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Drug Pricing Lessons in the Aftermath of Makena's Approval

By Karl Thiel


Tuesday, May 3, 2011
Back in June 2006, the FDA launched a formal initiative to get unapproved drugs off the market. That seems like a laudable goal. Over the years there have been some notable cases of unapproved products that resulted in injury or death. A high potency vitamin E injection called E-Ferol used to prevent blindness in premature infants, for instance, resulted in an estimated 40 deaths before it was yanked in 1983. Unapproved formulations of quinine used off-label for leg cramps resulted in 93 deaths before being banned in 2006. But while keeping dangerous medicines from the public is the core of the FDA's mission, some of the negative consequences of that effort have been on display over the last month . . . and served to further tarnish the industry in the eyes of the public.

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