One bit of upside to the release of the CMS documents was the way Medicare officials treated use of Provenge that goes beyond the current clinical trial data and the Food-and-Drug-Administration-approved label.
The FDA-approved prescribing label for Bydureon has a prominent warning stating that the drug caused certain kinds of thyroid tumors in rats at clinically relevant exposures in testing, according to the FDA website.
WSJ: FDA Approves Amylin's Bydureon Diabetes Drug After Delays
In other words, instead of one warning label appropriately approved by a federally warranted agency, drugmakers must now gird themselves for warning labels as judged by 50 states and who knows how many other jurisdictions.
In 2009 the court allowed a lawsuit to proceed against Wyeth, a drug firm, for not putting a clear enough warning label on a drug, though its label had been approved by the Food and Drug Administration.
Despite Scharf's advice to his mother, the product label the FDA has approved for Ambien suggests the drug be taken for no more than seven to ten days, and up to three weeks in certain cases.
Would similar off-label use happen if Revimid were approved for another disease?
Presidential candidate John McCain of Arizona and his colleague Joseph Lieberman of Connecticut have proposed a bill to force the show-biz industry to label violent products with government-approved warnings.
The most likely outcome: Pradaxa gets approved at both doses, but with a weak label.
It is not illegal for a doctor to prescribe a drug off-label, that is, for a non-FDA-approved use, but a drug marketer cannot lawfully encourage a doctor to do so.
In December, Sepracor's Lunesta became the first sleeping pill approved without a restriction, limiting its use for a week or so, on its label. (Ambien has such a limitation, though many doctors prescribe it for longer.) Indiplon, being developed by Neurocrine and Pfizer, is likely to get similar labeling.
In December, Sepracor's Lunesta became the first sleeping pill approved without a restriction, limiting its use for a week or so, on its label. (Ambien has such a limitation, though many doctors prescribe it for longer.) Indiplon, being developed by Neurocrine and Pfizer (nyse: PFE - news - people ), is likely to get similar labeling.
She said these drugs are often used off-label (that is: for purposes other than the ones for which the FDA approved them) and that overuse both costs Medicare hundreds of millions of dollars and harms patients.
应用推荐