Thursday, October 04, 2007

Regulating DTC for BTC

The FDA is seeking public comments on expanding "Behind-the-Counter" (BTC) status to cover more drugs.
In a notice set to be published in today's Federal Register, the agency announced a Nov. 14 hearing to explore "the public health benefit of drugs being available without a prescription but only after intervention by a pharmacist." (WSJ: See "FDA May Ease Prescription-Drug Rules").
In the Federal Register notice, FDA suggests many questions it would like comment on, including BTC impact on patient access, patient compliance with drug therapy, role and compensation for pharmacists, criteria for BTC status, etc., etc. (read more here).

The FDA does NOT ask about how direct-to-consumer (DTC) advertising of BTC products should or should not be regulated by the FDA.

I covered this issue when Plan B was granted BTC status by the FDA (see "Marketing plan A for Plan B").

Ads for Plan B use the tagline: "I Chose a Condom But it Broke," even though data suggests that this is NOT a big problem or perhaps only a problem for BIG men. Planned Parenthood provides these condom statistics:
"Of 100 women whose partners use condoms, about 15 will become pregnant during the first year of typical use. Only two women will become pregnant with perfect use."

Meanwhile, drug companies have pushed to be able to sell statins "behind the counter."

I can imagine the tagline for DTC ads for BTC Lipitor: "I exercised and ate right, but I still got a heart attack. Next time, take Lipitor!"

My question is: Would FDA apply the same regulations to BTC DTC as it does to Rx DTC? If so, why? If not, why?

Submit your comments to the FDA here [should be available 4 October 2007?]


  1. Anonymous11:15 AM

    Actually, I think that only 1 drug company has pushed to sell statins OTC or BTC--BMS. Unless a product is ready to go LOE, it makes little sense for a drug company to push OTC/DTC. There would be a substantial loss of revenue.

  2. I think Merck also applied for OTC status for Mevacor. Perhaps OTC is too lax, so BTC would be next best.


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