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Third Class of Drugs Is Bad Idea, Public Citizen Tells FDA

Nov. 14, 2007

Third Class of Drugs Is Bad Idea, Public Citizen Tells FDA

WASHINGTON, D.C. – Allowing patients to obtain certain drugs on the basis of counseling by a pharmacist but without a doctor’s prescription is a bad idea, Public Citizen told the Food and Drug Administration (FDA) today at a public hearing.

Some pharmaceutical companies want to see a third category of drugs on the market, splitting the difference between over-the-counter products that anyone can buy and prescription drugs that require physician involvement. Called “behind-the-counter” drugs, the concept is based on industry’s theory that some prescription drugs are well-known enough, and benign enough, that, with counseling by a licensed pharmacist, a patient should be able to obtain the drug with a self-diagnosis and without a doctor’s opinion. The problem is, it’s neither a new nor a good idea, Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, told the FDA staff that held the hearing.

Many countries have introduced a third class of drugs, and evidence shows it did not work, Wolfe told the panel. In 1995, the General Accounting Office (GAO) conducted a study of 10 countries (Canada, Australia and eight European nations) where behind-the-counter drugs were permitted. Called “Nonprescription Drugs: Value of a Pharmacist-Controlled Class Has Yet to Be Demonstrated,” the data showed that counseling by pharmacists was infrequent and incomplete, did not increase the public’s access to drugs and had no effect on costs. This was the last comprehensive review of this subject.

In 1990, Congress passed a law requiring pharmacists to offer information to people filling prescriptions. Ten years later, another GAO study showed it was relatively ineffective. Wolfe concluded that the behind-the-counter drug proposal would not serve the public interest; to the contrary, it would put the public at risk.

“Pharmacists are well-skilled and often know a lot about the drugs they dispense,” Wolfe said. “In practice, though, when asked to counsel, they often don’t because they don’t have the time, and no mechanism exists to reimburse them for their time.”

READ Wolfe’s testimony.