Health Business Blog

The FDA is considering adding a formal category of drugs in between prescription and over the counter, as I learned from the USA Today. The new Behind The Counter (BTC) rating would be useful for drugs that require some guidance but not a full-blown doctor visit.

One example where such a category could be useful is statins.

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.

The Consumer Healthcare Products Association opposes the idea, saying there’s enough flexibility in the existing system. Pharmacist groups seems to support the idea.

I’m also in favor of BTC or something like it, especially if the result is more Rx to BTC switches and not a wholesale shift of current OTCs to BTC status. If done right it will also help pull pharmacists into the information loop, which will be good for everyone.

As an aside, I recall about 20 years ago when the movie folks added some new ratings, including PG-13 and NC-17. I remember seeing a spoof, which suggested that as long as the number of rating was being expanded, why not make it even more specific. The one I specifically remember was JLC-N, as in “Jamie Lee Curtis appears naked.”

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