Prescription not needed for allergy drugs, panel rules
Savings to health insurance companies nothing to sneeze at
Saturday, May 12, 2001
By PAUL RECER
THE ASSOCIATED PRESS GAITHERSBURG, Md. -- Three popular allergy
medications are safe enough to be sold without prescription, a
federal advisory panel ruled yesterday in an unprecedented case
that could save the health insurance industry billions of dollars
but increase costs for many consumers.
Acting on a petition by WellPoint Health Networks of Thousand
Oaks, Calif., the Food and Drug Administration panel recommended
that Claritin, Allegra and Zyrtec be made available over the counter,
without supervision by a doctor.
The vote was 19-4 each for Claritin and Zyrtec, and 18-5 for
Allegra. The FDA is not required to follow the recommendations
of the panel, but usually does so.
Dr. John Jenkins of the FDA said he did not have a timeframe
for a decision in the "very unusual" case. Traditionally drug
companies, not insurance companies, ask for a change, he said.
WellPoint, which could save $45 million a year, had argued that
the allergy medications were safe.
"There is no clinical reason for Claritin, Allegra and Zyrtec
to be maintained as prescription drugs," Robert Seidman, a company
vice president, told the 23-member panel. "They have side effects
similar to a sugar pill." Drug companies countered that the move
would force consumers into a "risky trial-and-error gamble with
their health, their quality of life and their money."
Many people will self-diagnose and treat conditions that need
the attention of a doctor, company executives said. Dr. Robert
Spiegel, vice president of Schering-Plough, maker of Claritin,
said prescriptions are needed to "protect and optimize the public
health." "Insurance companies see a physician visit as a cost
item," said Spiegel. "We see it as an essential part of health
care. Now is not the time to drive patients farther away from
their physicians." The company said later in a statement that
an FDA change without pharmaceutical makers' support would be
a reversal of past agency policy and create legal questions.
The financial implications of the FDA's decision will be huge
for the insurance industry, drug manufacturers and consumers.
Consumers would have to pay the full cost unless the drug companies
lower prices to meet competition. Last year, the three drugs generated
about $4.7 billion in sales. The drugs can sell for more than
$2 a pill.
With a prescription, a patient with insurance can get a month's
supply at the personal cost of a co-pay charge, perhaps as little
as $5. The insurance company then has to pay the balance, $50
to $60. If the drugs are reclassified as over-the-counter, insurance
companies would no longer have to pay for them. In Canada, Claritin
can be bought at stores without prescriptions for significantly
less than the U.S. price.
Seidman said the cost there is about $11 a month and that the
companies should also have competitive prices in America. Jenkins
said the FDA cannot force the companies to continue selling the
drugs. Inappropriate self-treatment could have serious medical
consequences, said Dr. Francois Nader, vice president of Aventis
Pharma AG, maker of Allegra. "Consumers would face a risky trial
and error gamble with their health, their quality of life and
with their money," he said.
Manufacturers pointed to asthma, a serious respiratory condition,
as a disease that patients might try to treat without seeing a
doctor. Nader said WellPoint is pushing for declassification because
it does not pay for over-the-counter drugs and the change could
save the company millions of dollars. But he predicted that "the
short term gain to the insurers would increase the health care
burden" on society.
Pfizer Inc., maker of Zyrtec, did not make a presentation at
the meeting. The allergy drugs are known as second-generation
antihistamines because they dry up allergy symptoms without causing
drowsiness so common with first-generation over-the-counter drugs.
Claritin was approved in 1993, Zyrtec in 1995 and Allegra in
1996. In response to the decision, shares of Schering-Plough finished
trading on the New York Stock Exchange up $1.20, to $38.20. Shares
of Aventis fell $1.22, to $75.53, while Pfizer was off 74 cents,
to $43.
Dr. Robert Meyer of the FDA told the panel that there have been
only a few instances of heart and kidney problems and seizures
among patients taking the drugs, but there is no clear indication
that these adverse events were directly caused by the medication.
In his presentation, Seidman said that second-generation antihistamines
are now on sale without a prescription in 17 countries. He said
U.S. consumers could save money they now spend for doctors' visits
to get prescriptions.
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