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Importation To Address Drug Pricing? Just Do It – But Don’t Justify It

 
• By Michael McCaughan

The idea of permitting importation of competitors to products like Daraprim has an undeniable appeal, and – unlike essentially every other idea on the table to deal with drug pricing – would actually address the singular example that helped kick off the current debate. But creating a legal framework to justify the action is very perilous for the industry overall. 

Large US American flag on sailboat off the coast of California

Eight years ago, the US FDA responded to outrage over the launch price of a newly approved pre-term labor drug, KV Pharmaceuticals’ Makena, by publicly announcing that it would – in effect – turn a blind eye to continued compounding of the ingredient (hydroxyprogesterone).

That had devastating consequences for the manufacturer, who ultimately went into bankruptcy. (Makena is now marketed by AMAG Pharmaceuticals Inc.). It also undermined FDA’s longer-term policy goals in the field of pharmacy compounding and encouraging fully approved products rather than “gray market” alternatives

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