US FDA Considering 'Behind-The-Counter' Drug Status

US FDA Considering 'Behind-The-Counter' Drug Status - Dow Jones


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Drug companies would probably like to be able to sell more drugs without doctors having to give out prescrptions. This seems like it could be a huge boon to the drug industry...


WASHINGTON -(Dow Jones)- The U.S. Food and Drug Administration said Wednesday it is considering the possibility of establishing a "behind-the-counter" system that could allow more prescription drugs to be sold without customers actually having a prescription for them.

In a notice set to be published in Thursday's Federal Register, the agency announced a Nov. 14 hearing on the issue. "The FDA is interested in obtaining public comment as it explores the public health benefit of drugs being available without a prescription but only after intervention by a pharmacist," the agency said.

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n 2005, an FDA panel of outside medical experts turned down a bid by Merck & Co. (MRK) and Johnson & Johnson (JNJ) to sell Mevacor, a cholesterol-lowering drug, without a prescription. Several panel members said the FDA should consider establishing a "behind-the-counter" system that would allow consumers to purchase Mevacor from pharmacists much like the British are allowed to purchase Merck's Zocor, another cholesterol-lowering drug. Most panel members said that, if such a system existed in the U.S., they would have voted to allow Mevacor to be sold without a prescription.

The FDA noted that other countries with behind-the-counter status include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland.