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The Drug Approval Pendulum
Applebaum points out that whether the FDA is perceived as a regulatory roadblock that keeps patients from lifesaving drugs (as AIDS activists claimed in the 1980s) or as an industry shill (as Public Citizen claims today), is largely the result of shifting political fashions.
Clearly, caution is now “in.” Patients’ rights re “out.” Risk-averseness is “in.” Hot new research is “out.” “There is no doubt there has been a cultural change,” the director of the FDA’s Office of New Drugs told a reporter last week. And there is no doubt that Congress, along with everybody else, sincerely believes that the change is, will be and should be permanent. How little we know of fashion!
We can only hope that innovation will be “in” again soon.
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