There's a Blurry Line Between Rx and O.T.C.:
"A popular prescription drug to prevent unwanted pregnancies is safe enough that it should be made available over the counter to the women who urgently need it, an advisory committee to the Food and Drug Administration recommended last week.

The F.D.A.'s commissioner, Mark McClellan, must now decide to accept or reject the finding, and faces an intense debate over the ethics of selling the morning-after pill, called Plan B, as if it were no different from aspirin, for example. But what about the scientific question? If the pill is so safe, and so important, why was it sold by prescription in the first place, as it has been since 1999? "

The decision to sell a drug by prescription, experts say, may involve factors that have nothing to do with science or patient safety. Marketing and financial considerations, politics, doctors' concerns and consumer psychology all may play a role.

"Unequivocally, there is no bright line," said Peter Barton Hutt, a former chief counsel at the F.D.A. who now teaches at Harvard and represents drug companies. "It's a judgment issue."

http://www.nytimes.com/2003/12/21/weekinreview/21kola.html