Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format
September 14, 2018
Re: Docket No. FDA-2018-D-1895: Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format
Dear Sir/Madam:
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments to the Draft Guidance titled Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products —Content and Format.
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.
BIO applauds FDA’s issuance of the draft guidance to provide recommendations on the general principles to consider when drafting an indication and how to write, organize, and format the information in the Indications and Usage section of the labeling. In particular we commend the FDA for recognizing that an indication for a “broader population than the patient population studied in controlled trials may be appropriate after careful consideration of the generalizability of the evidence, consistencies in the disease process across different groups, and the drug’s overall benefits and risks.” This is especially important for therapeutic areas in which the patient population is small, the disease is heterogeneous with highly diverse clinical manifestations, and reliable and validated endpoints that span the spectrum of the disease may not be established. BIO also believes that the examples of Indications and Usage, and the Limitations of Use statements, provided in the guidance are generally reasonable and clear.
Identification of Outcomes, Endpoints, and Benefit(s) the Drug Conveys
BIO suggests this section could be strengthened by including language around surrogate endpoints used to support accelerated approvals. Specifically, as more innovative products get approved in new therapeutic areas based on novel surrogate endpoints, it would be beneficial to include information and a description to support how the surrogate endpoint “is reasonably likely to predict a clinical benefit.” This will facilitate an appreciation of the effectiveness of such drug by those who are trying to interpret a label where approval was based on a novel surrogate endpoint for which they may have limited familiarity.
Download Full Comments Below
BIO Letter Indiaction And Usage Section Of Labeling-9-7-18
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BIO suggests this section could be strengthened by including language around surrogate endpoints used to support accelerated approvals. Specifically, as more innovative products get approved in new therapeutic areas based on novel surrogate endpoints, it would be beneficial to include information and a description to support how the surrogate endpoint “is reasonably likely to predict a clinical benefit.” This will facilitate an appreciation of the effectiveness of such drug by those who are trying to interpret a label where approval was based on a novel surrogate endpoint for which they may have limited familiarity.