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FDA Weighs Behind-the-Counter Drugs

Nov. 14, 2007 -- For at least the fourth time, federal regulators are considering whether pharmacists should be allowed to regularly dispense medications without a doctor's prescription.

Three times since the 1970s, the FDA has rejected the idea of adding a new "behind the counter" class of drugs to existing prescription-only and over-the-counter medication, which can be bought with no professional supervision.

But the new class is once again on the FDA's docket, spurred in part by big drug companies looking for a new way to sell prescription products that the agency has rejected for nonprescription sales.

Agency officials said they're evaluating how -- or if -- to proceed on a new "BTC" class of drugs that patients could access without doctors' orders but only with screening from pharmacy personnel.

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

Several countries, including Canada and the U.K., have "behind-the-counter" drug classes. The idea is to give consumers easier access to medications deemed safe enough that they do not require close supervision by a doctor.

Cut Drug Costs?

In public hearings Wednesday, several groups told officials that moving some prescription medications to "behind-the-counter" status would cut medication costs and save money on doctor visits.

"If we get this right, it will be good for the health care system as well," said Stephen Giroux, president of the National Community Pharmacists Association, a group representing independent pharmacy operators.

But behind-the-counter medications could cut both ways. Companies that sell over-the-counter medications are worried that some of the less-safe products could be restricted.

"We don't need the law to change ... and we don't need a new class of medicines," said David Spangler, senior vice president of policy & international affairs at the Consumer Healthcare Products Association, which lobbies on behalf of over-the-counter drugmakers.

Some Drugs Already Behind the Counter

Several drug products are already sold from behind pharmacy counters without a prescription. One is the emergency contraceptive Plan B. The drug was approved for nonprescription sales last year after a long political battle, but it was restricted to women 18 years of age and older. It is usually sold from behind the counter so that pharmacies can verify that patients are old enough to purchase it.

Cold and allergy medicines containing the decongestant pseudoephedrine are also sold behind-the-counter, but that is because Congress passed a law restricting sales because the drugs can be used to make methamphetamine.

Prescription drugmakers are increasingly interested in finding a new way to sell products whose patent life may be coming to a close. Merck & Co. tried in 2005 to gain nonprescription status for the cholesterol drug Zocor. FDA rejected that bid, saying the company had not proved that over-the-counter sales would be safe.