Now US FDA Proposes Behind-the-counter (BTC) Drugs

by Medindia Content Team on Oct 4 2007 7:11 PM

Prescription, over-the-counter (OTC) drugs and now behind-the-counter (BTC). OTC is non-prescription and you buy up based on your own knowledge, whatever it is supposed to be.

BTC, now being proposed by the US Food and Drugs Administration (FDA), is also non-prescription. Only the consumer will have to specifically ask the pharmacist for it, according to a Federal Register notice announced Wednesday. "FDA is exploring the public health benefit of certain drugs being available BTC (behind-the-counter) that were previously prescription medications," it says.

"The issue has become ripe," says Ilisa Bernstein, the FDA's director of pharmacy affairs. "We've heard from pharmacists that this is an issue. We've heard from manufacturers, from patients."

Bernstein emphasized: "We're not coming out and saying we think BTC is the way to go, and this is how it should be done. We want to find out more."

How might BTC drugs affect patient access, What's the role of a pharmacist or other health professional, if safety concerns arise, should BTC drugs go to prescription-only are among the questions the FDA seeks to address as it is soliciting public opinion on the issue.

The American Society of Health System Pharmacists' policy since 1985 has been to advocate the creation of an "intermediary" category of drugs. The Consumer Healthcare Products Association, representing makers of non-prescription drugs and dietary supplements, opposes it.

With a BTC category, "patients would have some options, but it would hopefully be constructed to address any concerns about patient safety," says Brian Meyer, director of government affairs for the pharmacists' group.

David Spanger, senior vice president for policy and international affairs at the non-prescription-drugs organization, says: "You don't need a class. You've got flexibility in the existing system."

Manufacturers "can certainly be creative" on a product-by-product basis, Spanger says. He cites emergency contraceptive Plan B, which is available behind-the-counter without a prescription to anyone 18 and older. The FDA opposed Duramed Pharmaceutical's plan to sell Plan B without a prescription to consumers of all ages.

When an FDA advisory panel met in January 2005 to discuss Merck's application to take cholesterol-lowering Mevacor over-the-counter, many panel members said they wished it could be sold behind-the-counter, the way Zocor, another Merck statin, is in the U.K. The committee voted 20-3 against OTC Mevacor, and the FDA followed its advice and turned Merck down.

In Canada, some drugs are BTC, says Gerry Harrington of Nonprescription Drug Manufacturers Association of Canada (NDMAC).

Many are "old, rarely used things," Harrington says. Among them: iodine, hydrocortisone in a 0.5% concentration and benzocaine to relieve teething pain.