F.D.A. CONSIDERS SWITCHING SOME PRESCRIPTION DRUGS
TO OVER-THE-COUNTER STATUS

WASHINGTON - Spurred by two pharmaceutical companies that
want to take their cholesterol-lowering medications over the counter,
the Food and Drug Administration is considering whether many more
medicines -- from antibiotics to birth control pills -- should be made
available without a doctor's prescription.

Beginning with public hearings on Wednesday and Thursday, the drug
agency will begin a re-examination of the way it regulates
over-the-counter drugs, the first such review in nearly three decades.
The last one, in 1972, created a new system for approving
over-the-counter drugs that enabled more than 600 drugs to switch from
prescription to nonprescription status.

Typically, nonprescription drugs treat mild conditions, like
headaches, colds and athlete's foot. But now, in addition to looking
at infection-fighting agents and oral contraceptives, the agency is
raising a new question: whether patients with chronic conditions, like
high blood pressure, high cholesterol, and osteoporosis, should be
able to treat themselves.

"We are open to the possibility of having more and different kinds of
medicines available to consumers," said Dr. Robert DeLap, the agency
official leading the review.

"The health care environment has changed tremendously in recent
years," Dr. DeLap said. "People are much more interested in self-care,
and in being able to manage their minor conditions
themselves."

But what constitutes a minor condition is a matter of debate, and some
drug safety experts worry that broadening access to medications will
only harm patients, enabling them to take drugs in dangerous
combinations. And in making more drugs available without a
prescription, the drug agency could greatly affect the $100 billion
pharmaceutical industry, changing the dynamic of who pays for
medicines and how much they cost at a time when these issues are at
the center of the political debate in Congress.

Nonprescription drugs are generally cheaper than prescription drugs,
and also save money on doctors' visits. The Consumer Healthcare
Products Association, which represents nonprescription drug
manufacturers, says consumers save nearly $13 billion a year by using
over-the-counter medicines that were once available by prescription
only. But while these drugs cost less, patients, and not insurance
companies, must pay for them.

Agency officials said they are not certain whether or when any
regulations will change, but the review is already generating
controversy.

In all, 55 people are scheduled to testify at this week's hearings,
including drug and insurance company officials, safety advocates,
infectious disease specialists worried about antibiotic resistance and
abortion opponents, who are fighting an over-the-counter birth control
pill, which taken in high doses can be used as a morning-after
contraceptive.

"Anytime you tamper with the health care system, you run into very
emotional responses," said Steve Francesco, a consultant who advises
the drug industry on changing drugs from prescription to
nonprescription status. "The F.D.A. is saying let's throw a rock in
this pond and see where the waves move. I think that's very
courageous, and long overdue."

One case in point is Claritin, the best-selling allergy medication,
which last year generated $2.3 billion of its $2.7 billion in sales
from the United States. Claritin is available in other countries
without a prescription, and Blue Cross of California petitioned the
drug agency to give it over-the-counter status.

A switch would inevitably force the drug's maker, Schering Plough
Corporation, to lower Claritin's price, to make it competitive with
other over-the-counter antihistamines, and the company opposes it. But
health insurers, like Blue Cross, would benefit from such a move
because they would no longer have to pay for the medication.

The drug agency typically does not make a drug over-the-counter unless
the manufacturer requests it. But as the agency reopens the issue of
over-the-counter drug regulation, the Claritin debate is generating
fears within the industry that the longstanding policy will change.

"Pharmaceutical companies have the most detailed knowledge of their
drugs, and they should decide when to make the switch," said Jeff
Trewhitt, a spokesman for the Pharmaceutical Research and
Manufacturers Association, a trade group. "Economics should not play a
role."

But economics does play a role. "What's at stake here is money, and
control and safety," said Matthew Weinberg, an industry consultant.

Before 1972, the F.D.A. did not formally review all over-the-counter
drugs for safety and effectiveness. That year, the agency began to set
standards for the 300,000 to 400,000 nonprescription drugs that were
already available; drugs that met those standards were permitted to
remain on the market. But new medicines had to submit to a formal
review by the agency.

In the years since, a range of medicines, from Rogaine for hair loss
to Aleve for pain to Monistat for vaginal yeast infections, have
switched from prescription to over-the-counter status.

Now regulators must consider whether to add cholesterol-lowering
medication to that list. Next month, the drug agency is scheduled to
convene a panel of scientific experts to evaluate applications from
two drug manufacturers, Merck and Bristol-Myers Squibb, to make
low-dose versions of their anti-cholesterol pills available without a
prescription.

Merck's request comes a year before the patent on its drug, Mevacor,
is due to expire; in seeking to market a 10-milligram dose without a
prescription, financial analysts say Merck is trying to build brand
loyalty and increase profits before a generic equivalent goes on the
market. Mevacor's United States sales dropped to $480 million from
$593 million from 1998 and 1999.

The Bristol-Myers Squibb drug, Pravachol, does not face patent
expiration until 2005. In submitting its application to the F.D.A.,
analysts say, the company is trying to compete with Merck.

Officials at both companies cast the discussion in terms of patients,
not profits. They argue that consumers who are not being treated for
high cholesterol would benefit from easy access to their drugs.

But Dr. Sidney M. Wolfe, who as director of Public Citizen's Health
Research Group, an advocacy organization, is a frequent critic of the
drug agency, said it would be both "dumb and dangerous" to permit
cholesterol-lowering pills to be sold without a doctor's orders.

Unlike a patient who has a headache, Dr. Wolfe said, a patient with
high cholesterol may not have symptoms. A test is needed to detect the
problem, he said, and a doctor is needed to interpret that test and
follow the patient to make certain the cholesterol condition does not
deteriorate into a case of serious heart disease. The drugs also have
the potential to cause liver damage.

For those reasons, some financial analysts are skeptical that the drug
agency will approve the Merck and Bristol-Myers Squibb requests.

If cholesterol sounds like a thorny issue, consider oral
contraceptives. Women's health advocates are expected to argue that
the "morning after pill," which is used for emergency contraception,
should be made available over-the-counter.

But abortion opponents have flooded the drug agency with letters
arguing against any change that would make the birth control pill
readily available to teenagers.

Some have suggested that the agency follow Canada's lead, and create a
category known as "under-the-counter" drugs. These drugs do not
require a prescription but cannot simply be picked up off store
shelves. Instead, the pharmacist would control access, acting as a
buffer between consumers and potentially dangerous medications, said
Dr. Raymond Woosley, chairman of the pharmacology department at
Georgetown University.

"That is a classification we have not had in the past," Dr. Woosley
said, "and I think it is one we should be discussing."