The Federal Food and Drug Administration (FDA) will hold public meetings at the end of this month that will likely have far-reaching implications on the future of prescription drugs. The meetings, on June 28 and 29, 2000, will be held to discuss the FDA’s approach in regulating over-the-counter medications.

The agency is considering a switch from prescription drug status to so-called "over the counter" (OTC) status for diuretics, oral contraceptives, HMG-CoA reductase inhibitors, antihypertensives, antidiabetic drugs, treatments for osteoporosis and asthma therapies, among others.

Originally developed in 1972, the rules for OTC drugs have changed little with regard to their basic requirements. To obtain FDA approval, the drug must be demonstrated to be:

1. Safe- A low incidence of significant adverse reactions or side effects under adequate directions for use as well as a low potential for harm from abuse due to availability and,
2. Effective-The pharmacologic effect of the drug will result in clinically significant relief in a significant portion of the target patient population when used under adequate directions for use and warnings against unsafe use.

Explicit within the regulations has been the requirement that the drug may be used for self-medication WITHOUT the intervention of a healthcare professional. All previous OTC switches have met this criterion. Based on the category of drugs listed in the FDA announcement, it is clear that there is an interest in changing the existing regulations or at least the interpretation by the FDA. It is hard to imagine how patients would manage their use of antidiabetic, antihypertensive and cholesterol-lowering drugs without some intervention by healthcare professionals. Each year a handful of drugs, ranging from antihistamines to antifungals, have been converted. Recent changes occurred with nicotine replacement products, NSAIDs and H₂ blockers. The meeting this month appears to have multiple purposes and multiple advocates for changing the basic set of rules. Manufacturers are interested in broadening the options available to them with regard to switches. Insurers are interested in reducing their costs for prescription drugs. Consumers are interested in having more access to treatment options. Finally, the FDA appears to be interested in lowering the cost of drug therapy by switching drugs to OTC status.

In the previous instances in which a prescription drug was converted to OTC status, the manufacturer initiated the process by petitioning the FDA. There are clear financial incentives for a prescription drug nearing the end of its patent life to be made available without prescription. There are also clear financial incentives to move a prescription drug to the OTC category if its market share is on the decline. Merck and Bristol-Myers Squibb have proposed OTC status for their two aging flagship prescription drugs, Mevacor and Pravachol, respectively. The FDA also appears to be interested in changing the initiation process and is suggesting an interest in initiating the process of an OTC switch in the absence of the drug’s manufacturer support.

Regardless of the outcome of the meetings at the end of the month, the path seems clear. What can we look to in the future?

• Increasing array of prescription-to-OTC switches. This will likely include drugs to treat chronic conditions.
• Increasing reliance on self-medication, including management of chronic diseases such as hypertension, hypercholesterolemia and others
• Increasing home monitoring via laboratory tests previously only available through a physician
• Industry and insurance company lobbying for prescription to OTC switches
• Increased direct-to-consumer advertising
• Increased out-of-pocket expense for drugs (as a result of switch to OTC and loss of insurance coverage) and home monitoring testing
• Increased requests for educational materials by patients, allowing self management.

Unfortunately, the impact of these changes on public health cannot be predicted.

For additional information please visit the FDA website.