Biotech Values

[DewDiligence]

Q: What’s in between a prescription drug and an OTC drug?

A: A BTC drug, of course!

http://www.reuters.com/article/marketsNews/idUKN0321859520071003

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FDA Explores Behind-The-Counter Drug Sales

Wed Oct 3, 2007 1:41pm EDT
By Kim Dixon

WASHINGTON, Oct 3 (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 Nov. 14 to hear feedback about the "behind the counter" concept, which could make some drugs now available by prescription drugs more widely accessible to patients.

Currently, only a few behind-the-counter drugs, such as Barr Pharmaceuticals Inc's (BRL) Plan B birth control drug, are available in the U.S., but countries such as the U.K., several other European nations, Australia, Canada and New Zealand use them more widely.

Trade groups for pharmacists backed the effort to expand their role in the health care delivery system.

"We think it's a very wise thing to do," said Charlie Sewell, senior vice president of government affairs for the National Community Pharmacists Association, which represents 23,000 independent, non-chain pharmacist owners, managers and workers. "Other countries have this approach and it's worked fairly well."

A spokeswoman for the National Association of Chain Drug Stores, which represents big chains like CVS Caremark Corp. (CVS) and Walgreen Co (WAG), said the group backs the move as well. [Why wouldn’t they?]

The FDA noted that in other countries, the criteria generally used for so-called BTC status are suitability for self-diagnosis and a low potential for serious side effects and overdose.

"Because pharmacists have the training and knowledge to provide certain interventions, they may be able to ensure that patients meet the conditions for use and educate patients on appropriate use of the drug product," the FDA said in a Federal Register notice.

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.
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