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FDA Weighs Behind-the-Counter Drugs

Behind-the-Counter Drugs Would Be Sold by Pharmacists Without Prescriptions
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Some Drugs Already Behind the Counter continued...

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.

Carmen Catzione, president of the National Association of Boards of Pharmacy, said pharmacists could adequately counsel patients about the safe use of 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 a key 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 buy drugs without input from doctors. She also said fewer patients would pursue preventive measures like diet and exercise if they can easily buy a pill for a problem like cholesterol.

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

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

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