FDA deems Shionogi's head lice copay coupon false, misleading

The front of Shionogi's Ulesfia copay voucher.--Courtesy of the FDA

Things are getting hairy for New Jersey-based pharma Shionogi and its head lice treatment Ulesfia. The FDA is chastising the company for putting out a copay coupon that talks up the lotion's benefits without warning patients about its risks.

Shionogi's voucher is "false or misleading" because it leaves out important risk information associated with the lotion and "omits material facts," the FDA's Office of Prescription Drug Promotion (OPDP) said in a warning letter to the company.

The company's copay coupons claim that Ulesfia is "the #1 prescribed branded Rx treatment for head lice" and that it contains benzyl alcohol 5%, which is "a non-neurotoxic formulation, and is not a pesticide." But Shionogi does not spell out the products' limitations, including the fact that it does not kill lice eggs, also known as nits, regulators said.

And the company did not adequately warn patients that Ulesfia is only approved for certain patients. In a "Dear Pharmacists" section at the bottom of the back page of the voucher, Shionogi said that the lotion is only intended for individuals older than 6 months. But that information "does not mitigate the misleading impression" given to consumers, the FDA said in its letter.

The lesson for pharma marketers? Don't neglect the risk-benefit language on copay flyers. They may be coupons, but the FDA thinks they're promos, too. And don't relegate key details to the fine print.

Now, the agency wants the company to clean up its act. The OPDP is ordering Shionogi to stop misbranding Ulesfia "immediately" and to submit a plan by April 13 on how it will discontinue the coupons.

Regulators are also asking the company to issue a corrected copay voucher that is "free of promotional claims and presentations," the FDA said in its letter. "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," the agency said.

Shionogi is not taking all the blame, though. The company is "not responsible for the marketing and promotional aspects" of Ulesfia because it gave Concordia Pharmaceuticals the license for marketing activities for the drug in 2013, Shionogi's Executive VP of Legal and Compliance Joseph Spagnardi told FiercePharmaMarketing

But Shionogi is still the NDA holder for the drug, so the agency was required to send it a note, Spagnardi said. The company takes the latest FDA action "very seriously" and plans to work with Concordia and the agency to resolve the issues, he said. 

- read the FDA warning letter (PDF)
- here's Shionogi's copay voucher (PDF)