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Over-the-counter (OTC) drugs (drugs that are available to consumers without a prescription) play an essential role in our health care system today. From 2002 to 2012, retail spending on OTC drugs has more than doubled. 1 There are more than 80 therapeutic categories of OTC drugs to treat a variety of ailments. OTC medicines often do more than relieve aches, pains and itches. Some can prevent diseases like tooth decay or cure diseases like athlete’s foot. As with prescription drugs, divisions within the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) oversee and regulate OTC drugs. 2
Over-the-counter (OTC) medicines are sold directly to consumers without a prescription. There are approximately 800 OTC active ingredients available today that constitute more than 100,000 OTC products in the healthcare marketplace. The FDA requires a wider margin of safety for OTC medicines than for prescription drugs. OTC medicines are generally considered safe and effective when used as directed, and the Drug Facts label (label on the packaging) instructs consumers on how to properly choose and use them. They should not be confused with dietary supplements (vitamins, minerals, herbals, and botanicals) which have different rules that will addressed here in the near future.
There are two types of drugs in the U.S.: prescription and nonprescription (OTC). Both must be safe and effective for their intended use and approved by FDA. OTC medicines differ from prescription drugs in the following ways: 3
Margin of safety: Since their intended use is not supervised by a doctor or other prescriber, OTC drugs need to have a wider margin of safety than prescription drugs.
Labeling: By law, OTC medicine labeling must include all the information that an ordinary consumer needs for the safe and effective use of the product. Drug Facts (the panel on the back or side of OTC medicine packages) is the name given to the type of label format on the majority of OTCs.
Advertising: FDA oversees prescription medicine advertising. In contrast, the U.S. Federal Trade Commission (FTC) has authority over OTC medicine advertising, just as it does for other consumer products in order to ensure that ads are not misleading or deceptive.
Distribution: The majority of OTC medicines can be sold in any retail outlets in the United States, including supermarkets, mass merchandisers, pharmacies, etc. Contrary to the case with OTC medicines, prescription drugs are limited to sale in pharmacies.
Over-the-counter (OTC) drugs are developed under the OTC Monograph Process or through the New Drug Evaluation (NDA) Process. FDA’s review of OTC drugs is primarily handled by the Center for Drug Evaluation’s Office of Drug Evaluation IV.
A sponsor (drug company) seeking to market its product OTC, either as a new NDA or as a switch from a prescription product (Rx to OTC switch see below), applies to the Division of Nonprescription Clinical Evaluation (DNCE) in the Office of Drug Evaluation IV. DNCE will oversee drug development, including the review and regulatory action on Investigational New Drugs (INDs) similar to the situation with prescription drugs. After a sponsor submits an NDA, DNCE reviews the consumer studies, the post marketing safety data, the OTC labeling, and any regulatory issues. Additional input is obtained as needed from other disciplines outside of DNCE, including, clinical pharmacology, statistics, and chemistry.
In 1972, the U.S. Food and Drug Administration (FDA) developed the OTC Review to review the safety (how safe is it to take a drug) and efficacy (how effective is the drug) of OTC ingredients, doses, formulations, and labeling used in medicines available to consumers without a prescription. The OTC Drug Review is an important part of drug regulation. The OTC Drug Review’s focus is to enhance the safety, effectiveness, and appropriate labeling of drugs sold without a prescription from a licensed healthcare prescriber. It establishes a way for OTC drug products to come into market without individual FDA evaluation and approval. The Over-the-Counter (OTC) Drug Review was established to evaluate the safety and effectiveness of OTC drug products marketed in the United States. It is a three-phase public rulemaking process (each phase requiring a Federal Register publication) resulting in the establishment of standards (drug monographs) for an OTC therapeutic drug class. 5
Due to the vast number of OTC products, it is not feasible for the FDA to do individual product reviews as is the case with the NDA regulatory pathway. A therapeutic category system, based on active ingredients, was established in an effort to create an efficient review process. The results of the OTC Drug Review were OTC drug monographs. Each OTC drug monograph is a kind of “recipe book” or standards covering acceptable ingredients, doses, formulations, labeling, and, in some cases, testing parameters. OTC drug monographs are continually updated to add additional ingredients and labeling as needed. Products conforming to a monograph may be marketed without FDA pre-approval.
The Division of Nonprescription Regulation Development (DNRD) in the Office of Drug Evaluation IV is responsible for the development of the OTC drug monographs. Data presented to support the safety and efficacy of different active ingredients in a particular drug monograph are reviewed by appropriate scientific personnel. So, while DNRD is considered to be the lead division in the development of an OTC drug monograph, reviewers from multiple divisions within the Office of New Drugs (OND) are involved in this process.
A drug marketed that is consistent with the conditions set forth under a final monograph and all other general applicable OTC requirements is considered generally recognized as safe and effective for the uses set forth under the monograph. 6
The NDA and monograph processes can be used to introduce new ingredients into the OTC marketplace. For example, OTC drug products previously available only by prescription are first approved through the NDA process and their “switch” to OTC status is approved via the NDA process. OTC ingredients marketed overseas can be introduced into the U.S. market via a monograph under a Time and Extent Application (TEA).
