Yale University

Should benefit-risk assessment have its own drug "label"?

TitleShould benefit-risk assessment have its own drug "label"?
Publication TypeJournal Article
Year of Publication2011
AuthorsBraithwaite, Scott R.
JournalDrug, healthcare and patient safety
Date Published2011
AbstractMany consumers and clinicians incorrectly believe that the Food and Drug Administration (FDA) approval of a new therapeutic implies that its benefits have been proven to exceed its harms. While the FDA could require proof that benefits exceed harms prior to approval, it has been argued that this approach would be infeasible because of prohibitively large sample sizes. One possible alternative would be for the FDA to supplement its standard "label" denoting "safe and effective" with a secondary "label" denoting benefits have been demonstrated to exceed harms, which would be granted only after sufficient post-marketing data had accumulated to prove that its benefits exceeded its harms. This secondary label would not necessarily be linked to marketing restrictions or other commercial prohibitions but, rather, would be only information for consumers and clinicians. Strengths, weaknesses, and feasibility challenges of this approach are discussed.
Alternate JournalDrug Healthc Patient Saf

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