for the Study of
Healthcare Organizations & Transactions
Switching: Should Prescription Drugs Be Available Over-the-Counter (OTC)?
Introduction The Food, Drug and Cosmetic Act (FDCA) of 1938 (52 Stat. 1040; 21 U.S.C. §301, et seq.) with its amendments is the law that currently regulates drug quality. Under this Act, no new drugs can be marketed until proved safe for use under the conditions described on the label and approved by the Food and Drug Administration (FDA). Also, labels must contain adequate directions for use and warnings about the habit-forming properties of certain drugs (Abood & Brushwood, 1994). However, this act was vague on issues such as what a prescription drug was and who would be responsible for identifying prescription versus non-prescription drugs. This lack of statutory direction created many battles between the FDA, the pharmaceutical industry, and professional pharmacists, as well as within each of these groups.
(Some of the above text as well as the photograph were adopted from a poster on display at the Pharmacy Museum in New Orleans, Louisiana. The poster is from a traveling exhibit that was one product of a 1996 symposium entitled "Medicines: The Inside Story". For more information contact the museum in New Orleans at 504.565.8027.)
What Determines Whether a Drug is a Prescription Drug? The Durham-Humphrey Amendment[§503; 21 U.S.C.§353], enacted in 1951 and known as the Prescription Drug Amendment, resolved the issues left open by the 1938 Act. It established two classes of drugs: prescription and OTC. Prior to the passage of this amendment, drug manufacturers were generally free to determine in which category their drug belonged. A subsection of this amendment granted the FDA the authority to categorize prescription drugs as those that are habit-forming, unsafe for use except under the supervision of a health care practitioner, and/or subject to the new drug application approval process (Abood & Brushwood, 1994).
Who Decides if Prescription Medications are Safe and Effective? A catalyst for additional safety regulation was the thalidomide tragedy in the early 1960s. Thalidomide, a tranquilizer, marketed in Europe during the late 1950s, was responsible for a serious birth defect in thousands of infants. Because the FDA had not approved the use of this drug, it was not distributed in the United States. As a result, the number of birth defects in the United States was very low. Despite this fact, in 1962, Congress enacted the Kefauver-Harris Amendment (also called the Drug Efficacy Amendment) to the 1938 FDCA Act . This Amendment required, during the New Drug Application (NDA) process, that drugs be proved to be both safe and effective. This efficacy requirement applied retroactively, on a case-by-case basis, to prescription drugs that had been approved for use between 1938 and 1962 (Abood & Brushwood, 1994).
Who Decides if OTCs are Safe and Effective? In 1972, the FDA began reviewing those OTCs that were marketed between 1938 and 1962. Rather than reviewing each OTC on a case-by-case basis (as was done for prescription drugs), the FDA decided to review OTC drugs based on therapeutic category and to classify products through rule-making. This approach was adopted for the following reasons (Abood & Brushwood, 1994):
At the time, there were between 100,000 and 500,000 OTC drug products on the market, many of which did not have approved NDAs. The FDA did not have adequate resources to conduct a review on a case-by-case basis.
The litigation that would be required to remove OTC products that were not safe or effective would be time-consuming and expensive.
Nearly all the OTC drugs were derived from only about 200 active ingredients.
The procedures for classifying OTC drugs as safe and effective can be found in Section 21 of the Code of Federal Regulations (CFR), Part 330. The FDA appoints advisory review panels of qualified experts to consider the drugs by class, e.g., antacids, analgesics, and to make recommendations to it. The FDA generally adopts the recommendations of its review panels.
How Does a Prescription Drug Move to OTC Status? A section, (503 (b) (3)), of the Durham-Humphrey Amendment grants the FDA authority to switch prescription drugs to OTC status by regulation. Such a switch may take place when one of the following occurs:
The drug manufacturer requests the switch by submitting a supplemental application to its approved NDA.
The drug manufacturer petitions the FDA.
The drug may be switched through the OTC drug review process.
The primary mechanism of switching drugs to OTC status is the third--the OTC drug review process. As part of the review process, the advisory review panels that were mentioned above, may recommend that a prescription drug be switched to OTC status. If the FDA agrees, it produces a final report on the OTC and the switch from prescription status to OTC takes place (Abood & Brushwood, 1994).
What are Examples of Drugs that have Switched from Prescription to OTC? Since 1972, when the FDA began reviewing OTCs, a range of medicines, such as Rogaine for hair loss, Aleve for pain, Tagamet for heartburn, and Monistat for vaginal yeast infections, have switched from prescription to OTC status (Stolberg, 2000).
The Current Situation:
OTC Medications for Chronic, Asymptomatic Conditions
Approximately 53 million Americans have high levels of cholesterol, however, only a small fraction of those with the worst cholesterol levels use prescription drugs (The New York Times, July 18, 2000, p D10). Of the 53 million people who have high cholesterol, many do not actually know what their cholesterol level is because they have not been tested. Some do know but do not have coverage for prescription drugs either because they have no health insurance or because their insurance does not cover prescription drugs. Finally, many individuals with high levels of cholesterol do not receive the medications that they might need because some physicians do not follow prescribing guidelines (The New York Times, July 18, 2000, p D10).
