Amid concerns over the need for more antimicrobials, a new analysis finds these medicines benefited more often from expedited regulatory programs than other types of drugs over the last 35 years, suggesting the Food and Drug Administration is not a roadblock to development.
To wit, 61% of 178 antimicrobials approved between 1984 and 2018 were assessed by the FDA under one or more expedited review programs, while 54% of 887 other medicines were evaluated as part of the same programs during that time. These included priority review, accelerated review, fast track review, breakthrough designation (for unmet medical needs), and orphan designation for rare diseases.
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