Tuesday, June 25, 2013

FDA-Approved Labeling Provides Shield For Generic Drug Makers Even When Side Effects Discovered

Supreme Court:  Generic-Drug Makers Can't Be Sued Under State Law For Design Defects by Lawrence Hurley and Bill Berkrot.  Washington Post.  June 24, 2013.

(1)  About _________% of U.S. prescriptions are filled with generics.

(2)  According to the majority opinion, _______________ could not run against federals laws on labeling prescription medicines whose design has been approved by the FDA.

(3)  A 2011 Court ruling found that branded drugs are ____________ while makers of generics ________.

(4)  The Court agreed that federal law requires generic drugs to the same_______________________.

(5)  What happens under the ruling if a dangerous side effect of the medicine does not come to light until long after it was approved by the FDA and perhaps there is no branded label on the market?

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