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

October 03, 2007:

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.

Currently, most drugs are sold either with a prescription or over-the-counter in retail stores and pharmacies. The agency has carved out a few exceptions including limiting distribution of Barr Pharmaceuticals Inc. (BRL) "Plan B" emergency-contraceptive pill to pharmacies that agreed to keep it behind the counter and to require women to show a photo identification to prove they are age 18 or older. The FDA give permission to Barr last year to start selling Plan B without a prescription.

Some groups who have called for a behind-the-counter status for drugs have said it might allow certain drugs sold with a prescription to be safely sold without one.

In 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 .

Along with a Nov. 14 meeting to solicit public comments on the issue, the FDA said it is also seeking written or electronic comments on the issue until Nov. 28 .

The agency said it wants input on a variety of issues including whether there should be a behind-the-counter status for certain drugs, and whether the status should be a transitional way for prescription products to eventually move to over-the-counter status where consumers can purchase products on store shelves. Other questions include the impact on patient safety and whether it would improve patient access to medications.

The agency said certain logistical questions would need to be addressed including pharmacy storage and dispensing of the medications along with questions about whether and how pharmacists might be reimbursed for their time in dispensing drugs from behind-the-counter.

-By Jennifer Corbett Dooren , Dow Jones Newswires; 202-862-9294; Jennifer.Corbett@dowjones.com

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