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[e-drug] Counterfeit pharmaceuticals-BBC story (3)

E-DRUG: Counterfeit pharmaceuticals-BBC story (3)

My experience in the US is similar - the term "fake" is often used for
drugs containing the proper amount of active ingredient, but which
violates legal restrictions on parallel trade, labelling, or patent
laws.  We may have valid reasons to control the distribution of these
drugs, but to lump them together with fully counterfeit drugs is

In the context of the importation of drugs from Canada, the confusion
almost seems deliberate on the part of the US FDA.  In their
highly-publicized enforcement actions at a few US international mail
centers, the FDA media reports claim that a very high percentage of the
drugs tested were "fake or illegal".  The great majority were as
described in the first paragraph - really violations of parallel trade
laws, but containing the proper ingredients.  The simplification by the 
FDA is an unfortunate aspect of their campaign against imports from
Canada (but that is another story).

The dominant source of truly counterfeit drugs in the US over the past
few years is domestic, not international.  The chalk pills sold as
Lipitor and the saline sold as Epogen are good examples.  

Let's keep the statistics on counterfeits and fakes honest.

Kevin Outterson

Associate Professor of Law
West Virginia University
304 293 8282
LL.M. (Cantab.)
J.D. (Northwestern)
SSRN Author Page:  ssrn.com/author=340746

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