Competing Policy Windows in Biotechnology

The FDA, the 21st Century Cures Act, and Laboratory-Developed Tests

Bibliographic Data

ID4075310
AuthorsNathan Myers (0000-0001-9213-9218, Indiana State University), Catherine E Steding (Indiana State University), Peter Mikolaj (Indiana State University)
Year2018
Volume35
Issue1
Pages89-119
Publication date2018-01-01
Open AccessYes
TypeARTICLE
VenueReview of Policy Research (JOURNAL)
Journal identifiersISSN: 1541-132X • E-ISSN: 1541-1338
PublisherWiley (PUBLISHER • GB)
DOI10.1111/ropr.12262
OpenAlexW2753444319
LanguageEN
Citations received2
References cited22

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 During that initiative and in the public comments responding to the draft guidance, there was significant disagreement as to whether the increased FDA regulation of LDTs was beneficial or detrimental to biotechnology.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

Biology · Economics · Food and drug administration · Legislation · Management · Political science · Window of opportunity · Biomedical Ethics and Regulation · Engineering · Health Systems, Economic Evaluations, Quality of Life · Law · Pharmaceutical Economics and Policy · Public Administration · Biotechnology

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