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Bipartisan group of senators sponsor a revived drug-importation bill
It is not exactly a bolt out of the blue that certain US Congress members are pushing for a method to allow the importation of drugs from price-controlled countries abroad; the effort was made last year, and in preceding Congressional sessions. But it is surprising—and dismaying—that the same old arguments are trotted out, as if all the complexities of pharmaceutical distribution brought to light during the pedigree wars of the past couple years didn’t exist. “Pedigree”—the set of regulations in force in some states, requiring a paper trail to follow drug shipments through the supply chain from manufacturer to dispenser—gets a bit of a boost, with the ironic outcome that if the new bill becomes law, we may have better tracking of drug movements outside the US than inside it.
But that outcome presupposes a lot of dubious events. The new bill, S.525, “The Pharmaceutical Market Access and Drug Safety Act,” was introduced by Sens. Byron Dorgan (D-ND), Olympia Snowe (R-ME), John McCain (R-AZ) and Debbie Stabenow (D-MI) on March 4. It has 24 cosponsors, and the accompanying news release notes that then Sen. Barack Obama was a cosponsor of an earlier bill (S.242), and that the 2010 White House budget proposal “supports . . . new efforts” for importation.
The bill authorizes the importation of drugs from Canada, Europe, Australia, New Zealand and Japan, whether by direct purchase or through Internet sales. The news release cites estimates from 2005 Congressional Budget Office (CBO) analysis that such importation would save the federal government $6.1 billion in drug outlays, part of around $50 billion for all Americans over the 2006-2015 period. Unlike previous bills, which depended on a certification by FDA and HHS as to exporters’ safety, it mandates FDA inspections of foreign factories (and pharmacies) and sidesteps the certification, which Dorgan’s office calls “merely a poison pill that is designed to be a roadblock to giving Americans access to more affordable prescription drugs.”
An agency (probably FTC) would monitor trade practices to ensure that pharma manufacturers are allowing the unencumbered distribution of drugs into a foreign country (so that they can then be exported to here), and FDA would monitor the drug characteristics to prevent cosmetic packaging changes from restricting US access.
There is a lot of comparable huffing and puffing in the legislation. However, if the same CBO analysis that Dorgan cites is given credence, when all is said and done, US drug prices would be shaved by 1%. And This Bill That Will Not Die overlooks more recent trends:
There are a lot of other interesting elements to this legislation: that FDA would now pre-empt states in inspecting US pharmacies; and that anti-counterfeiting technologies would be applied and would be effective deterrents through multiple regulatory jurisdictions; and that FDA will have a ready-made system to track drug shipments around the world.
Although this bill has 24 cosponsors, a comparable number did so in the previous Congress and that didn’t get the bill to the President’s desk. For now, there is an enormous snarl building in overall healthcare legislation, and the irony of some Congress members pushing for “buy American” legislation while others, in this case, are pushing for a “buy non-American” action at the same time cannot be lost during the current economic implosion. But the pharma industry will have its work cut out for it in forestalling this toxic legislation.