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« The Nexus between Biotechnology and Economic Recovery | Main | More on Data Exclusivity »

January 25, 2011

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Listed below are links to weblogs that reference U.S. Patients Petition FDA to Regulate Genzyme Export of Fabrazyme:

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Interesting story, James. Given that it is U.S. patients and their insurance companies who effectively subsidize drug development for the rest of the world by paying non-government regulated high prices for new drugs, it seems to reasonable to require the manufacturer to keep its product in the U.S. market during times of shortage. Although imposing such a requirement may smack of government over-regulation, such a requirement would prima facie not result in a loss of revenues for the innovator.

This post seems to make a strong case that the fruits of the public money be first given to that particular public that invested that money (through the government programs).

By accepting that money, the drug companies implicitly accepted the constraints that follow.

Other than "it's our choice," what are the possible arguments that the drug company can make to support this "sending most of its Fabrazyme overseas"?

I am reminded of the mock court case commercials against certain airline executives that "love money."

How can one find out when the Framingham manufacturing facility will be approved by the FDA? The "second half of the year" can be anywhere from July 1st to December 31st. Can one call an FDA office to find out when the facility is approved? Or is there a continually updated database of approved facilities?

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