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Commentary

How safe is too safe?
Matthew W. Strobeck, Tomas Philipson, Adrian H. B. Gottschalk, Ernst R. Berndt, Milken Institute Review, 5-19-06

Philipson and his co–authors have adopted a fascinating working paper from the National Bureau of Economic Research that offers a cost–benefit analysis weighing the societal benefits of accelerated drug approval vs. the costs of unsafe drugs potentially being approved by the agency. They conclude that, by any reasonable measure, declines in drug approval times by the agency—and therefore faster access to new medicines—offer vastly more benefits to consumers than costs.

At the same time, however, they recognize that Congress and the public may place more weight on abstract safety concerns in the absence of a concerted effort to quantify the benefits of medical innovation and educate the public. They conclude by saying that,

...in a world of finite resources, people are effectively forced to place a finite value on their own lives. And the value they placed on accelerated access to new lifesaving and life–enhancing drugs far exceeded the highest estimate of the cost in terms of greater risk of premature death and morbidity. Indeed, the value of accelerated review was so great that one must ask whether additional measures—measures that actually did allow more bad drugs to make the cut—would be justified.

The catch, of course, is that neither the public nor the politicians who represent them have openly acknowledged the relevance of cost–benefit analysis in the context of life and–death medical–policy decisions. Are Americans willing to sacrifice statistical lives in order to maximize an abstraction like social welfare? Perhaps not. But until the debate over prescription drug regulation is put in cost–benefit terms, drug policy is bound to fail society's most basic needs.



Project FDA.
  
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