National Consumers League

Some Rx Drugs Going Behind-the-Counter?


By Rebecca Burkholder, VP for Health Policy at NCL

This week I spoke at a Food and Drug Administration public meeting on whether certain drugs should be available without a prescription and sold from “behind-the-counter” with counseling from a pharmacist. This “BTC” class of drugs would make some drugs that were previously available only with a prescription available to consumers without spending time and money on a doctor’s visit. The public meeting was a chance for FDA officials to hear the wide range of arguments both for and against establishing this new class of drugs, and to get a glimpse at the many issues that would be raised with the introduction of a new class of drugs. Some type of BTC or pharmacy class of drugs already exists in many other countries. Canadians, Australians, and residents of the United Kingdom have access to BTC drugs. Should Americans be next?

I'm in favor of the creation of this third BTC class because it would increase patient access to the meds we know they can safely use, after consulting with a pharmacist, to self-treat conditions they can easily diagnose for themselves, like allergies or migraines. However, along with other consumer groups, we have some concerns about how the system would work. There are a lot of questions that still need to be answered. Which drugs can safely be placed behind-the-counter? And how can we ensure that consumers get useful counseling by the pharmacist in a private area? All too often the line at the pharmacy counter is endless, and pharmacists' time too short to provide counseling.

By the end of the day the FDA acknowledged that it was not ready to make a decision regarding a new BTC class of drugs, but that it was helpful to hear the variety of opinions. After reviewing all the comments submitted on this issue, the FDA will consider where to go from here.