2014
DOI: 10.1377/hlthaff.2014.0529
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Existing FDA Pathways Have Potential To Ensure Early Access To, And Appropriate Use Of, Specialty Drugs

Abstract: Specialty drugs are notable among prescription drugs in that they offer the possibility of substantial clinical improvement, come with important risks of adverse events and mortality, can be complex to manufacture or administer, and are usually extremely costly. The Food and Drug Administration (FDA) plays a critical role in ensuring that patients who could benefit from specialty drugs have access to them in a timely fashion. In this article we review the different strategies that the FDA can use to approve an… Show more

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Cited by 15 publications
(25 citation statements)
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“…In this process, the FDA has typically played only a superficial role in decision making. Namely, in recent years the FDA has received approximately 1,000 applications per year and approved about 99.5% of these (Kesselheim et al, 2014; Servick, 2014). …”
Section: Background On the Expanded Access Programmentioning
confidence: 99%
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“…In this process, the FDA has typically played only a superficial role in decision making. Namely, in recent years the FDA has received approximately 1,000 applications per year and approved about 99.5% of these (Kesselheim et al, 2014; Servick, 2014). …”
Section: Background On the Expanded Access Programmentioning
confidence: 99%
“…Critics (Kesselheim et al, 2014; Roth-Cline & Nelson, 2014; Walker et al, 2014) traditionally have argued that while Expanded Access may afford benefits to individual patients, it allows the patients to use the medications without participating in clinical research. Thus, if widely adopted, Expanded Access could undermine public health by diverting resources from randomized clinical trials, (M.…”
Section: Background On the Expanded Access Programmentioning
confidence: 99%
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