FDA Panel OKs Non-Prescription Rogaine Sales
Balding Americans should be able to buy the hair-growth drug Rogaine without a prescription, a panel of scientists told the Food and Drug Administration on Friday.
The FDA advisers voted, 12 to 4, that if Rogaine is well labeled, Americans should be able to follow the instructions to determine if they have the kind of hereditary baldness that the drug can treat.
That same FDA panel last year rejected over-the-counter sales of Rogaine because of fears that people who won’t benefit from the drug would waste their money on it. The panelists said then that a doctor needs to diagnose hair loss.
But Rogaine’s manufacturer, Pharmacia & Upjohn Inc. presented the panel with detailed package labels that explain Rogaine can sometimes help hereditary hair loss--known commonly as male pattern baldness--but not any other kind of hair loss.
A Rogaine prescription costs about $60 a month. The company said Friday that an over-the-counter version will cost between $20 and $30 a month. Studies in men who use Rogaine for 12 months show 48% say their hair grew back moderately or better, Pharmacia & Upjohn said.
About 36% had minimal new growth and 16% didn’t benefit at all.