title: A review of the progress and pitfalls of FDA policy process: Planning a pathway for pharmaceutical interventions for hearing loss development.
abstract: The Federal Food and Drug Administration, or FDA is generally considered a powerful gatekeeper, able to deliver or withhold life-saving cures and create or destroy economic windfalls. As the decades go by, and technologies, diseases, public health demands, and politics evolve, we can identify patterns of change, action and inter-action among some of these traditional stakeholders in the FDA's policy sphere. A careful examination of this agency's colorful history can shed light on central features of the agency's policy process, which has been quite receptive to its stakeholders and adaptive to change over the decades and, in turn, show the way for development in lanes which do not fit neatly into the current paradigms offered by the agency. This paper will explore the history of FDA policy process, through examination of seminal moments in FDA history, the prominent actors and focusing events within them, and the outcomes of those events, in an attempt to illuminate a pattern of behavior or processes by which a struggling field of pharmaceutical development such as interventions for hearing loss can advance.
authors.affiliation: DOD Hearing Center of Excellence, Research Coordination, 2200 Bergquist Drive, Suite 1, JBSA Lackland, TX, 78236, USA. Electronic address: tanishahammill@gmail.com.
authors.forename: Tanisha L
authors.initials: TL
authors.lastname: Hammill
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence*; D055808:Drug Discovery / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006291:Health Policy / Q000331:legislation & jurisprudence*; D006309:Hearing / Q000187:drug effects*; D034381:Hearing Loss / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D033183:Interdisciplinary Communication; D008887:Military Medicine / Q000331:legislation & jurisprudence; D008889:Military Personnel / Q000331:legislation & jurisprudence; D009784:Occupational Diseases / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D011050:Policy Making; D014481:United States; D059030:United States Department of Defense / Q000331:legislation & jurisprudence; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
keywords: FDA; Hearing loss; Pharmaceutical; Policy