Over-the-Counter

By: Jordan Mummau, CIS Compliance Associate
jordanmummau@cis-partners.com

To be honest, it took me until I was about 16 to figure out that over-the-counter drugs in any particular pharmacy were never really behind a counter to begin with. Back then, I assumed that a pharmacist had to hand you the product over a physical counter to be qualified as an over-the-counter drug (which is ironic because this would more closely describe the process for obtaining prescription drugs). Is this common? Unfortunately, I doubt it; I would assume most people understand the difference between the term “over-the-counter” and the act of physically passing something over a counter. At 16, I also seemed to share the more mainstream problem of understanding the difference between 10:00pm and 1:00am. I was told to be home at 10:00pm, which I naturally assumed was equivalent to 1:00am. But I digress…

I am pleased to announce that I have come a long way since then. I am older, debatably wiser, and more prone to balding and accidental falls. I am also able to wrap my head around the figurative over-the-counter process, having acquired an understanding of the FDA approval process drugs must go through in order to make it to pharmacy shelves.

The incentives of manufacturing over the counter (OTC) products versus prescription drugs are obvious. Manufacturers are able to market their products directly to consumers (DTC advertising), which allows for increased sales and profits[1]. This also alleviates extra spending on sales reps to visit and educate physicians on prescribing their medications, the side effects of these drugs, and ways to promote the drugs, all things pharmaceutical companies often have to do to foster awareness of their prescription drugs[2]. DTC advertising allows companies to lower the retail prices on their OTC drugs, and provides access to a larger market than physicians alone would be able to expose them to.

However, in order for a drug to be sold over the counter, it must meet the criteria established by the FDA. Over the years, the FDA has made amendment after amendment to the original Food, Drug, and Cosmetic Act of 1938, which was the first piece of legislation to require that drugs be cleared by the U.S. Food and Drug Administration before they could be marketed for human use. In 1951, an amendment was made to the Act which established the distinction between prescription and non-prescription drugs. In short, this amendment basically stated that if a drug product was unable to be labeled with accurate instructions on how to use it safely, it was to be available by prescription only. Another amendment was added in 1962, requiring OTC drugs to be effective for their intended uses[3].

In more recent years, the FDA has used a reclassification process in order to allow products previously indicated as prescription drugs to be sold as non-prescription drugs. There are three ways this change can be administered. (1) The FDA itself is allowed to file a petition for reclassification if it is determined that prescription status is not required for the safe use of the drug. (2) If new clinical research provides information that allows a drug to be approved for an OTC indication or at OTC dosage levels, a New Drug Application (NDA) may be filed by the manufacturer. (3) A supplement to the original NDA may be filed if favorable post marketing safety experience for a product provides evidence that the drug product may be safely used without the supervision of a physician[4].

While there are also several specific drug approval regulations, including formulation, chronic treatments, etc., hopefully this article will assist you in understanding that the phrase over-the-counter should not necessarily be taken literally.

Three OTC Quick Facts[5]:

1. Non-prescription drugs account for 60 percent of all medications used in the United States.
2. Criteria that allow a prescription drug to be reclassified as an OTC drug include the following: similar indications for both prescription and nonprescription uses, easy diagnosis and monitoring by the patient, and favorable adverse-effect and drug-interaction profiles.
3. Switching a product from prescription to over-the-counter status permits the drug manufacturer to market the product for several more years without generic competition.

Sources:
[1] Dessen, Moses, and Rossitto. "Information About Over-The-Counter Drugs Malpractice." DMS-Lawyers. 28 May 2006. Web. 31 July 2009. http://www.dms-lawyer.com/area/otc.shtml
[2] Dessen, Moses, and Rossitto. "Information About Over-The-Counter Drugs Malpractice." DMS-Lawyers. 28 May 2006. Web. 31 July 2009. http://www.dms-lawyer.com/area/otc.shtml
[3] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html
[4] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html
[5] Jacobs, Lori R. "Prescription to Over-the-Counter Drug Reclassification." American Family Physician. The Medicine Shoppe. Web. 31 July 2009. http://www.aafp.org/afp/980501ap/jacobs.html

Additional Sources:
Cohen, Joshua P., Cherie Paquette, and Catherine P. Cairns. "Switching Prescription Drugs to Over-the-Counter." BMJ. 1 Jan. 2005. Web. 31 July 2009. http://www.bmj.com/cgi/content/full/330/7481/39
"Office of Nonprescription Products." FDA US Food and Drug Administration. U.S. Department of Health and Human Services. Web. 31 July 2009. http://www.fda.gov/AboutFDA/CentersOffices/cder/ucm093452.htm