A few months after sending an untitled letter to ARS Pharmaceuticals, taking issue with certain aspects of a TV commercial about its epinephrine nasal spray, the FDA is reiterating its concerns about Neffy’s advertising language.
A newly posted untitled letter (PDF) from the regulator’s Office of Prescription Drug Promotion (OPDP) dated Jan. 23 outlines its determination that a TV ad for Neffy is “false or misleading.” It follows another (PDF) that arrived in the Sept. 9 deluge and contained similar complaints.
For one, the new letter pinpointed several moments where the ad dismisses needles and “needle fear,” including in its jingle that spoofs on the 1969 song “Na Na Hey Hey Kiss Him Goodbye” to bid needles farewell.
According to the FDA, those phrases suggest not only that Neffy can eliminate needle-phobia but also that it completely frees people from needing to use injectable treatments to treat allergic reactions in emergency situations—“when this has not been demonstrated,” the agency wrote.
Though the letter acknowledged that the commercial does now include onscreen text noting that “if additional emergency medical help is needed to treat your allergic reaction, treatments may include other injectable products,” the OPDP said that statement fails to fully mitigate the “no needles, goodbye” wording of the jingle.
The FDA also took issue with the ad’s narration, which used phrases like “Hello, getaways. Goodbye, stressful days” and “Hello, celebration. Goodbye, hesitation,” and said it improperly implies that people no longer need to be vigilant about allergens if they have Neffy on hand.
“Patients with severe allergies still must consider their particular situation in order to take appropriate precautionary measures to avoid allergen exposure and a potentially life-threatening anaphylactic reaction, regardless of access to Neffy treatment,” the OPDP wrote.
Finally, the regulator called out imagery in the commercial showing people storing Neffy in carrying cases and bags without its blister packaging, despite product labeling saying it should stay in the blister pack until needed.
As with its previous untitled letter to the company, the FDA gave ARS 15 working days to respond and address its concerns.
In a statement sent to Fierce Pharma Marketing, ARS countered the FDA’s bugbears.
“We are working with the Office of Prescription Drug Promotion (OPDP) about the points raised in their most recent letter, which we feel were already addressed,” the company said. “At the same time, we disagree with the assertion that the commercial in question was misleading, particularly with respect to the well-documented issue of needle hesitancy and the way Neffy is packaged and carried.”
The Neffy carrying case shown in the commercial “was previously reviewed and approved by the FDA in writing prior to launch as a promotional item for patient distribution,” the company said, adding that it’s expecting approval from the agency in about two months for a supplement application currently under review that would “include the carry case in the labeling and for co-packaging with each prescription of Neffy.”
As for the claims about needle fear, that issue was “central to the FDA’s decision to grant Fast-Track Designation and ultimately approve Neffy in 2024,” the company claimed.
Furthermore, it said, the FDA’s objection to the “goodbye, needles” wording “appears to be attributing an adverse situation with injection products that is attributed to Neffy,” the statement continued, reiterating its inclusion of the disclaimer that injection products may still be required for follow-up care.
Finally, after contending with all of the FDA’s claims, ARS noted that it has already been airing a new TV commercial since mid-January, “that aligns our current business priorities, and removes the ‘Goodbye needle’ statement.”
“As a result, the concerns outlined in the letter from OPDP do not reflect our current broadcast advertising,” it concluded.