Rx-to-OTC switch is the transfer of proven prescription drugs to nonprescription, OTC status. It is a scientifically rigorous and highly regulated process that allows consumers to have OTC access to a growing range of medicines. For a medicine to be granted OTC status, it must have a wide safety margin, be effective, and bear understandable labeling to ensure proper use.
Thanks to Rx-to-OTC switches, families can conveniently buy and use a wider range of medicines and products without having to go to the doctor.
As more prescription allergy medicines have switched to OTC, there has been a clear shift toward these more convenient and affordable options. Allergy sufferers who use OTCs has gone up from 66 percent in 2009 to 75 percent in 2015.
When nicotine replacement therapies went OTC, there was a 150 to 200 percent increase in their purchase and use in the first year after the switch. Increased access enabled tens of thousands of smokers to use these products to help quit smoking. That’s a $2 billion social benefit every year.
CHPA maintains a list of ingredients and dosages transferred from Rx-to-OTC status (or New OTC Approvals) by FDA since 1975.
2022 Rx-to-OTC Switch Symposium
In April 2022 CHPA supported the Reagan-Udall Foundation for the FDA to fund their Snapshot 2022, an Rx-to-OTC switch symposium. The Regan-Udall Foundation is an independent 501(c)(3) organization created by Congress “to advance the mission of the FDA." The half-day symposium featured speakers and participants from Federal agencies, industry, academia, patient groups, provider organizations, and others. Snapshot 2022 examined the current environment for FDA-regulated consumer products and devices, and how healthcare delivery might change in the near future.
We understand that FDA is considering a switch of a second generation antihistamine, from prescription to OTC status, over the objections of the company. CHPA opposes a policy to force switch over the objections of the drug sponsor.
This submission represents CHPA's detailed written comments as follow-up to the June meeting and is intended to complement the Association's oral presentation.
