FDA to Consider Drug Category Between Rx and OTC

ROCKVILLE, Md., Oct. 4 -- The FDA will convene a public hearing next month to consider formalizing a dispensing category that would make drugs available without a prescription, but only after consultation with a pharmacist.

The new category -- behind-the-counter -- is used now for the emergency contraceptive Plan B and cold remedies that contain pseudoephedrine. The FDA requires that those medications be kept behind the pharmacy counter and sales are limited to customers who show photo identification.

In a background statement the agency said that several countries, including Canada, England, and Germany, are already using variations of behind-the-counter dispensing.

"Some groups have asserted that pharmacist interaction with the consumer could ensure safe and effective use of a drug product that otherwise might require a prescription," the FDA wrote. "Because pharmacists have the training and knowledge to provide certain interventions, they may be able to ensure that patients meet the conditions for use and educate patients on appropriate use of the drug product."

The FDA said the hearing will address a variety of issues ranging from whether the agency should establish the new dispensing category and access issues to potential safety concerns and record-keeping.

The agency is also seeking comment on reimbursement of behind-the-counter drugs, a possible sticking point since insurance plans reimburse only for prescription drugs.

Comments can be made at www.accessdata.fda.gov.