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03384aam a2200265 i 4500 001 00536B5A440211EF98CC15ED37ECA4DB 003 SILO 005 20240717010108 008 240710s2021 mau b 000 0 eng d 035 $a (OCoLC)1445738416 040 $a LUI $b eng $e rda $c LUI $d SILO 100 1 $a Toomey, James, $e author. 245 10 $a Too important for the bureaucrats : $b rethinking risk and regulatory presumptions in times of crisis / $c James Toomey. 264 1 $a Boston, Massachusetts : $b American Society of Law & Medicine, $c 2021 300 $a pages [249]-263 ; $c 29 cm 504 $a Includes bibliographical references. 520 $a "The posture of American regulation of medicine is negative--we assume that a new drug is unsafe and ineffective until it is proven safe and effective. This regulatory posture is a heuristic normative principle, a specific instance of the so-called precautionary principle in public health law. It is defensible, if debatable, in many ordinary circumstances. But like many normative heuristics, this negative posture may compel suboptimal decision-making in emergencies, where context-specific decisions must be made and a range of unique values may apply. This Article considers the challenge of emergency normative decision-making--a fundamental challenge of democratic legal design--in the context of authorization of new drugs or vaccines in public health emergencies. I conclude, for the same reasons of political theory that apply in the analogous context of emergency military decision-making, that the President ought to have the authority to deviate from the normative heuristics of our drug law in emergencies. This is so for two reasons. First, because emergency decision-making must happen quickly and decisively, it is best situated in one person. Second, normative decisions are political decisions, and in democracies we make political decisions through electoral processes. If we are to situate emergency decision-making in one person, it ought to be the most broadly democratically responsive federal official--the President. Because, however (and unlike the military context), the President's constitutional authority in public health emergencies is debatable, and the current emergency provisions in our drug laws are inadequate, the federal drug laws should be amended to grant the President clear statutory authority to deviate from the ordinary process of premarket approval where necessary to combat public health emergencies. In short, just as we recognize that war is too important to be left to the generals, notwithstanding their military expertise, we ought to recognize that balancing risk and reward in public health emergencies is too important to be left to the scientists, and value Presidential control over the Food and Drug Administration just as we value civilian control of the Pentagon." 580 $a Offprint: American journal of law & medicine. Volume 47, number 2/3 (July 2021) 650 0 $a Food law and legislation $z United States. 650 0 $a Emergencies $x Law and legislation $z United States. 650 0 $a Decision making $z United States. 787 1 $t American journal of law & medicine $g Volume 47, number 2/3 (July 2021) $x 0098-8588 $w (OCoLC)02242483 941 $a 1 952 $l OVUX522 $d 20240717011652.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=00536B5A440211EF98CC15ED37ECA4DBInitiate Another SILO Locator Search