Monday, August 06, 2007

Drug imports are not here...yet

House OKs prescription drug imports, said the headline in a widely syndicated AP story on Friday. Pharmalot led with a similar headline.

These headlines are not really accurate. Nevertheless, drug importation fans continue to fight on, making me fear that this legislation is inevitable.

HR 3161, a massive agriculture bill, was passed on Friday by a vote of only 237-18. Math wizards will note that the total is far less than 435 district total because Republicans essentially boycotted the vote.

Here is the primary drug importation text buried inside the bill:

“SEC. 726. None of the funds appropriated or otherwise made available by this Act for the Food and Drug Administration may be used under section 801 of the Federal Food, Drug, and Cosmetic Act to prevent an individual not in the business of importing a prescription drug within the meaning of section 801(g) of such Act, wholesalers, or pharmacists from importing a prescription drug which complies with sections 501, 502, and 505.”

Obviously, this text is much less intrusive than the primary House importation bill (HR 380), the inaptly named Pharmaceutical Market Access and Drug Safety Act of 2007. H.R. 380, which now has 102 co-sponsors, includes detailed requirements about pedigree and track-and-trace systems. H.R. 380 and its Senate cousin S.242 impose many commercial restrictions on drug makers.

S.242 was undone by an amendment requiring the administration to certify the safety and effectiveness of imported drugs before they can be imported. In contrast, the House voted 283-146 to reject Rep. Jack Kingston's amendment to remove section 726 from the H.R. 3161 bill.

As Senator Vitter’s diversion obsession shows, the fans of importation draw inspiration from Spartan King Leonides: No retreat, no surrender. (Yes, I finally saw 300 this weekend.) So why do I still run into executives who claim not to be preparing for the eventual passage of an importation bill?

1 comment:

  1. FYI, the lawyers at Hyman, Phelps & McNamara posted a good anlaysis of the legislative issues regarding this bill:

    House Passes FDA Appropriations Bill With Drug Importation Provision



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