February 14, 2020 could be called a red letter day in the world of Rx-to-OTC switch. After a long period of drought, FDA announced that they have approved the Rx-to-OTC switch of three prescription drugs. Please see the announcement here. The three drugs are: Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary relief of arthritis pain; Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%) for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander; and Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%) for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander, for nonprescription use. The last time an Rx-to-OTC happened was in January of 2017 for Xyzal Allergy tablets and solution (here), so, it has been quite a wait for the industry and the American public to see prescription products available over-the-counter in their local pharmacy.
The Rx to OTC switch is one of the best ways to provide cost-effective first-line therapies for many ailments to patients, especially for those with no insurance. Also, for the ones who have insurance but do not have time to go to the doctor, it can assure quick access to medicines, at least as a first line of defense. Then, why don’t we see more drugs being switched from Rx-to-OTC? The reason may be while the benefits to consumers of Rx-to-OTC switches could be significant, they also involve some degree of risk. With a product being available in pharmacies, usage expands, and physician supervision diminishes. This can have many consequences which the sponsors and FDA need to be cognizant of. While approving a Rx-to-OTC switch, the FDA needs to be assured that it is a condition for which consumers can self-diagnose, self-treat, and self-manage, and no health practitioner is needed for the safe and effective use. Additionally, FDA needs assurance that the drug has low potential for misuse and abuse; in other words, the benefits of OTC availability outweigh the risks. These are not easy hurdles to overcome by the sponsor or the FDA. Thus, in some cases, new safety studies could be required to establish the “OTC-ness” of the product (here). Also, based on the safety profile and inherent risk, some medicines may always remain a risk, if available as OTC; certain antibiotics, steroids come to mind. However, at the end of the day, an Rx-to-OTC switch can be beneficial to the patients and the sponsors. It would be good to see more of these happening.
Usually, the Rx-to-OTC switch initiated by a sponsor who holds the NDA to the prescription product can be done based on an NDA or sNDA. However, the 505(b)(2) NDA pathway can be an effective tool for Rx-to-OTC switch if a sponsor, other than the holder of the Rx product, is looking for a new indication. While it sounds easy, this may come with its own challenges and could need additional safety and efficacy studies, if not supported by literature. The 505(b)(2) pathway has gained popularity these days but we see that the path to Rx-to-OTC switch though 505(b)(2) NDAs is greener than the others and in need of more sponsors treading.
In the meantime, we rejoice in the fact that if affected by arthritis pain or itchy eyes, we may now be able to go to our local pharmacy and find a relief right on the shelves.
If you have any questions or are need of services related to regulatory support for Rx-to-OTC switch, please reach out to Lachman Consultants at LCS@Lachmanconsultants.com.