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FDA Weighs Behind-the-Counter Drugs

Behind-the-Counter Drugs Would Be Sold by Pharmacists Without Prescriptions

Medically Reviewed by Louise Chang, MD on November 14, 2007
From the WebMD Archives

Nov. 14, 2007 -- For at least the fourth time, federal regulators areconsidering whether pharmacists should be allowed to regularly dispensemedications 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 andover-the-counter medication, which can be bought with no professionalsupervision.

But the new class is once again on the FDA's docket, spurred in part by bigdrug companies looking for a new way to sell prescription products that theagency 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' ordersbut only with screening from pharmacy personnel.

"We haven't decided what the next steps might be," said RandallLutter, 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 easieraccess to medications deemed safe enough that they do not require closesupervision by a doctor.

Cut Drug Costs?

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

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

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

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

Some Drugs Already Behind the Counter

Several drug products are already sold from behind pharmacy counters withouta prescription. One is the emergency contraceptive Plan B. The drug was approvedfor nonprescription sales last year after a long political battle, but it wasrestricted to women 18 years of age and older. It is usually sold from behindthe counter so that pharmacies can verify that patients are old enough topurchase it.

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

Prescription drugmakers are increasingly interested in finding a new way tosell products whose patent life may be coming to a close. Merck & Co. triedin 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 besafe.

Carmen Catzione, president of the National Association of Boards ofPharmacy, said pharmacists could adequately counsel patients about the safe useof drugs if a "BTC" class were created.

"It would be easy to do, if the pharmacists have the time to do it,"he tells WebMD.

But others warned that easing restriction on more drugs would take away akey reason many patients schedule doctors' visits: to get a prescription.

Laurie Tansman, a nutritionist at Mount Sinai Medical Center in New York,warned that more patients will skip regular checkups if they can easily buydrugs without input from doctors. She also said fewer patients would pursuepreventive measures like diet and exercise if they can easily buy a pill for aproblem like cholesterol.

"Increasing access to drugs via 'BTC' is not the answer to betterhealth," she said.

The FDA has also not determined if it can create a new behind-the-counterdrug class on its own, or whether Congress would have to pass a new law to doit.

Show Sources

SOURCES: Randall Lutter, deputy commissioner for policy, FDA. Stephen Giroux, president, National Community Pharmacists' Association. David Spangler, senior vice president of policy & international affairs, Consumer Healthcare Products Association. Laurie Tansman, Mount Sinai Medical Center.

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