Friday, May 25, 2012

Government Reform (FDA edition)

Via MR, I see that Rand Paul inserted language into FDA legislation recently passed by the Senate which would force the FDA to accept data from clinical investigations conducted outside the United States, including the European Union.  As Paul's press release claims, this would speed the process of getting drugs to market in the U.S., a process that has become increasingly burdensome, and unmatched to the task of reviewing the most advanced treatments.  Alex Taborrak has long advocated for automatic FDA approval of any drug or medical device that gains approval in the EU, Japan, Canada or Australia (I assume he would expand this list if offered the power to write the rules).  I'd be interested to see arguments against.  Is there a reason we shouldn't outsource this decision making, lessening the burden on U.S. govt resources and decreasing the time it takes for important medical treatments to come to market?

1 comment:

  1. http://districthealthadvocates.blogspot.com/2012/05/reforming-fdas-drug-review-process.html

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