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FDA Might Ease Prescription-Drug Rules

The Food and Drug Administration may set up a "behind the counter" system allowing more drugs that presently need a prescription to be sold without one.

In a notice set to be available in today's Federal Register, the agency announced a Nov. 14 hearing to explore "the public health benefit of drugs is available without a prescription but only after intervention by a pharmacist.

Such intervention might need a pharmacist to make sure a patient meets certain criteria to get a particular drug and to instruct the patient how to use it.

Presently, 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, with limiting distribution of Barr Pharmaceuticals Inc. "Plan B" emergency-contraceptive pill to pharmacies that agreed to keep it behind the counter and to involve women to show a photo identification to prove they are age 18 or older.

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

In 2005, an FDA panel of outside medical experts turned down a bid by Merck & Co. and Johnson & Johnson to sell Mevacor, a cholesterol-lowering drug, without a prescription. A number of panel members said the FDA should consider establishing a behind-the-counter system that would allow consumers to buy Mevacor from pharmacists much like the British are allowed to buy 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 consist of 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 as well seeking written or electronic comments on the issue until Nov. 28.

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

The agency said certain logistical questions would need to be addressed, together with pharmacy storage and dispensing of the medications along with questions about whether and how pharmacists may be reimbursed.



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