Busy SCOTUS day for FDA types – the generic drug label pre-emption case is also out (Pliva v. Mensing), with a fractured 5-4 case pre-empting state law. Thomas wrote the majority opinion, finding that state tort law cannot punish a generic manufacturer for using the FDA-approved label. He distinguished the 2009 Wyeth case because generic firms can’t use the CBE process to update labels for emerging safety problems. But Justice Thomas also said the generic firms didn’t even have to ask for changes, even if they knew about safety issues. Don’t ask, don’t tell.
So – generic firms are not liable for failure-to-warn (Pliva), but brand name companies are (Wyeth). Implied pre-emption at it’s finest.
More details and analysis at PharmaLot. Sorrell v. IMS Health post here.
Today’s scorecard: Drug companies 2-0.
UPDATE: A good summary from the FDA Law blog.