OPDP Issues Just Two Enforcement Letters in First Half of 2016

July 22, 2016 – Although 2015 was considered a slow year for enforcement letters issued by the FDA’s Office of Prescription Drug Promotion (OPDP) – just nine total enforcement letters – so far this year OPDP is lagging behind that figure, having issued only one Untitled Letter and one Warning Letter between the beginning of January and the end of June.

“In the absence of new or revised guidance from OPDP on important promotional issues, industry has had to rely in the past on tracking OPDP enforcement letters to determine where the agency was focusing its attention and how it was interpreting the regulations,” said Coalition for Healthcare Communication Executive Director John Kamp. “Without new guidance and with a significant drop in enforcement letters, there are very few indicators left for industry to follow in order to better understand OPDP’s areas of concern regarding potential promotional pitfalls.”

OPDP kicked off 2016 with a Jan. 14 Untitled Letter to Hospira Inc., a Pfizer company, citing a video posted on YouTube that presented 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 (see

The sole Warning Letter issued by OPDP this year, dated March 29, cites Shionogi Inc. for a patient co-pay assistance voucher for Ulesfia®, a benzyl alcohol lotion for topical use that treats head lice infestation. OPDP alleges that the voucher “is false or misleading because it omits important risk information associated with the use of Ulesfia and omits material facts” (Ulesfia Warning Letter)

The Warning Letter states that the voucher for Ulesfia makes several representations about the efficacy of the product (e.g., “Ulesfia is benzyl alcohol 5%, this is a non-neurotoxic formulation, and is not a pesticide and is the #1 prescribed branded Rx product for the treatment of head lice”), but fails to communicate any risk information. Although Shionogi’s voucher includes statements that refer patients to additional information (“For more information on Ulesfia, please visit” and “For more information, please refer to the package insert for full prescribing details”), “these statements do not mitigate the omission of risk information from the voucher,” according to OPDP.

Specifically, OPDP is concerned that a limitation of use from Ulesfia – that it does not have ovocidal activity – has been omitted from the voucher language, and that the voucher fails to stipulate that the product is indicated “only for patients 6 months of age or older.” Further, the company is cited because it failed to submit Form FDA-2253 to the agency.

OPDP asked Shionogi to cease misbranding the product, and submit a written response to the agency which includes a “comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective messages about the issues discussed” because the violations described in the letter “are serious.” OPDP advises that 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.”