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
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