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Waxman says that the Hatch-Waxman act does not preclude generic liability

Posted in Generic Drugs

Scalia fans everywhere will cringe at the thought of using an amicus brief filed by Waxman on this issue, but setting that prejudice aside, this is kind of a big deal:

Here’s even more powerful evidence of Congress’s intent: a newly filed amicus brief filed by Senator Tom Harkin (D-Iowa) and Representative Henry Waxman (D-California, and, yes, the Waxman of Hatch-Waxman) in support of Bartlett. Harkin and Waxman, who are represented by Allison Zieve of the Public Citizen Litigation Group, say lawmakers’ intentions couldn’t be clearer. If Congress wanted federal regulation to preclude personal injury suits, it would have said so. It’s no accident that Congress did not, according to the brief.

“The notion that FDA regulation broadly pre-empts design-defect claims against prescription drug manufacturers finds no support in the text or purpose of the FDCA, runs counter to the … provision addressing product liability law and ignores more than 75 years of history in which damages suits and federal drug approval have co-existed,” the brief said. “Congress is well aware of its authority to pre-empt state damages actions, and with respect to prescription drugs, as with (over-the-counter) drugs, it has not done so. Moreover, in recent years, following litigation addressing whether federal regulation pre-empts state-law claims regarding injuries caused by drugs, both chambers of Congress have considered pre-emption of state-law claims concerning drugs. Yet Congress has taken no action to change the historical framework through which state law controls whether injured patients have a tort remedy.”

Source: Victim in SCOTUS generics case has powerful amici: Harkin and Waxman