There isn't much difference but you can see the line clearly between the FDA attitude toward non-drug products.
When I questioned this the FDA told me their reason was that the consumer had no access to a doctor to be properly informed. I replied to the FDA with a number of statistics indicating that doctors are handing out statins like candy with no information about the risks, as is required by law.
One person I spoke with recently had no idea that the statin drug she had been prescribed promoted liver and kidney failure as well as cancer. She also did not know that the drug delpeted Co enzyme Q 10 and that this could lead to sudden death.
We need an FDA that is more interested in protecting consumer right-of-choice and access in health, not an agency flagrantly ignoring its own (so-called) standards.
FDA weighs over-counter cholesterol drug By LAURAN NEERGAARD, AP Medical Writer
The government is questioning if too many of the wrong people will take cholesterol-lowering Mevacor if it's sold without a prescription, days before Merck & Co. makes its third try to move the drug over the counter.
Merck says selling a low dose of this long-used medication on drugstore shelves, next to the aspirin, could get millions of people at moderate risk of heart disease important treatment that they otherwise may miss.
A preliminary Food and Drug Administration review released Tuesday agreed that nonprescription Mevacor would be "a reasonably safe and effective" option — if consumers used it as directed.
But when Merck tested if consumers could judge who was a proper Mevacor candidate, only 20 percent answered all the questions completely correctly — 50 percent if researchers counted people who said they'd check some things with their doctor before purchasing, concluded FDA's lead medical reviewer.
Moreover, about 30 percent of people who already were diagnosed with heart disease, diabetes or had had a stroke wanted to purchase over-the-counter Mevacor, people who need a doctor's care, the FDA documents say.
The studies "have not convinced this reviewer that there is adequate consumer comprehension of the proposed product label to ensure safe and effective use of this product," the preliminary assessment concluded.
Merck argues that most people made the right decision on whether they should buy OTC Mevacor even if they missed some answers.
On Thursday, Merck will present its case to the FDA's independent scientific advisers, hoping they will recommend that Mevacor become the first in the family of cholesterol-lowering "statin" drugs to be sold in this country without a prescription. Twice before, FDA has said no.
Copyright © 2007 The Associated Press.