FDA Considers Behind-the-Counter Category For Drugs That Previously Required Prescriptions

Main Category: Pharmacy / Pharmacist
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 05 Oct 2007 - 9:00 PST

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FDA is considering the value of a new category of drugs known as "behind the counter," the Wall Street Journal reports. The agency is seeking comments on the "public health benefit of drugs being available without prescription but only after intervention by a pharmacist," according to a notice published Thursday in the Federal Register.

BTC drugs -- a status that could be applied to some drugs currently available only with a prescription -- would not require a prescription from a doctor, but pharmacists would have to verify that customers meet certain criteria before selling a drug and also would instruct customers on proper use of the drug (Corbett Dooren, Wall Street Journal, 10/4).

FDA Director of Pharmacy Affairs Ilisa Bernstein said that if "patient[s] can't go see a doctor for some reason, this is a way that they might be able to get the product directly through the pharmacist" (Bloomberg/Chicago Tribune, 10/4). FDA also noted that BTC drugs could increase access for the uninsured (Neergaard, AP/Seattle Post-Intelligencer, 10/3). Bernstein said that the "issue has become ripe," adding, "We've heard from manufacturers, from patients."

The notice in the Federal Register cites several possible concerns, including the effect of BTC drugs on patient access, the role of pharmacists or other health professionals in the process, and whether BTC drugs should require a prescription if safety concerns arise. Bernstein said FDA is "not coming out and saying, 'We think BTC is the way to go, and this is how it should be done.'" She added, "We want to find out more" (Rubin, USA Today, 10/4).

The issue will be considered at a Nov. 14 FDA hearing. The agency also is accepting public comments until Nov. 28. Countries that have BTC classifications include Australia, Canada, New Zealand, Denmark, Germany, Italy, the Netherlands, Sweden and Switzerland (Wall Street Journal, 10/4).

Comments
The American Society of Health System Pharmacists since 1985 has advocated the creation of an "intermediary" category of drugs, USA Today reports. Brian Meyer, director of government affairs for the group, said that with a BTC classification, "patients would have some options, but it would hopefully be constructed to address any concerns about patient safety."

However, David Spanger, director of international affairs at the Consumer Healthcare Products Association, said, "You don't need a class. You've got flexibility in the existing system." Spanger added that manufacturers "can certainly be creative" within the current system, citing Barr Pharmaceutical's Plan B emergency contraceptive pill, which is available without a prescription but requires customers to verify that they are over 18 (USA Today, 10/4).

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