Prescription for lower drug costs

June 30, 2000
Web posted at: 10:20 a.m. EDT (1420 GMT)

From staff reports

(CNN) -- Any decision the Food and Drug Administration makes concerning prescription drug regulation could have a major impact on the cost of those drugs to American consumers.

The FDA concluded two days of hearings Thursday on relaxing prescription-only restrictions on a number of medications, including allergy drugs and birth control pills.

"We are very concerned that products available in the over-the-counter market have a very strong track record for safety," said Dr. Robert DeLap of the FDA.

VIDEO CNN's Holly Firfer examines the differences between over-the-counter and prescription allergy medicine Real 28K 80K Windows Media 28K 80K     MESSAGE BOARD Should price be a factor in making some drugs more easily available?     RESOURCES Learn how the FDA decides which drugs need a prescription and which don't

Still, consumers in other countries such as Japan and the Philippines can buy birth control pills off the pharmacy shelf, and Canadians can buy the allergy medication Claritin over-the-counter for less than half the cost Americans pay.

Why are drugs like Claritin and Allegra, particularly valuable for their non-drowsiness properties, still available only by prescription here?

"I think the biggest reason, of course, is the money generated from the prescription side of it," said pharmacist John Carr. "I mean, you can charge much more for a prescription than you can for over-the-counter."

In the United States, there are few price restrictions on prescription drugs, and common fixed health insurance co-pays help to mitigate market pressures that could lower prices. The situation has some calling for government price controls.

"If the pharmaceutical company wants to charge $10,000 for a treatment (the typical cost of the early AIDS drug AZT), they can charge $10,000 and the government has nothing to say," said Independent Rep. Bernie Sanders of Vermont. "I think that is absolutely outrageous."

The average cost of a month’s supply of birth control pills ranges from $25 to $30 by prescription, or nearly $400 a year. Claritin costs $1.94 a day by prescription in the U.S. But Canadians spend 57 cents, and Australians just 43 cents. Another popular allergy drug, Zyrtec, costs $1.62 a day in the U.S. In New Zealand, it’s 58 cents, and in Poland it’s even less -- 20 cents. Allegra costs $2.06 a day in the U.S., but only 98 cents in Mexico and 56 cents in Britain.

"We are getting gouged," said allergist Tim Sullivan. "Another way to look at it is that the U.S. is subsidizing medical care in these other countries where resources are not present to buy these drugs."

Research and development costs for a drug can be $200 million to $300 million "at a minimum in order to prove safety and efficacy (and) to get a license," said Sullivan. "A huge amount of research money preceded our ability to get a hold of these drugs."

Cost containment can’t be the only criteria, FDA warned. Making prescriptions necessary helps to ensure that drugs are safe.

The allergy remedy Seldane, for instance, was marketed as a prescription drug in 1985 but made available over-the-counter in 1997. In less than a year, Seldane was pulled from the market after seven deaths were linked to the drug.

"It turned out to have some very severe drug interactions that were life threatening," said DeLap.

But Claritin, Allegra and Zyrtec are considered safe in many other countries, and do not cause the drowsiness that can pose a hazard to people who have to drive while on the medication.

Most side effects of oral contraceptive use are not serious, but life-threatening complications such as stroke and heart attack are not unknown -- particularly among smokers who are over the age of 35.

If the pill were made available over-the-counter, said gynecologist Robert Hatcher of Emory University, "it would be up to us at that point to come up with much better information in our package inserts to provide people with information on what to watch out for about oral contraceptives."

CNN Medical Correspondent Holly Firfer contributed to this report.

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U.S. Food and Drug Administration
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