Health care law (including regulatory and compliance issues, public health law, medical ethics, and life sciences), with digressions into constitutional law, statutory interpretation, poetry, and other things that matter
Saturday, September 20, 2003
The Safety of Imported Drugs
An editorial in today's New York Times describes the wackiness of the pharmaceutical industry's global pricing strategy. The FDA seems to be playing into that strategy with stern warnings that drug imports might be contaminated or improperly stored or transported. The FDA's position is predictable: given a choice between consumer choice and consumer safety, they will always go with safety, even when the safety concerns are more theoretical than real. (I don't mean to imply there can't be -- or aren't -- real safety concerns. The FDA has sent a warning letter to CanaRx based on that company's shipment of insulin at room temperature when the drug needs to be kept refrigerated. The real question, though, is what is an acceptable safety margin for drugs purchased at an affordable price, as opposed to drugs that are not purchased or administered properly because they are too expensive.) My hometown of Springfield, MA, is leading the way among state and local governments by pursuing an official policy of Canadian drug purchases for city employees, and Illinois is considering the same thing. Many individuals have been importing their drugs from Canada for years, despite a law that says generally only manufacturers are allowed to import drugs. As the Times editorial says, unfair pricing practices are driving this issue, and both the safety and the pricing problems can be worked out if Big Pharm and the FDA can find the desire to do so.
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