Importation may be here sooner than I expected.
Senator Dorgan, who wants to save us from beef imports but open our borders to counterfeiters, tacked S.242 Pharmaceutical Market Access and Drug Safety Act of 2007 onto the Senate’s drug safety bill.
And guess what? The Senate voted 63-28 to allow the newly revised bill to proceed! (See Senate OKs Reimportation, Safety Delayed from Ed at Pharmalot.) A full vote is likely next week. The Washington Post claims that the Senate is likely to back drug reimportation.
The dangers of importation are well known to anyone familiar with our convoluted system of drug distribution. Plus, importation won’t even save much money although it will add significant safety risks for patients. But the unfortunate political reality is that 80% of U.S. adults support importation along with all three Presidential candidates from the Senate (McCain, Clinton, and Obama).
The proposed importation bill (S.242) explicitly limits the way a manufacturer can structure its distribution agreements. A manufacturer may have little choice about whether it does business with secondary wholesalers that are known US importers or non-US exporters, regardless of ADR status.
I believe that importation legislation will also create a viable profit stream for wholesalers from parallel trade. These new profits will not be directly controlled by manufacturers, creating a new degree of independence from manufacturer-led fees/discounts for U.S. wholesalers - and potentially more channel conflict.
And if you read the fine print (I did!), the legislation contains significant pedigree and track-and-trace requirements. Hmm, I wonder what magic bullet technology Dorgan will consider?
More to come as the debate heats up next week...
P.S. Yep, that's me as a kid in the photo at the top of the post!