[e-drug] Two drug systems in the U.S. (5)

["Sarah Sellers" <ssellers@jhsph.edu>]

E-DRUG: Two drug systems in the U.S. (5)
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Dear e-druggers~
 
The Utah case finding is informative, however, for those interested in the legal complexities of this issue I would also suggest reading the federal court opinion in the Wedgewood Pharmacy case (which affirms FDA's guidance on compounding as a reasonable interpretation of the federal Food Drug and Cosmetic Act (FFDCA)), Supreme Court Justice Stephen Breyer's dissent in the Western States case mentioned in Richard Parrish's post (addresses global public health concerns associated with compounding not confined to the First Amendment issue) and the brief for the petitioners by Daniel Troy and Alex Azar, II also submitted in the Western States Supreme Court Case (which address FDA's application of the FFDCA to the compounding problem).  I have found these documents merit consideration with regards to the legalities of compounding.
 
Justice Stephen Breyer's dissent makes the logical point that providing exemptions from the FFDCA for compounding under FDAMA "inherently creates risks simply by placing untested drugs in the hands of consumers". The dissenting opinion is joined by The Chief Justice, Justice Stevens, and Justice Ginsburg, and further notes the absence of a clear line that will "distinguish (1) sales of compounded drugs to those who clearly need them from (2) sales of compounded drugs to those for whom a specially tailored but untested drug is a convenience but not a medical necessity".  
 
Sarah Sellers, PharmD MPH
ssellers@jhsph.edu