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In reply to the discussion: Holy Shit! New Law: Drug Companies exempt from Lawsuits -Supreme Court Ruling [View all]StrayKat
(570 posts)The link you provided has restricted access. I tried pulling up another source from Google, but had no luck. From articles that reference the study, it seems to be a study from the 1980s that looked at drugs approved of in the '60s - '80s. The problem with generic Wellbutrin (which the FDA did actually rule as bioequivalent and later recall despite still maintaining bioequivalence) is more modern, as are some of the problems making substitutions with other meds. There are also some controversy and reported problems with more breakthrough seizures in some generic epilepsy meds. The 'game' has changed since the 1980s. Even the FDA is considering reworking its bioequivalency standards:
In April, in an 11-to-2 vote, members of the FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology suggested that the agencys confidence intervals for bioequivalence should be narrowed to a range of 90% to 111% from the current range of 80% to 125%, saying the current intervals were not sufficient for generic NTI drugs. Ms. Rice said the agency was considering the recommendation.
-Pharmacy Practice News