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Food and Drug Administration • Center for Drug Evaluation and Research |
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Questions and Answers [Docket] [Talk Paper] A Federal Register Notice was published on April 27, 2000 requesting comments from interested persons including scientists, professional groups and consumers. The hearing will be held at the Gaithersburg Holiday Inn, 2 Montgomery Village Ave., Gaithersburg, MD on Wednesday June 28 and Thursday, June 29 from 8:30 a.m. to 4:30 p.m. What is the purpose of the Over-the-Counter Drug (OTC) Products Public Hearing? The primary goal of the hearing is summarized in the last paragraph of the "Background" section of the FR notice: "In light of the continuously changing health care environment, including the growing self-care movement, the agency continues to examine its overall philosophy and approach to regulating OTC drug products. FDA is soliciting information from, and the views of, interested persons, including health professional groups, scientists, industry, and consumers, on the agency’s regulation of OTC drug products." A fairly long list of agency questions follows. Included are questions about what classes of drug products should or should not be available OTC, including examples of some of the many product classes that have been the subject of past comments to the agency. (These examples should not be taken as some sort of list of products that are actually under consideration at the agency.) Why has FDA decided to hold this hearing at this time? FDA's Center for Drug Evaluation and Research (CDER) has received inquiries from the pharmaceutical industry, consumer groups, health care organizations and scientific organizations about issues related to the marketing of OTC drugs. Within FDA, issues have been raised during the OTC Drug Review and in the review of New Drug Applications for the marketing of OTC products that warrant input from all groups with an interest in the marketing of OTC drugs. CDER has decided to obtain input on these issues from all of the stakeholders. How are OTC drugs approved? There are two ways that OTC drugs can be marketed in the US. OTC drugs may be marketed under the provisions of the OTC Drug review (also known as the monograph system), or may be marketed under the terms of an approved New Drug Application. FDA initiated the OTC Drug Review in 1972. This review has examined drug ingredients that have historically been marketed OTC in the US, to verify which of these ingredients can be generally recognized among qualified experts as safe and effective for their intended uses. Through the OTC Drug Review, FDA has established numerous monographs for classes of OTC drug ingredients. Each completed OTC drug monograph considers a particular class of drugs (e.g., antacids, topical antifungal drugs, night-time sleep aids, etc.) and describes the active ingredients that have been determined to be safe and effective through the OTC Drug Review process, with specifications for the amount of drug per dose, formulation, labeling, and other general requirements. As long as a manufacturer uses ingredients (or combinations of ingredients) that are included in the monograph, and follows the monograph specifications in manufacturing and marketing, these "OTC Monograph" products may be sold over the counter without further FDA pre-clearance. Drugs that are not covered under the OTC Drug Review may be marketed OTC under the terms of an approved New Drug Application. Such drugs have almost always been marketed first as prescription drugs; then, after sufficient scientific data and marketing safety experience have been accumulated to assure that the product can be used safely and effectively by consumers without professional supervision, they are "switched" from being prescription drugs, to become OTC drugs (see below). Often, when a new prescription drug product is first marketed, much remains to be learned about the product’s safety and effectiveness. It may take several years to accumulate the information needed to assure that a new drug product can be safely and effectively used by consumers in the OTC marketplace. What determines if a drug is Rx? The 1951 Durham-Humphrey amendments to the act provided specific standards for this determination. As amended, the Act requires that drugs that cannot be used safely without professional supervision are to be dispensed only by prescription. Such drugs may be deemed unsafe for nonprescription use because they are habit-forming or toxic, have too great a potential for harmful effects, or are for medical conditions that can’t be readily self-diagnosed. All other drugs may be sold OTC. A drug is to be made available without a prescription if, by following the labeling, consumers can use it safely and effectively without professional guidance. How are the standards for safety, effectiveness, and labeling for OTC products determined? The standards for safety, effectiveness, and labeling for OTC products are described in 21 CFR 330.10 (a) (4). Safety for OTC use