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Competing Policy Windows in Biotechnology: The FDA, the 21st Century Cures Act, and Laboratory‐Developed Tests
Author(s) -
Myers Nathan,
Steding Catherine E.,
Mikolaj Peter
Publication year - 2018
Publication title -
review of policy research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.832
H-Index - 45
eISSN - 1541-1338
pISSN - 1541-132X
DOI - 10.1111/ropr.12262
Subject(s) - food and drug administration , legislation , competition (biology) , window of opportunity , political science , public administration , microbiology and biotechnology , law , economics , management , engineering , biology , ecology , aerospace engineering
In 2014, the U.S. Food and Drug Administration (FDA) proposed taking a more active role in the regulation of laboratory‐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 During that initiative and in the public comments responding to the draft guidance, there was significant disagreement as to whether the increased FDA regulation of LDTs was beneficial or detrimental to biotechnology.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.