The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) has found that Shionogi’s “Patient Co-Pay Assistance Voucher” for Ulesfia (benzyl alcohol) lotion to help treat head lice is false or misleading because it omits important risk information.
The omission of such risk information means that the voucher misbrands Ulesfia within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and makes its distribution violative, FDA said late last week.
"As it states in the letter, we licensed that product to Concordia [Pharmaceuticals] and no longer market or promote that product," Joe Spagnardi, EVP of legal and compliance at Shionogi, told Focus. He said Shionogi was listed on the letter because it's still on the NDA, but that it has been in contact with Concordia and FDA and they are working to resolve the issues raised.
This is OPDP’s second untitled letter of 2016 (the first was for a Pfizer/Hospira YouTube video), and the office makes clear that promotional materials “are misleading if they fail to reveal facts that are material in light of the representations made or with respect to consequences that may result from the use of the drug as recommended or suggested in the materials.”
In the case of the voucher, it makes representations and/or suggestions about the efficacy of Ulesfia such as that it’s “the #1 prescribed branded Rx treatment for head lice” and also that it’s made up of “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.”
FDA notes that the statements “For more information on Ulesfia, please visit www.ulesfialotion.com” and “For more information, please refer to the package insert for full prescribing details or visit www.ulesfialotion.com” are included on the voucher, though they do not mitigate the omission of risk information from the voucher.
“By omitting the risks associated with Ulesfia, the voucher 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,” FDA said.
More specifically, FDA said the voucher omits the following material information that the lotion “does not have ovocidal activity. Additionally, the voucher is misleading because it fails to adequately communicate that Ulesfia is indicated only for patients 6 months of age and older. We acknowledge that the ‘Dear Pharmacists’ section on the bottom of the back page of the voucher contains the statement, ‘Ulesfia . . . is indicated for patient[s] 6 month of age and older’ ... However, this does not mitigate the misleading impression.”
OPDP requests that Shionogi/Concordia immediately cease misbranding Ulesfia and/or cease introducing the misbranded drug into interstate commerce and it requested that the company submit a written response by 13 April 2016, stating whether it intends to comply with this request, listing all promotional materials (with the submission date) for Ulesfia that contain statements such as those described by OPDP, and explaining a plan for discontinuing use of such materials, or for ceasing distribution of Ulesfia.
Untitled Letter from OPDP