–Shifting the burden of proof from preapproval to postapproval. The new FDA commissioner Scott Gottlieb is quietly and persistently revamping the FDA to make it easier for drug and device companies to get their products on the market. The news, which is being welcomed by industry, also almost certainly means that more people will be…
The GiveAway Act
December 6, 2016 by Leave a Comment
The 21st Century Cures Act should be called the 21st Century GiveAway Act. The Act may not even deliver on its main attraction– the funding of new research– but will instantly definitely give a regulatory boost to a host of special interests, including drug and device makers. As Michael Hiltzik writes in the LA Times,…
Why Rob Califf Running The FDA May Be Like Nixon In China
September 17, 2015 by 1 Comment
(Updated)– There’s a widespread belief that only a conservative like Nixon could have opened up US relations with China. Any attempt by a Democrat to do the same would have been political suicide, but for Nixon it was politically feasible, and today it is recognized as one of his very few untarnished genuine achievements. I want to suggest that…
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