FDA chastises Shionogi for misleading copay voucher
- Shionogi's copay assistance voucher program for Ulesfia (benzyl alcohol), a head lice treatment, omits important risk information and is misleading, the FDA has found.
- In a warning letter from the FDA's Office of Prescription Drug Promotion (OPDP), the agency tells Shionogi that the voucher misbrands Ulesfia and "is false or misleading because it omits important risk information associated with the use of Ulesfia and omits material facts."
- "These violations are concerning from a public health perspective because they create a misleading impression about the safety and effectiveness of Ulesfia," the warning letter states. Specifically, the voucher failed to reveal that the lotion does not have ovicidal activity and is only indicated for children six months and older.
This is the second untitled letter that OPDP has sent out this year. Promotional materials are deemed misleading if they fail to reveal the risk associated with a specific product.
The voucher contains two statements that touch on risk: One statement directs users to the website URL for Ulesfia, while the other directs users to see full prescribing details. The OPDP found that neither is sufficient to communicate the risks associated with Ulesfia.
The voucher is even more unbalanced because of the promotional copy, which refers to Ulesfia as "the #1 prescribed branded Rx treatment for head lice" and also references the "non-neurotoxic" formulation of Ulesfia -- benzyl alcohol 5%. Both were suggestive of efficacy without communicating risks, the FDA said.
OPDP has requested the Shionogi/Concordia immediately cease misbranding Ulesfia. A written response from the company is due by April 13.
- Regulatory Affairs Professional Society OPDP Untitled Letter Takes Issue With Shionogi's Copay Assistance Voucher