FDA explores behind-the-counter drug sales

By Kim Dixon

WASHINGTON (Reuters) - The Food and Drug Administration said on Wednesday it may create a new category of drugs that would be available without prescription at drugstores, but only after consultation with a pharmacist.

The FDA will hold a public meeting on November 14 to hear feedback about the "behind the counter" concept, which could make some drugs now available by prescription more widely accessible to patients.

But the effort will meet resistance from heavyweights who market over-the-counter drugs. The Consumer Healthcare Products Association, which represents a wide range of companies from Kimberly-Clark Corp to Johnson & Johnson, opposes a three-tier system.

"We believe the current two-class system is the best system for consumers," said Elizabeth Funderburk, a spokeswoman for the group.

Only a few behind-the-counter drugs, such as Barr Pharmaceuticals Inc's Plan B birth control drug, are now sold in the United States. They are more common in Britain, several European nations, Australia, Canada and New Zealand.

Pharmacist groups in general support the effort to expand their role in the health care delivery system.

"Other countries have this approach and it's worked fairly well," said Charlie Sewell, an official with the National Community Pharmacists Association, which represents 23,000 independent, non-chain pharmacist owners, managers and workers.

The National Association of Chain Drug Stores, which represents big chains like CVS Caremark Corp and Walgreen Co, said the proposal could "offer yet another way for pharmacists to serve their patients."

The FDA said in other countries, criteria generally used for behind-the-counter status are: suitability for self-diagnosis, and a low potential for serious side effects and overdose.

The new access might help patients without health insurance because the medications would otherwise be available only with a prescription, the agency said.

The FDA said it wants input from the drug industry, medical community and advocacy groups about whether some drugs should become available on a behind-the-counter basis, what impact it would have on patients' use, and what criteria a drug would have to meet to be classified as behind-the-counter.

The agency also wants suggestions on what role a pharmacist should play in counseling and monitoring patients' use of a behind-the-counter drug, and what measures would be necessary to ensure patient safety.