Sparks fly at FDA hearing on behind-the-counter class of drugs

November 16, 2007

At an FDA public meeting to consider whether a behind-the-counter class of drugs should be set up, the agency heard from both supporters and detractors.

The views of both proponents and opponents of a behind-the-counter (BTC) class of drugs were aired at an FDA public meeting held in Washington, D.C., this week. Organized pharmacy is strongly in favor of the creation of a so-called third class of drugs, while other groups are opposed. Among the opponents was GlaxoSmithKline's president George Quesnelle, who stated, "Legislation to create a third class of drugs would unnecessarily limit consumer access to safe, affordable, and effective OTC medicines without any demonstrated benefit." Also expressing reservations was Kirsten Moore, president and CEO of the Reproductive Health Technologies Project, who said, "The FDA should carefully consider whether having a learned intermediary such as a pharmacist would advance quality health care or create an unnecessary barrier." Citing Plan B as an example, Moore said placing it behind the counter has unnecessarily delayed access to this time-sensitive treatment, potentially increasing the risk of unintended pregnancy. On the other hand, APhA argued that a BTC system would improve patient access to care and the knowledgeable counsel of pharmacists.

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