'Behind Counter' Drugs Proposed

The Washington Times (Washington, DC), November 16, 2007 | Go to article overview

'Behind Counter' Drugs Proposed


Byline: Gregory Lopes, THE WASHINGTON TIMES

The Food and Drug Administration is considering taking doctors out of the picture and allowing certain drugs to be sold by pharmacists without a prescription.

During a daylong meeting on the matter yesterday in Rockville, various interest groups focused the FDA's attention on vaccines and cholesterol-lowering statins. At the end of the day, FDA officials said they aren't ready to decide whether to create a new class of drugs that pharmacists could sell "behind the counter (BTC)." And they wouldn't speculate on when they would make that decision.

"We haven't decided what the next step might be," said Randall Lutter, the FDA's deputy commissioner for policy.

Pharmacist groups back the idea. They argue that BTC access to medicines could help uninsured patients gain access to certain drugs now available only by prescription. The agency also pointed out that variations of BTC drug regulations are in effect in a number of countries, including Australia, New Zealand, Canada, France, Britain, Germany and Italy. In those countries, pharmacists typically are required to verify the patient shows symptoms for the illness the medication treats and to explain how to use the drug properly before dispensing.

Mr. Lutter said greater consumer involvement in health care is driving the FDA's decision to consider selling without a prescription.

"Our interest is driven by an increased trend toward consumer involvement and consumer and patient empowerment in their own decisions and responsibilities that they take for health care," he said. "That is really manifested by the Internet and the changes it has brought about."

But the policy change will meet stiff resistance as one of the country's most powerful health care lobby groups, the American Medical Association (AMA), opposes the plan. …

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