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.
CHPA released the following statement today by President and CEO, Scott Melville, applauding the introduction of The Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018
CHPA strongly supports the OTC Monograph system as a balanced framework for regulating OTC medicines containing ingredients with a proven history of safe use.
CHPA strongly supports the OTC Monograph System, but we believe that policy reforms could make the system more flexible, responsive, and accommodating to innovation.
Unlike other drugs subject to user fees, nonprescription drugs under the Monograph system are not subject to FDA approval prior to marketing. Many of these ingredients have been marketed for more than 40 years, with a long history of safe use. We must define value differently than industries subject to FDA approval prior to marketing.
CHPA comments on the Agency’s review and action on OTC time and extent applications. This proposed rule would supplement the time and extent application process for OTC drugs by establishing timelines and performance metrics for the Agency’s review of non-sunscreen TEAs.
CHPA issued the following statement following the Food and Drug Administration’s announcement of a public meeting to gather stakeholder input on the potential development of a user fee program for nonprescription monograph drugs.
CHPA spoke today before a Food and Drug Administration Advisory Nonprescription Drugs Advisory Committee, during which the committee discussed data submitted by Galderma Laboratories, L.P. to support the supplemental new drug application for over-the-counter marketing of adapalene gel 0.1%.
CHPA applauds the Energy and Commerce Committee on House passage of the 21st Century Cures initiative. CHPA looks forward to the implementation of these provisions and believes it will help accelerate the discovery, development, and delivery of new treatments and cures for patients
CHPA appreciates the opportunity to provide comments on the FDA’s draft guidance for industry entitled “Best Practices in Developing Proprietary Names for Drugs”. CHPA members hope the Agency will find the suggested revisions in these comments informative as the final version of the guidance is developed.
