What happens when the Food and Drug Administration (FDA) grants an accelerated approval for a prescription drug and postmarketing clinical trials reveal information that would require alterations to the drug's labeling? FDA recently posted draft guidance to assist with this issue.
Specifically, FDA issued DRAFT "Guidance for Industry – Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway" (Draft Labeling Guidance). The Draft Labeling Guidance concerns the indications and usage section of the labeling.
Typically, clinical benefit is verified in the postmarketing studies and, after such verification, the Draft Labeling Guidance should be revised to accurately reflect the population and condition for which there is substantial evidence of safety and effectiveness – and include any new or remaining limitations of use. More importantly, the labeling must be revised if the accelerated approval indication is withdrawn but the drug remains approved for other indications. This is especially true if there are known adverse reactions or issues with the drug's ineffectiveness as to the now-unproven benefits.
The Draft Labeling Guidance provides some examples of proper labeling. Finally, other sections of labeling, such as the adverse reactions or clinical studies sections, should be revised as appropriate.
Because the Draft Labeling Guidance has not yet been finalized, some caution should be exercised in addressing its concerns. Also, the comment period on the document will be expiring soon.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
