FDA tells Procter to go slow
Cincinnati Enquirer: While an FDA committee reviewing Procter & amp; Gamble's testosterone patch for women didn't say no last week, it clearly said, "Slow."
The advisory group wants to see broader, more controlled testing of the "passion patch," which P & amp;G says will restore sexual desire in women whose ovaries have been removed.
There is a fine balance between necessary caution and unneccessary delays in getting needed drugs to market. While a setback to P & amp;G, caution is an appropriate message for drug manufacturers, the FDA itself and even consumers.
Prescription drug use
In recent years, prescription drug use has increased sharply as a wealth of new medications have come on the market and drug companies have feverishly advertised pills for everything from acne to cancer.
A government study released last week showed more than 40 percent of Americans take at least one prescription drug, and one in six takes three or more.
Americans seem more willing to try a drug whose long-term effects may not be known, even for ailments such as acne that are not life-threatening.
That lack of consumer worry may be one reason the FDA committee worried so much over long-term effects for the patch, Intrinsa. One member said she "preferred not to have surprises" like those of a Women's Health Initiative study showing links between other hormonal treatments and heart attack, stroke and breast cancer.
Others said it only made sense to use caution when weighing Intrinsa's modest results.
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