FDA considers a third drug category: Behind-the-counter

Such drugs would be available without a prescription but only after asking a pharmacist for it, according to a Federal Register notice announced Wednesday. quot;FDA is exploring the public health benefit of certain drugs being available BTC (behind-the-counter) that were previously prescription medications,quot; it says. p>The FDA will seek public response at a meeting in Washington Nov. 14 and accept written comments until Nov. 28.p>quot;The issue has become ripe,quot; says Ilisa Bernstein, the FDA's director of pharmacy affairs. quot;We've heard from pharmacists that this is an issue. We've heard from manufacturers, from patients.quot;p>Bernstein emphasized: quot;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.quot;p>The FDA raises many questions about the concept in the Federal Register. They include:p>bull;How might BTC drugs affect patient access?p>bull;What's the role of a pharmacist or other health professional?p>bull;If safety concerns arise, should BTC drugs go to prescription-only? p>The American Society of Health System Pharmacists' policy since 1985 has been to advocate the creation of an quot;intermediaryquot; category of drugs. The Consumer Healthcare Products Association, representing makers of non-prescription drugs and dietary supplements, opposes it.p>With a BTC category, quot;patients would have some options, but it would hopefully be constructed to address any concerns about patient safety,quot; says Brian Meyer, director of government affairs for the pharmacists' group.p>David Spanger, senior vice president for policy and international affairs at the non-prescription-drugs organization, says: quot;You don't need a class. You've got flexibility in the existing system.quot;p>Manufacturers quot;can certainly be creativequot; 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.p>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.p>In Canada, few drugs are BTC, says Gerry Harrington of NDMAC, the country's counterpart of Spanger's group. Many are quot;old, rarely used things,quot; Harrington says. Among them: iodine, hydrocortisone in a 0.5% concentration and benzocaine to relieve teething pain./>