In an unusual 12-0 vote, an FDA advisory panel recommended that the acne treatment adapalene gel 0.1% be switched to Over-the-Counter (OTC) use. If the FDA concurs, this will be another FDA approved product to join a number of OTC monograph products in the OTC market to treat acne.
This came as a bit of a surprise to me as the retinoid products have some side effects that occur (according to the labeling) in 10-40% of patients, but apparently the panel did not think that the types of adverse events were serious enough to preclude OTC availability and self-treatment.
It appears as a whole, the Agency is more prone to entertain Rx to OTC switches than it might have been years ago. I blogged about the OTC switch for Nasacort AQ (triamcinolone acetonide) nasally inhaled glucocorticoid (here) and addressed my surprise about the FDA action to permit a steroid-based OTC product for nasal inhalation.
If FDA eventually approves the adapalene OTC switch, it may spell problems for other approved generic makers of the adapalene gel 0.1% product. As we reported here, there is an unresolved issue that FDA may now have to address that relates to the same products being marketed as both Rx and OTC at the same time, unless there is a leave-behind indication for Rx use. Given the FDA advisory panel’s recommendation that the product be used in patients 12 years of age and older, as well as the current labeling that states: “Safety and effectiveness in pediatric patients below the age of 12 have not been established,” it does not seem that there can be too many differences that might permit the simultaneous marketing of both versions of this drug.
In addition, if the NDA holder had to perform clinical studies that were essential for the approval for the OTC switch, then they may be entitled to 3 years of Hatch-Waxman exclusivity, which could pose a problem for other approved generic manufacturers that may also want to make the OTC change in labeling. If exclusivity is awarded, then the question of whether FDA will drag its feet relative to the Rx/OTC simultaneous marketing dilemma becomes an issue for the NDA holder of the switched application, as the generic may still be available as an Rx product for the 3-year exclusivity period. Perhaps insurance companies will stop paying for the Rx version once the OTC product is available (which would obviously be a problem for the generics). If, however, there is no eligibility for exclusivity or patent protection for the OTC product’s use, then generics will simply need to revise their label, and supplement their ANDA applications for the labeling change if the innovator’s adapalene product is the same formulation it currently markets. If the product has changed, then generics may be in for a longer process to obtain OTC marketing authorization.
You just never know when these switches will raise some regulatory issue that causes a breakout on the face of FDA, the innovator, or a generic manufacturer, but at least they will have an OTC product to treat the condition.