In July, 2000, the FDA considered whether cholesterol-lowering medications, generally known as statins, should be switched from prescription to OTC status. It convened a panel of scientific experts from two of the FDA's Advisory Committees, the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee (Click on Advisory Panels to see the composition of the Advisory Committees.) Their purpose was to evaluate two applications that were made by two drug manufacturers: Merck and Bristol-Myers Squib (Stolberg, 2000). Merck requested that a 10-milligram dose of its drug, Mevacor, be made available without a prescription. Pravachol, a Bristol-Myers Squib product, was considered at the same time.
Although the National Cholesterol Education Program (NCEP) which is a part of the National Heart, Blood, and Lung Institute, has taken no formal position on whether statins should become available OTC, it has defined a "desirable" level of total cholesterol as being below 200. In the United States, the average adult's total cholesterol is about 205. Both Merck and Bristol-Myers Squib argued that heart attacks occur with some frequency in individuals whose total cholesterol level is higher than optimal but not high enough to warrant prescription medication (between 200 and 240 milligrams per one-tenth liter) and whose levels of low-density lipoproteins (LDL, or bad cholesterol) are 130 or higher. These two drug companies argued that if their drugs were available in lower doses, OTC, coronary heart disease might be reduced because high cholesterol levels are a contributing factor to this disease.
There is growing evidence that some individuals have tried to lower their cholesterol levels by using products such as garlic, fish oil or other dietary supplements. The concern is that these supplements are largely unregulated and have varying levels of effectiveness. By contrast, Hay, et al. (1999) report on the safety, efficacy and cost-effectiveness of statins and urge the more widespread use of them for all individuals with pre-existing coronary artery disease or diabetes mellitus. In addition, they urge more widespread statin use as a prevention measure. The implication is: If individuals are looking for ways to lower cholesterol, perhaps the availability of statins, OTC, may provide a safe and effective alternative to unregulated dietary supplements.
The panel of experts recommended to the FDA that neither Mevacor nor Pravachol be switched to OTC status at this time (The New York Times, July 18, 2000). Both proponents and opponents of the switch to OTC status offered testimony and written opinions. The two sides of the controversy are summarized below with links provided to written comments where available.
Proponents Both the American Medical Women's Association (Click on AMWA Comments to see the full text) and the Association of Black Cardiologists argued that nonprescription therapy might help patients who suffer from heart disease, the leading killer in industrialized nations. Moreover, it was argued that consumers would have access to many more drugs at a lower cost since nonprescription medication generally costs less and also saves on visits to physicians for refill prescriptions.
Opponents The advisors to the FDA raised several points of concern. First, many individuals do not understand cholesterol well enough to treat themselves. The fear was that individuals with very high levels of cholesterol would attempt to treat themselves using OTCs instead of seeing a health care provider. And, since the only sign of high cholesterol is a number on a blood test report, individuals may not be making decisions that are based on adequate information. Second, the FDA advisors were unclear how to ensure that consumers who use OTCs would get blood tests to see if the drugs were indeed working. Finally, drug safety experts argued that broadening access to medications could harm consumers because of the possibility of serious drug interactions.
The Future and Alternatives
It is likely that both Merck and Bristol-Myers Squib will re-apply for OTC status for their respective drugs. Next year, the patent on Mevacor will expire. Once that occurs, generic versions could erode the sales and profitability of Mevacor. Although Provachol's patent expires in 2005, if Mevacor's status switches to OTC, some Provachol users might choose the OTC version of Mevacor. Therefore, both drug makers have incentives to ask the FDA to reconsider their request next year.
Moreover, the issue of whether and to what extent individuals with other chronic disorders such as high blood pressure, and osteoporosis can treat themselves with OTCs is still hotly debated. It is likely that the manufacturers of drugs that are used to treat these disorders will also apply for OTC status.
Finally, women's health groups have advocated that such oral contraceptives as the "morning after pill" which is used for emergency contraception should be available as an OTC drug. However, those groups that oppose abortion argue that such a move would increase teenager's access to and use of birth control pills (Stolberg, 2000).
Is there an alternative to switching prescription drugs to OTC status? Canada currently has a category called "under-the-counter" drugs. Drugs in this category do not require a prescription but neither can they be simply purchased off the shelf. Rather, pharmacists would control their access and individuals who wanted to purchase such drugs would receive counseling by them (Stolberg, 2000). In any case, it is clear that this recent decision by the FDA is most certainly not the last word on the switching of prescription drugs to OTC status.
Abood, R.R., & Brushwood, D.B. (1994). Pharmacy practice and the law. Gaithersburg, MD: Aspen Publishers, Inc.
Food and Drug Administration [on-line] www.fda.gov/opacom/hpchoice.html
Hay, J.W., Yu,W.M. & Ashraf, T. (1999). Pharmacoeconomics of lipid-lowering agents for primary and secondary prevention of coronary artery disease. Pharmacoeconomics, 15(1), 47-74.
Stolberg, S.G. (2000, June 28). U.S. may ease sales of drugs over counter. The New York Times, pp. A1, A19.
The New York Times (2000, July 18). Panel retains status of cholesterol drugs. p D10.
Lucy Canter Kihlstrom, PhD
Copyright © 2000 Institute for the Study of Healthcare Organizations & Transactions
Last modified: 04.08.2010 02:58 PM