$4 billion price tag? FDA's proposed generic drug labelling rule

An economic consulting group recently published findings that a Food and Drug Administration (FDA) proposed rule will increase annual healthcare costs by $4 billion. The FDA's proposal, announced in November 2013, will allow generic drug manufacturers to update product labelling with new safety information even if the revised labelling differs from that of the reference listed drug (for further details see "Goodbye to generic pre-emption? FDA publishes proposed rule"). The alarming cost increases announced by this recent study provide further support for those who believe that the FDA simply got it wrong this time.

Background -

The FDA's proposed change was a direct response to the Supreme Court's call for action in PLIVA, Inc v Mensing(1). In Mensing, the Supreme Court held that federal law pre-empted state law 'failure to warn' claims against generic drug manufacturers because the Hatch-Waxman Amendments require generics to use warnings that are identical to the brand name's warnings. Recognising that generic pre-emption could leave some plaintiffs without a failure to warn claim, the Supreme Court nevertheless declared that it...

Originally published in International Law Office.

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