- What is the current drug distribution system in the United States?
- What is a third class of drugs?
- What countries have a third-class or pharmacy-only system?
- Does a third-class or pharmacy-only system work?
- Do any other reputable groups oppose a third or pharmacy class of drugs in the United States?
- Would a pharmacy-class of drugs hasten the switch of prescription drugs?
- Does the recent switch of Plan B create a third class of drugs?
- Does the federal law requiring placement restrictions on pseudoephedrine-containing OTC medicines create a third-class of drugs?
- What is the current drug distribution system in the United States?
The distribution of medicine in the United States is based on a two-class system: prescription and nonprescription medicines. A nonprescription drug is one that the U.S. Food and Drug Administration (FDA) has found to be safe and effective for direct consumer use based on the label instructions and warnings. In the absence of physician supervision, FDA requires a wider margin of safety for nonprescription medicines than for prescription drugs.
The current two-class system of drug distribution empowers consumers with a widening choice of safe and effective medicinal healthcare options conveniently available at competitive prices. This emphasis on consumer empowerment in matters of healthcare directly serves two of the most fundamental demands of any workable healthcare system: access and affordability.
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- What is a third class of drugs?
When most people talk about a third class of drugs, they mean a category of medicines available without a prescription but only in pharmacies or through a pharmacist. These medicines in a pharmacy-only category would not be available in other convenient retail outlets, such as grocery stores without a pharmacy, hotel gift shops, or shops at the airport.
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- What countries have a third-class or pharmacy-only system?
Most developed countries around the world have inherited a pharmacy-only category of medicines and have either significantly or fully limited nonprescription medicines sold outside pharmacies in general retail outlets. These systems arose from historic, centuries-old practice. In Europe, for example, the norm had long been for all medicines to be sold only from pharmacies. These older, European systems predated the modern trend of consumers taking a more active and informed role in their own healthcare decisions.
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- Does a third-class or pharmacy-only system work?
The U.S. Government Accountability Office examined other nations’ experience with a third class of drugs, or pharmacy class, in 1995 and again in 2009. In the 2009 report, the GAO said “we did not find an association between the restrictions place on the availability of particular drugs in our sample by the study countries and the presence of a behind-the-counter drug class. The United States gave more restrictive classification to some drugs and less restrictive classification to other drugs when compared to the other four study countries.” In its 1995 final report to Congress, the GAO concluded that “the evidence . . . tends to undermine the contention that major benefits are being obtained in countries with a pharmacist or pharmacy only class.”
Many countries are slowly expanding access beyond pharmacies to some nonprescription medicines. Japan, the Netherlands, Denmark, Italy, the United Kingdom, and Argentina all have been part of a trend toward granting consumers greater access to medications in more outlets.
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- Do any other reputable groups oppose a third or pharmacy class of drugs in the United States?
Many government agencies and health and consumer organizations oppose a third class of drugs in the United States, including the American Medical Association.
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- Would a pharmacy-only class of drugs hasten the switch of prescription drugs?
No. A third class of medicines would not speed switch, a fact borne out by international experience. Regulatory officials in countries with a pharmacy-only category are neither more nor less likely to switch products from prescription status.
The important aspect for American consumers of switching prescription medicines to nonprescription status, known as Rx-to-OTC switch, is that the U.S. system is a scientifically rigorous process based on data. In the United States, switch comes about when a company submits an application to FDA, supported by clinical studies, labeling studies, and, frequently, actual use studies which seek to replicate real world consumer use as closely as possible. FDA uses all the data—including the drug’s prescription use history—and closely considers the product’s safety, effectiveness, and labeling in making a scientific determination about the regulatory status of that medication. The Agency frequently convenes an outside expert advisory committee for its input about the appropriateness of a switch application.
As a result of this system, consumers have over 80 ingredients, indications, or dosages of formerly prescription medications available without a doctor’s prescription. These include proven safe and effective products such as Prilosec OTC, Claritin, Nicorette, and Advil, just to name a few. A complete list is available online.
Under the U.S. system, medicine makers and the FDA have room for flexibility and innovation, as well. Medicine makers can, and do, develop inventive and novel ways to ensure consumers can have access to even more resources for safe and effective nonprescription medicines. Web site information centers, point-of-sale kiosks, audio tapes, or distribution restrictions are a few examples of approaches in the market today with nonprescription medicines.
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- Does the switch of Plan B create a third class of drugs?
No. Sponsors of switch applications can and should feel free to explore new or different approaches to moving prescription medicines over the counter. There are recent examples in which an application sponsor has voluntarily committed to innovative distribution and educational mechanisms for a product. Supplemental educational materials, web site information centers, etc., are examples of some of the innovative approaches being used by OTC companies to ensure their consumers have access to even more resources for safe and effective self-medication.
Duramed’s application for the switch of Plan B (levonorgestrel), 0.75 mg, is the most recent and prominent example of this. The application voluntarily set up a system whereby consumers 18 and over can purchase the product without a prescription and requires a prescription for consumers under 18. The company agreed to limit distribution through pharmacists-only because the product is labeled for prescription use by women under 18. Federal law prohitibs dispensing a prescription medicine without a prescription.
FDA’s August 24, 2006, approval letter to Duramed and accompanying memos from FDA officials Dr. von Eschenbach and Dr. Galson on Plan B do not make any assertions that FDA’s policy positions have changed regarding the U.S. two-class system.
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- Does the federal law requiring placement restrictions on pseudoephedrine-containing OTC medicines create a third-class of drugs?
No. The federal law imposing placement restrictions on pseudoephedrine- (PSE-) containing OTC medicines is part of the U.S. Drug Enforcement Administration’s (DEA’s) Controlled Substances Act. While FDA maintains that PSE is a safe and effective medication appropriate for over-the-counter sales, the ingredient’s current status reflects the fact that criminal elements are diverting it in order to manufacture the illegal and dangerous drug, methamphetamine. By placing medicines with PSE behind pharmacy or other counters or in locked cases and limiting the amount of product that can be purchased, the DEA in effect is requiring pharmacists and other retailers to assist law enforcement in curbing the criminal production of illicit methamphetamine. It has nothing to do with utilizing pharmacists to provide consumers with any health information regarding the appropriate use of PSE-containing medicines.
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