Behind-the-Counter Drug Class Gets Increased Attention

The FDA currently can approve drugs for either prescription or OTC use, but a third "behind-the-counter" (BTC) alternative has gained notice in recent weeks, as lawmakers seek ways to prevent the abuse of common OTC drugs and drugmakers run into hurdles trying to switch their Rx products to OTC status.

Laws governing the FDA do not recognize a BTC class, and it would require legislation to establish such a system. But several recent events have highlighted a growing movement to allow a BTC designation.

These events include recent legislation to restrict popular cold drugs, like Tylenol flu medicine, to behind pharmacy counters. The Combat Meth Act, S. 103, which aims to combat methamphetamine production, would classify drugs containing pseudoephedrine as Schedule V drugs under the Controlled Substance Act. Other Schedule V drugs include cough treatments containing codeine.

On another front, FDA advisers recently voted against approving Merck's bid for an OTC Mevacor (lovastatin), but indicated they could support the cholesterol drug if it were available BTC.