FDA Approves Bladder Control Drug for OTC Use, Highlighting Rx to OTC Switch

On January 25, 2013, the U.S. Food and Drug Administration (“FDA”) announced the approval of the first women’s bladder control product available without a doctor’s prescription. In the past, all bladder control drugs were only available by prescription. This product, called Oxytol for Women, will be made available without a prescription for women aged 18 years and up only. Oxytol will remain available through a prescription only for men. The full story may be accessed

Overactive bladder, a condition where the bladder squeezes too often or without warning, affects up to 33 million Americans annually, and the majority of the afflicted are women.  The active ingredient in the Oxytol is called Oxybutynin, which belongs to a class of drugs known as anticholinergics.  It has the distinction of being the first drug from this class made available for over the counter treatment (“OTC”) for overactive bladder. 

When the original Federal Food, Drug and Cosmetic Act was enacted in 1938, there was no clear distinction between OTC drugs and prescription drugs. It was not until 1951, with the passage of the Durham-Humphrey amendments, that this issue was addressed and specific standards for classification of OTC drugs were created. The Durham-Humphrey amendments required that drugs that are not likely to be used safely without supervision from a doctor be dispensed by prescription only.  These prescription-only drugs were essentially deemed unsafe as they were believed to be habit-forming, toxic, have the pote

ntial for harmful side effects, or are for the treatment of maladies that cannot be diagnosed by a layman. The Durham-Humphrey amendments also provided that all other drugs that do not meet the criteria for unsafe drugs can be sold OTC.

The process of taking a drug from prescription to OTC status is called an “Rx to OTC switch.” This switch can happen in two ways, either by a manufacturer’s submission of additional information about the drug or by an “OTC drug review.” In 1972, OTC drug review began in order to review on an ongoing basis the safety and effectiveness of all drugs that are permitted for non-prescription use.  Through the OTC drug review process, experts in the field then will review the active ingredients to determine if they are indeed safe and effective. The second way a drug is approved for OTC use is through the new drug application process. Under this process, the manufacturer must submit information to the FDA that clearly shows the drug is appropriate for self-administration. Often, the information will include the submittal of studies showing that the product label can be easily read and understood by the consumer without the aid of a healthcare professional. More information about the Rx to OTC switch process may be accessed here.

If you have additional questions with Rx to OTC switch process or the FDA’s regulation of drugs, please contact us at contact@giannamore-law.com.

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