Rx to OTC: The Switch Is On : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Self-Diagnosis

Another consideration in deciding whether or not a drug should be available without prescription is whether the condition being treated can be self-diagnosed. Inability to self-diagnose a condition, however, does not automatically preclude OTC status for products intended to treat its symptoms. Several drugs, such as bronchodilators, are marketed over the counter even though the conditions they are used to treat — asthma, in this case — cannot be self-diagnosed. FDA's Cough/Cold Advisory Review Panel recommended that bronchodilators could be marketed over the counter provided they were labeled with the warning stating, "Caution: Do not take this product unless a diagnosis of asthma has been made by a physician."

Most OTC drugs are labeled for the treatment of symptoms, such as sinus congestion, headache, pain, upset stomach, and itching. Consumers can readily recognize these symptoms and select an appropriate product to gain relief, but they may not know what underlying condition is causing the pain, cough or itch they are self-medicating. To help consumers judge when a physician should be consulted if a medical problem is not resolving itself through self-medication, products will carry warnings to consult a physician under appropriate conditions. An OTC hydrocortisone preparation to relieve itching from eczema, poison ivy, insect bites, and other causes, for example, carries the warning, "If condition worsens, or if symptoms persist for more than 7 days, discontinue use of this product and consult a doctor."

Timing of the Switch

The switch process has not been trouble-free. When the OTC drug review began, FDA did not have a clear policy that told industry at what point in the process it could market a product being considered for a switch. As a result, some manufacturers began marketing prescription products without waiting for publication of the panel's recommendation or issuance of FDA's final regulation.

In 1976, FDA published a statement of policy explaining that, unless the agency disagrees with the panel, products under review for the switch could be sold over the counter at the time that the advisory panel's report (called a "proposed monograph") is published in the Federal Register. The drugs must be labeled as the panel recommends in its report or as the agency requires in a tentative final monograph. If at a later time FDA disagrees with the panel because of new or other evidence, the agency can then disallow the switch.

A company can also petition FDA to switch an ingredient from prescription to OTC status or, if the company itself manufactures the drug, it can submit a new drug application (NDA) or supplemental NDA for OTC status for the drug.

On occasion, the agency has rescinded an original decision to approve or disapprove a switch. For example, FDA initially disagreed with a panel recommendation to switch the drug diphenhydramine hydrochloride to OTC status for use as a nighttime sleep aid and antihistamine because more controlled studies were needed to satisfy the agency's concerns about the drug's safety and effectiveness in doses appropriate for OTC use. Twelve studies were submitted that compared diphenhydramine with a placebo. After reviewing the data, FDA concluded that the drug, at specified dosage levels, was safe and effective as an OTC nighttime sleep aid. In a later decision, diphenhydramine was also approved for OTC use as an antihistamine.

The converse has happened as well. In October 1982, FDA proposed OTC availability of the bronchodilator metaproterenol sulfate in a metered-dose inhalation aerosol. The proposal met with criticism from the medical community, particularly because of concerns that young children could be harmed by misusing the inhalers.

The agency agreed that there were some risks associated with self-diagnosis and treatment of asthma and that there was a potential for misuse of the product. It believed, however, that the risks did not outweigh the benefits of easy availability. The agency's required labeling for the inhalers warned that the product should be used only after asthma was diagnosed by a physician.

In May 1983, FDA's Pulmonary-Allergy Drugs Advisory Committee met in a public forum to hear reports and discuss the issue. The committee concluded that the risks of OTC availability outweighed the benefits and recommended that FDA rescind its proposal to make metaproterenol an OTC drug. The agency did so the following month.

More recently, when the drug ibuprofen (Advil, Nuprin and Motrin IB) was approved for OTC sale, some experts wanted the label to carry a warning that it might cause kidney damage in people with preexisting kidney disease. FDA determined at that time that the warning was not needed, but is now reconsidering the need because of recent studies indicating an association.

A similar concern has been raised about the antihistamine Seldane, now being reviewed for OTC status. Unlike other antihistamines, Seldane has the advantage of not causing drowsiness. The drug can, however, cause abnormal heart rhythms in patients who have liver problems or take certain other drugs.

For Sale by Pharmacist Only

Some health professional organizations have petitioned FDA to establish a third class of drugs that would be available without prescription, but only through a pharmacist. Pharmacists would advise consumers about proper use of the drug and serve to identify problems that might arise. In 1974, in connection with an FDA monograph on OTC antacids, some pharmacy organizations commented that such a third class of drugs should be created. Others, including the Department of Justice, objected to a third class of drugs, stating that it would restrain competition, inconvenience the consumer, depart from U.S. economic policy, and cause price increases for the consumer with no attending benefit.

FDA concluded that "no controlled studies or other adequate research data have been supplied to support the position that any class of OTC drugs must be dispensed only by pharmacists in order to ensure their safe use. ... There is at this time no public health concern that would justify the creation of a third class of drugs to be dispensed only by a pharmacist or in a pharmacy."

Whatever the mechanism, it's clear that we can expect many more drugs to be considered for the switch from prescription to over-the-counter sales. In recent years, Americans have become increasingly health conscious and have assumed more responsibility for their health, evidenced by such trends as emphasis on diet and exercise and smoking cessation. This take-charge posture is also becoming apparent in self-treatment.

As John Naisbitt writes in his book Megatrends: Ten New Directions Transforming Our Lives, "Along with new habits, the medical self-help movement has brought an upsurge in self-care. No longer do Americans feel they must run to a doctor for every minor ailment: 75 percent of the people can successfully deal with medical problems without ever walking into a clinic or doctor's office."

James D. Cope, president of the Nonprescription Drug Manufacturers Association, says that self-care with self-medication is the largest component of our health-care system and the least costly.

"Six out of 10 medicines bought by consumers are nonprescription," says Cope, "yet total spending for [these medicines] is less than 2 cents of the U.S. health-care dollar." Cope maintains that in a single recent year, OTC medicines saved the nation $10.5 billion that otherwise would have been spent for prescription drugs, doctor visits, and lost time from work.

The trend toward more switches is generally greeted with enthusiasm by consumers, the drug industry, and many health professionals. Caution remains FDA's watchword, however. The continued success of these switches will depend on consumers' good judgment in using these products correctly and in following label directions and warnings.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.