FDA hears pros and cons of BTC in hearing

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FDA heard conflicting opinions on the wisdom of creating a “behind-the-counter” drug class at a Washington hearing Wednesday.

The agency declined to set a deadline for a decision on the matter, for which it is soliciting public comment through Nov. 28. “Our timetable depends on what conclusions we reach internally, based on public comments received today and which might come into the docket,” said FDA deputy commissioner for public policy Randall Lutter, who added that FDA will soon make some “next steps” public.

Pharmacists love the idea, which would make them the mediators of a new class of drugs more restricted than OTC but requiring their sign-off instead of a physician's. Doctors, fearing an erosion of their authority and their ability to monitor treatment, aren't so hot on it. “When a drug product is considered unsafe without supervision, a physician should be responsible for supervising the use of that drug,” said Dr. Joseph Cranston, director of science, research and technology for the American Medical Association (AMA). “There is little scientific evidence to support the need for a third class of drugs, and many questions about the impact of this class remain unanswered. The AMA is concerned that a third class of drugs could have a negative impact on patient access to some drugs, reflect an increase in costs and potentially harm patients.”

Perhaps reflecting ambiguity toward the move among its member companies, Pharmaceutical Research and Manufacturers of America (PhRMA) declined to take a strong stance on the issue one way or another. “PhRMA has not been involved in issues related to over-the-counter or behind-the-counter switches,” said PhRMA SVP Ken Johnson. “However, we believe that pharmaceutical research companies themselves are in the best position to examine the safety profile of any medicine that a company is considering for OTC or behind-the-counter status."

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