Competing Policy Windows in Biotechnology: The FDA, the 21st Century Cures Act, and Laboratory‐Developed Tests

In 2014, the U.S. Food and Drug Administration (FDA) proposed taking a more active role in the regulation of laboratoryâ€ developed tests (LDTs). Meanwhile, the U.S. House of Representatives embarked upon the 21st Century Cures initiative to develop legislation to expedite the development of new biotechnology innovations. During that initiative and in the public comments responding to the draft guidance, there was significant disagreement as to whether the increased FDA regulation of LDTs was beneficial or detrimental to biotechnology. Both the FDA guidance document and the 21st Century Cures Act came about due to the opening of a window of opportunity created by the convergence of circumstances. The question is whether the windows of opportunity are competing and how to resolve this competition. This study will investigate these questions through a qualitative case study. It will also provide recommendations for resolving policy disputes involving wicked problems like biotechnology policy.c”Ÿc‰©aeS€aeœ¯a¸­ae”?c­–ca—a £cs„c›¸ao’c«žao‰i¼sFDAa€ 21a¸–coaae²»ae„ˆae³•aeiˆa’Œa®žeaŒa®¤e‡aa»oae£€aeµ‹ae–¹ae³• 2014a¹´, c¾Ža›½e£Ÿa“ e ¯a“ c›‘c £c®ic †a±€i¼ˆFood and Drug Administration, FDAi¼‰ae e®®aœ¨a®žeaŒa®¤e‡aa»oae£€aeµ‹ae–¹ae³•i¼ˆlaboratoryâ€ developed tests, LDTsi¼‰cs„c›¸a…³ae³•e§„a¸Sae‰®ae¼”ae›´c§¯aež cs„e§’e‰²a€‚a¸Žae­¤a Œae—¶, c¾Ža›½a¼—e®®e™¢a¼€a§‹c €ae‰‹a ¯c”¨21a¸–coaae²»ae„ˆae³•aeiˆi¼ˆ21st Century Cures initiativei¼‰, aˆ¶a®sae³•a¾‹a»¥aS e€Ÿae–°c”Ÿc‰©aeS€aeœ¯aˆ›ae–°e?›c¨‹a€‚e¯¥ae³•aeiˆa’Œa…¬a¼—a¯¹FDAaeŒ‡a —e ‰aeiˆcs„a›žao”, eƒ½ei¨e¾¾ao†a „e‡aa¯¹FDAae‰©a¤§c›‘c®iLDTae³•e§„a¸€ao‹cs„a¼ocƒˆao‰e®o, aeŽ¢e®¨a…¶a¯¹c”Ÿc‰©aeS€aeœ¯ae˜¯aeœ‰c›Se?˜ae˜¯aeœ‰a®³a€‚FDAaeŒ‡a —ae–‡a»¶a’Œ21a¸–coaae²»ae„ˆae³•aeiˆao§c”Ÿcs„aŽŸa› eƒ½aœ¨aoŽae‰“a¼€ao†ae”?c­–a¹‹ca—, a Že€…aˆ™c”±a¸ a Œaeƒ…a†µe¶‹aoŽa¸€e‡´e€Œao§c”Ÿa€‚e—®e¢˜aœ¨aoŽ, aeœoa¼sa¹‹ca—ae˜¯a ¦ae­£a­˜aœ¨c›¸ao’c«žao‰cs„aeƒ…a†µ, a»¥a Sa¦‚a½•e§£a†³e?™c§ c«žao‰a€‚aeœ¬ae–‡a°†e€se?‡a®sae€§aeiˆa¾‹c ”c©¶a¯¹e?™ao›e—®e¢˜e?›eiŒe°ƒaeŸ¥a€‚aeœ¬ae–‡a Œae—¶a¹Ÿa¼sae a¾›e§£a†³ae”?c­–co co·cs„aeŽ¨e ae–¹ae³•, ae”?c­–co co·ae¶‰a Sa¾‹a¦‚c”Ÿc‰©aeS€aeœ¯ae”?c­–c­‰ae£˜ae‰‹e—®e¢˜a€‚Ventanas de oportunidad polA­tica rivales en la biotecnologA­a: la FDA, el 21st Century Cures Act y las pruebas desarrolladas en laboratorio En 2014, la AdministraciA³n de Alimentos y Medicamentos de los EE. UU. o FDA propuso tomar un rol mAis activo en la regulaciA³n de pruebas desarrolladas en laboratorio (LDTs). Mientras tanto, la CAimara de Representantes de EE. UU. emprendiA³ la iniciativa 21st Century Cures para desarrollar legislaciA³n para agilizar el desarrollo de nuevas innovaciones de biotecnologA­a. Durante esa iniciativa y en los comentarios pAoblicos que responden al proyecto de orientaciones, hubo desacuerdos significativos para responder la siguiente interrogativa: Â?Fue la regulaciA³n incrementada de la FDA para las LDTs beneficiosa o daA±ina para la biotecnologA­a? Tanto el documento de orientaciA³n de la FDA como el 21st Century Cures Act apareciA³ por la apertura de una ventana de oportunidad creada por la convergencia de circunstancias. La pregunta es si las ventanas de oportunidad estAin compitiendo y cA³mo resolver esta competencia. Este estudio investigarAi estas preguntas a travA©s de un estudio de caso cualitativo. TambiA©n proporcionarAi recomendaciones para resolver disputas polA­ticas acerca de problemas extremos como la polA­tica biotecnolA³gica.