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.
Our Position
CHPA fully supports the Rx-to-OTC switch process as a way to benefit consumers with more accessible and affordable self-care solutions.
A comprehensive list of ingredients and dosages transferred from Rx-to-OTC status (or new OTC approvals) by the Food and Drug Administration Since 1975.
CHPA and its member companies have an interest and expertise in label comprehension studies and support FDA's efforts to develop guidance for industry on this important topic.
CHPA comments on issues associated with the public health benefit of certain drugs being available without a prescription, but only after intervention by a pharmacist.
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.