means a low incidence of adverse reactions or significant side effects under adequate directions for use (including warnings against unsafe use), as well as low potential for harm related to any abuse that may occur under conditions of widespread availability. Effectiveness means a reasonable expectation that when the drug is used by consumers as an OTC product (without professional supervision, but with adequate directions for use and warnings against unsafe use), the drug will provide a clinically significant benefit of the type claimed in labeling, for a significant proportion of the consumers who use the product. The benefit-risk ratio weighs the benefits provided by a drug, versus risks or safety problems that may be associated with use of the drug. No drug can be considered to be totally safe. Drugs that are associated with more significant safety problems are expected to have sufficiently greater benefits to justify the increased risk. What are some examples of drugs switched from Rx to OTC ? The FDA has approved the switch of a number of drugs from prescription to OTC status under new drug applications (NDA’s). These include: antidiarrheals (loperamide), topical antifungals (clotrimazole, terbinafine HCL), antihistamines (clemastine fumarate), vaginal antifungals (clotrimazole, miconazole nitrate) analgesics (ketoprofen, naproxen sodium), acid reducers (cimetidine, famotidine) hair growth treatments (minoxidil) and smoking cessation drugs (nicotine polacrilex). Why did the FDA allow the above drugs to be switched from Rx to OTC status? In allowing these drugs to be sold over the counter, the agency considered the safety and effectiveness criteria stated above, the benefit-to-risk ratio, and whether clear and understandable labeling could be written to enable consumers to safely self-medicate without the intervention of a health professional. Does the FDA require the manufacturer to do anything different when their product is switched from Rx to OTC? Manufacturers commonly have been required to conduct labeling comprehension studies to determine if consumers understand the proposed OTC labeling for their products and can use the products in a safe and effective manner. Sometimes the dose of a product to be marketed OTC may be lower than the previous prescription dose, or the proposed OTC use may differ from the prescription use. Then manufacturers may have to do additional studies to evaluate the performance of the product. Examples of other considerations that may require further study before a product may be switched are (1) any potential for abuse of the product, and harm that might be associated with abuse; (2) any interactions with other drugs that may affect safety and effectiveness of OTC use; and (3) any need for more information about the safety and effectiveness of the product in children (especially if the drug is likely to be used in children). Does FDA get many requests to switch products to OTC? FDA has received comments in the past suggesting that a number of additional types of drugs should be considered for OTC status. These suggestions have included antihypertensive agents, cholesterol-lowering drugs, antidiabetic drugs, treatments for osteoporosis, topical agents for the treatment of herpes lesions, problems of the stomach and intestines, asthma treatments, and oral contraceptives. How do consumers gain from having Rx drugs switch to OTC? OTC availability means that consumers have easy access to certain drugs that can be used with acceptable safety, for conditions that consumers can self-treat without the help of a health care practitioner. How many OTC products are available now? More than 100,000 OTC drug products, including more than 800 active ingredients and covering more than 100 therapeutic categories or classes, are available to consumers. From 1995 through 1999, 66 new drugs and/or new uses were approved for OTC marketing. How does the Agency consider comparative safety and effectiveness, in determining which drugs should be available OTC? The American public should have access to the best possible medications. This includes the medications that are available in the OTC marketplace. It is often very difficult, however, to determine which of a series of drugs is "best" for everyone. People are different, and their response to individual drugs can vary. Drugs that are more effective may also have more side effects. For newer drugs, more information about side effects (including rare but serious problems) can always develop as more people use the drug. In general, the Agency has permitted OTC marketing of drugs when there is sufficient information to establish that they are effective and acceptably safe for OTC use. Consumers can then determine the product that works best for them. Companies that market drug products will generally provide information to the FDA to support OTC "switches" of prescription products that appear to be suitable for OTC use. Companies may also periodically discontinue marketing of an older product, e.g. for commercial reasons.
FDA/Center for Drug Evaluation and Research |
