Importation may be here sooner than I expected.LEGAL MOVES
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).
CHANNEL IMPACTS
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!
It seems the president would veto the bill if it allows reimportation. The excerpt below is from white house statement found at
ReplyDeletehttp://www.whitehouse.gov/omb/legislative/sap/110-1/s1082sap-s.pdf
The Administration would also strongly oppose any provision that might be added on the Senate Floor regarding the importation of prescription drugs that does not address the serious safety concerns identified in the December 2004 Department of Health and Human Services Task Force Report on Prescription Drug Importation. The Administration believes that allowing importation of drugs outside the current safety system established by the FDA without addressing these serious safety concerns would threaten public health and result in unsafe, unapproved, and counterfeit drugs being imported into the United States. As a result, if any such importation provision were included in the final version of the bill presented to the President, the President’s senior advisors would recommend that he veto the bill.
Good point. But given the political environment, I see a realistic chance for an override. Keep in mind that yesterday's procedural vote got 63 votes (out of 91) = 69%, which is more than the 2/3 needed to override the President. Not sure how the House would vote.
ReplyDeleteBottom line: Get ready for a wild week of lobbying!
Here's a succint update (as of 5/4/07) on this legislation from Kaiser's e-newsletter:
ReplyDeleteSenate To Hold Final Vote on Prescription Drug User Fee Reauthorization Bill That Includes Drug Reimportation Provision
Adam
What are the new pedigree and track and trace requirements?
ReplyDeleteDear Mr. Anonymous (the most profilic commenter on the site!),
ReplyDeleteUnfortunately, there are 51 answers to your question.
A useful -- but already outdated --summary can be found in this Pharma Commerce article:
Red State, Blue State—and Green, Yellow and Orange, Too
Federal updates can be found on the FDA's PDMA page.
Adam
I think Anon was referring to what the new pedigree requirements are that have been inserted into the federal bill...I'd be interested, too.
ReplyDeleteDear Anonymous #2,
ReplyDeleteI appreciate your interest in my perspective, but hope you understand that I can only provide a certain level of analysis on this (free) blog. Just so you know, I did brief a number of my clients on S.242 in early March.
Adam