OK, I exaggerate just a smidge. Still, I had to smile this morning when I stumbled upon John Yoo’s 2004 letter to the FDA, supporting the Constitutionality of expeditiously developing generic versions of advanced biologic pharmaceuticals. Jane may be surprised to learn that five years before she ever raised the banner (and cudgel) in this cause, Torture Memo Man had her back.

Writing at the behest of the Generic Pharmaceutical Association (GPhA), through the intercession of Senator Orrin Hatch, Yoo addressed an argument raised on behalf of Big Biopharma to the effect that a pathway to biogeneric development would constitute a government “taking” of proprietary information.

I am neither a lawyer nor a Constitutional scholar, but it’s clear that shooting down the “takings” argument hardly required tortured reasoning. If Big Biopharma had a leg to stand on with this position, it would have successfully stood on that leg 20 years before, in opposing the 1984 “Drug Price Competition and Patent Term Restoration Act.” Better known as the Hatch-Waxman Act, that law created today’s system for approving generic versions of traditional (small-molecule) pharmaceuticals.

In a possible first for a progressive blog, behold John Yoo (who by then had already left DOJ for a post at UC Berkeley) making perfectly good sense:

I understand that there have been proposals to devise a process for approving “generic” versions of drugs derived from living organisms (“biologics”). I have been asked by the Generic Pharmaceutical Association (GPhA) to provide my views on a question that has arisen in connection with these proposals, i.e. whether authorizing the Food & Drug Administration to rely on proprietary data supplied by the branded companies for the original versions of approved biologics (or on the conclusions previously drawn from that data by the FDA) in connection with its consideration of subsequent applications would violate the Fifth Amendment’s Takings Clause. Assuming that the FDA’s use and treatment of such data is comparable to the agency’s use of proprietary data under the Hatch-Waxman Act, in my opinion there would be no violation of the Takings Clause. Any other conclusion would lead one to conclude that the Hatch-Waxman Act itself and the FDA’s application of that Act would violate the Constitution as well. These conclusions are my own and do not represent the views of the University of California.

The arena of generics and biogenerics is rife with strange bedfellows, of course, not least the original alliance of Hatch and Waxman. Their act created a regulatory pathway that has saved hundred of billions of dollars ($734 billion in the last decade, at least according to GPhA). Bedfellowships come and go, however; Hatch co-sponsored the industry-friendly amendment now in the Senate health reform bill that corresponds to the reviled (in these parts) Eshoo amendment in HR 3962. Waxman fought this provision, which confers a lavish 12 years of data exclusivity (concurrent with but distinct from patent protection) for branded biologics; his alternative amendment called for a 5-year exclusivity period, the same as in Hatch-Waxman.

Bedfellow-wise, we also find ourselves called upon to thank David Vitter (R-Bordello) for supporting the Senate version of Waxman’s amendment, along with Sherrod Brown and other less surprising Senate figures. So it goes.

And although no one mentions it much around here, you do realize – no? – who’s silently cheering on the pro-biogenerics movement, in addition to physician and patient groups. Private insurers, given their druthers, wouldn’t shell out a cent for pricey biologics, but to the extent that they must, they would much rather pay (more likely, co-pay) for reduced-price biogenerics. When it comes to biosimilars, those who eschew Eshoo are the enemy of their enemy.

Now that the noxious 12-year exclusivity provision has received the blessing of both Pelosi and Reid, the opposition has its work cut out for it. Yoo’s input long preceded the formation of the current battle lines. He merely affirmed that both the Eshoo and Waxman approaches would be Constitutional. But for that small contribution, perhaps he deserves just the mildest of love-nuzzles from the Lady of the Lake.

ralphbon

ralphbon

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