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Fosamax
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Supreme Court Declines to Review Case About Generic Labeling
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As noted previously, the case involved a California woman who was prescribed a generic version of Fosamax, a medicine used to treat osteoporosis. The labeling of the brand-name drug, which is sold by Merck, was updated in 2010 and again in 2011 to warn about the risk of a femur fracture.
Fosamax
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Supreme Court Declines to Review Case About Generic Labeling
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The U.S. Supreme Court has declined to review a case that highlighted the contentious issue of product labeling and the extent to which generic drug makers are able to independently and quickly act to provide consumers with risk information.
...As noted previously, the case involved a California woman who was prescribed a generic version of Fosamax, a medicine used to treat osteoporosis. The labeling of the brand-name drug, which is sold by Merck, was updated in 2010 and again in 2011 to warn about the risk of a femur fracture. Comparable changes to the generic labels were made six weeks after each update, court documents show.
The woman suffered a fracture, but her doctor was unaware of any side effect warnings that may have applied to the generics, according to court documents. As we noted previously, her lawyer maintained the generic drug makers could have quickly alerted physicians with Dear Doctor letters – a notice about important product updates – but this was not done....
...The issue may now be decided by the FDA, which plans to issue a new rule later this year that would permit generic drug makers to update labeling independently in response to new risk information. The agency proposed the rule in response to the 2011 Supreme Court ruling, although a final version has been delayed amid protests from generic drug makers, which are concerned about increased liability.
For full story: http://blogs.wsj.com/pharmalot/2015/01/21/supreme-court-declines-to-review-case-about-generic-labeling/?KEYWORDS=fosamax
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