When the food and Drug Administration announced last week that Plan B emergency contraception would be available "over the counter," but would be kept behind the counter because of the drug's 18-and-over age restriction, the decision echoed an idea, long advocated by the American Pharmacists Association (APhA), that two classes of drugs aren't enough.
As it stands, the FDA can approve drugs in two categories: by prescription, which typically requires a doctor's visit, and over the counter, which means the medication is safe enough to sit on shelves next to diapers and batteries. What APhA is arguing for is a third official category, like Britain's "behind the counter" designation, for dozens of drugs that may require some oversight but are safe enough to take without a doctor's written consent. Certain flu medications fall into this category, pharmacists say, as do cholesterol-fighting drugs, some vaccinations and smoking-cessation inhalers. A third category would allow consumers quicker access to drugs and could help lower costs. It would also put more responsibility in pharmacists' hands.
Scott Gottlieb, FDA deputy commissioner, has said he is open to this third way (which would require congressional approval). But the Ameri-can Medical Association, which applauded the FDA's approval of Plan B as an OTC option, so far opposes it. "If pharmacists take on diagnosing, they take on liabil-ity, too," says the AMA's Dr. Edward Langston.