its use (Disulfiram Letter).

“This omission of risk information is particularly concerning considering that the Disulfiram PI includes a Boxed Warning” about the use of the product, OPDP states in the letter, and that the drug is “associated with a number of serious risks, some of which are potentially fatal.” The letter also cites Alvogen for failing to communicate material information from Disulfiram’s full FDA-approved indication for the management of alcoholism.

On Feb. 24, OPDP issued its first enforcement letter for promotional activities occurring on Facebook to Institut Biochimique SA (IBSA) for a branded Facebook page for TIROSINT (levothyroxine sodium) capsules for oral use (Tirosint Letter). This letter was significant because it was the first enforcement action taken by the FDA for any social media activity since the agency issued its social media guidance on Jan. 13.

The Untitled Letter states that the Facebook page is false or misleading because it “makes representations about the efficacy of Tirosint but fails to communicate any risk information associated with its use and it omits material facts.”  Specifically the Facebook page is cited because the Tirosint PI includes a Boxed Warning, and omitting the most serious and frequently occurring risks on the page “suggests that Tirosint is safer than has been demonstrated.”

Finally, a Jan. 23 Untitled Letter to Mission Pharmaceutical Co. covers a professional sales sheet for TINDAMAX, which OPDP cites for omitting risk information, suggesting that the drug is useful in a broader range of patients or conditions than has been substantiated, making superiority claims, omitting material facts and making an unsubstantiated claim (Tindamax Letter).

It is worth noting that although the company included the following statement – “Please see attached Full Prescribing Information, including Boxed Warning” – as well as the full Boxed Warning on the bottom of the from page of the sales sheet, those inclusions do “not mitigate the omission of the aforementioned risk information.”