Prescription to OTC switch refers to over-the-counter marketing of a product that was once a prescription drug product, for the same dosage form, population, and route of administration. An efficacy supplement demonstrating the effectiveness of a drug should be submitted to an approved NDA for a prescription product if the sponsor (drug company) plans to switch the drug product covered under the NDA to OTC marketing status in its entirety without any changes. An NDA should be submitted if the sponsor is proposing to convert some but not all of the approved prescription intended uses to OTC marketing status or if the drug company plans to market a new product OTC whose active substance, indication, or dosage form has never previously been marketed OTC.
The purpose of a Time and Extent Application (TEA) is to request that active ingredients or botanical drug substance (or combination of both), dosage form, dosage strength, or route of administration be considered for inclusion in the OTC monograph system. Submission of a TEA is only the first step of a two-step process to demonstrate eligibility of the condition for the OTC monograph review process. A TEA should only be submitted for conditions that the applicant believes have been marketed over-the-counter to “a material extent” and “for a material time” as follows:
If the FDA believes that material time and extent has been demonstrated through the TEA, the condition is then declared eligible for the monograph review.
American medicine cabinets contain a growing choice of nonprescription, over-the-counter (OTC) medicines to treat an expanding range of ailments. The U.S. Food and Drug Administration (FDA) determines whether medicines are prescription or nonprescription. The term prescription refers to medicines that are safe and effective when used under a doctor’s care. Nonprescription or OTC drugs are medicines FDA decides are safe and effective for use without a doctor’s prescription.
FDA also has the authority to decide when a prescription drug is safe enough to be sold directly to consumers over the counter. This regulatory process allowing Americans to take a more active role in their health care is known as Rx-to-OTC switch. As a result of this process, more than 700 products sold over the counter today use ingredients or dosage strengths available only by prescription 30 years ago.
Increased access to OTC medicines is especially important for our maturing population. Today’s OTC medicines offer greater opportunity to treat more of the aches and illnesses most likely to appear in our later years. As we live longer, work longer, and take a more active role in our own health care, the need grows to become better informed about self-care. The best way to become better informed is to read and understand the information on OTC labels. Next to the medicine itself, label comprehension is the most important part of self-care with OTC medicines.
With new opportunities in self-medication come new responsibilities and an increased need for knowledge. FDA and the Consumer Healthcare Products Association (CHPA) are great resources in educating the consumer to make better choices when using over-the-counter drugs and making them most effective for you.
For answers to questions about the FDA OTC Regulatory Process go to:
FDA — Frequently Asked Questions on the Regulatory Process of Over-the-Counter (OTC) Drugs: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069917.htm.
CHPA — FAQs About the Regulation of OTC Medicines: http://www.chpa.org/FAQsRegOTCs.aspx.
Or for more information regarding OTC Drugs visit: http://www.yourhealthathand.org/
Consumer Healthcare Products Association; Statistics on OTC use. OTC Retail Sales 1964-2012. Available at: http://www.chpa.org/OTCRetailSales.aspx. Accessed on April 11.2014. ↩
US Food and Drug Administration: About FDA. Regulation of Nonprescription Products. Last updated: January 26,2012. Available at: http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm093452.htm. Accessed on: April 11, 2014. ↩
Consumer Healthcare Products Association; FAQs About the Regulation of OTC Medicines. Available at: http://www.chpa.org/FAQsRegOTCs.aspx. Accessed on April 11.2014. ↩
US Food and Drug Administration: How Drugs are Developed and Approved. OTC (Nonprescription) Drugs. Last updated: January 27, 2014. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ucm209647.htm. Accessed on: April 11, 2014. ↩
US Food and Drug Administration: How Drugs are Developed and Approved. Over-the-Counter (OTC) Drug Monograph Process. Last updated: August 28, 2012. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ucm317137.htm. Accessed on: April 11, 2014. ↩
US Food and Drug Administration: Bringing an Over-the-Counter (OTC) Drug to Market. OTC Drug Monographs. Available at: http://www.accessdata.fda.gov/scripts/cder/training/OTC/topic3/topic3/da_01_03_0100.htm. Accessed on: April 11, 2014. ↩
US Food and Drug Administration: CDER Small Business and Industry Assistance. Small Business Assistance: Frequently Asked Questions on the Regulatory Process of Over-the-Counter (OTC) Drug. Last updated: April 16, 2012. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069917.htm. Accessed on: April 11, 2014. ↩
US Food and Drug Administration: Information for Consumers (Drugs). Over-the-Counter Medicines: What’s Right for You?. Last updated: September 4, 2013. Available at: http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandingover-the-countermedicines/choosingtherightover-the-countermedicineotcs/ucm150299.htm. Accessed on: April 11, 2014. ↩