Thursday, May 02, 2013

New Plaintiff Argument Against Generic Drug Preemption Rejected

...And it's from Pennsylvania.  Judge Stanton Wettick, from Allegheny County (who is certainly in the running for most respected CP judge in the state) has issued an opinion, Krelic v. Mutual Pharmaceuticals Co., No. GD-08-024513, slip op. (Pa. C.P. Allegheny Co. April 11, 2013), which addresses and rejects - for the first time that we know of - a new argument against preeption under Mensing.

The new argument is based on something called the "different manufacturers exception" to Hatch/Waxman's sameness requirement.  That's located in the statute at 21 U.S.C. §355(j)(2)(A)(v), and in the FDA's regulations at 21 C.F.R. §314.94(a)(8)(iv).  This regulation applies to mundane things, such as corporate name, and inactive ingredients, which are exempted from the sameness requirement.

In a lengthy discussion, Krelic explains that this exception is not applicable to active drug ingredients, which are not exempt from sameness.  The opinion quotes extensively (pp. 5-8) from a letter report dated February 8, 2012 from the Director of FDA's Center for Drug
Evaluation and Research, (Docket No. FDA-2011-P-0702), which details why this regulation does not authorize any label changes that concern safety or effectiveness.  It also quotes (pp. 8-9) from the defense brief in Mensing, which also dealt with this exception.

The court's conclusion in Krelic "is that the exception does not permit different labeling as to safety and efficacy."  Slip op. at 9.

Maybe we missed it, but to our knowledge Krelic is the first decision to address the "different manufacturers exception" in the preemption context.  Plaintiffs are pretty desperate for arguments, so we wouldn't be surprised to see it cropping up elsewhere.  We wouldn't be surprised if it already has, so in the spirit of "a defense win anywhere helps defendants everywhere" we wanted to let our readers who are interested in generic preemption know ASAP.

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