Allan Korn, M.D., senior vice president clinical affairs and Chief Medical Officer of the Blue Cross and Blue Shield Association (BCBSA), today urged the Food and Drug Administration (FDA) to classify a drug as prescription only when it is not safe and effective for the drug to be designated as an over-the-counter (OTC) medication. BCBSA also recommended that the FDA engage in a deliberate process for switching drugs from prescription to OTC status where such designation is safe and effective for the consumer.

In testimony before the FDA, Dr. Korn highlighted the benefits to consumers when the FDA switches appropriate drugs to OTC status. "Today's health care consumers are generally more knowledgeable about their health care and want to take part in making the decisions relating to their treatment," Dr. Korn said. "Switching to OTC also offers consumers the convenience they desire -- they no longer need to visit a physician's office for a prescription."

Dr. Korn cited evidence that when a drug moves from prescription to OTC status, prices quickly move into line with what consumers can afford and are willing to pay.

"It is well known that a competitive market will often drive down costs," Dr. Korn stated. "A good example of this in the OTC market is Zantac 75 (75 mg). Zantac 75, when purchased at a chain drugstore in Minneapolis had a cost of $.28 per tablet, while the average wholesale price for prescription- strength Zantac (150 mg) was $1.77 per tablet."

A study by Brandeis University for the RxHealthValue Coalition, of which BCBSA is a member, shows prescription drug costs for a continuously insured population grew at an annual rate of 24.8 percent per year from 1996 through 1999. Another recent study done for BCBSA by the University of Maryland showed the prescription drug pipeline is at capacity and that new clinical breakthroughs will make up 40 percent of drug costs in the future.

"The danger is that many drugs may become out of the reach of employers and families," Dr. Korn said.

"Revision of the OTC process so that only those drugs which truly need physician supervision are designated as prescription drugs is critical to assuring that coverage is available and affordable for consumers."

The Blue Cross and Blue Shield Association is a federation of independent, locally operated Blue Cross and Blue Shield Plans that collectively provide health care coverage to 75 million -- more than one in four -- Americans. For more information on the Blue Cross and Blue Shield Association, please visit www.bluecares.com