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Food and Drug Administration, Health and Human Services (HHS).
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Geriatric Information in Human Prescription Drug and Biological Product Labeling.” This draft guidance is intended to assist applicants of human prescription drug and biological products in determining the appropriate placement and content of geriatric information in labeling. The goal of this draft guidance is to provide recommendations to help ensure that appropriate information on the use of prescription drugs and biological products in geriatric patients is consistently placed in the proper sections and subsections within labeling so that the information is clear and accessible to health care practitioners and includes content that guides the safe and effective use in geriatric patients. This draft guidance provides additional examples of geriatric use statements in labeling and examples of when the labeling regulations authorize FDA to permit applicants to omit or revise specific information otherwise required in the Geriatric Use subsection. We are withdrawing the guidance for industry entitled “Content and Format for Geriatric Labeling” (October 2001) and replacing it with this draft guidance.
Submit either electronic or written comments on the draft guidance by November 16, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
You may submit comments on any guidance at any time as follows:
Submit electronic comments in the following way:
Submit written/paper submissions as follows:
Instructions: All submissions received must include the Docket No. FDA-2020-D-1621 for “Geriatric Information in Human Prescription Drug and Biological Product Labeling.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.
Eric Brodsky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6485, Silver Spring, MD 20993-0002, 301-796-0855; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
FDA is announcing the availability of a draft guidance for industry entitled “Geriatric Information in Human Prescription Drug and Biological Product Labeling.”
Until the late 1990s, the majority of drug labeling contained minimal or no geriatric use information to guide safe and effective use in the geriatric population. In 1997, the FDA issued a final rule creating a Geriatric Use subsection of labeling to facilitate access to geriatric use information and improve the safe and effective use of prescription drugs and biological products in geriatric patients by specifying a location for summarizing geriatric use information in labeling (62 FR 45313, August 27, 1997). This regulation was intended to promote the consistent inclusion of all relevant geriatric information in labeling and to provide information on possible differences in the safety, effectiveness, pharmacodynamics, and/or pharmacokinetics between geriatric and younger adult patients in labeling.
In 2001, the FDA issued the now-withdrawn guidance for industry entitled “Content and Format for Geriatric Labeling,” which provided recommendations on the content and format of geriatric use information in the Geriatric Use subsection in the PRECAUTIONS section. In 2006, FDA published a final rule amending the requirements for the content and format of labeling for human prescription drug and biological products (71 FR 3922, January 24, 2006). This rule is known as the physician labeling rule because it addresses prescription drug labeling that is used by physicians and other health care practitioners. Under this rule, the Geriatric Use subsection was relocated in the USE IN SPECIFIC POPULATIONS section of labeling.
This draft guidance replaces the withdrawn guidance for industry entitled “Content and Format for Geriatric Labeling” and provides additional examples of geriatric use statements in labeling and examples of when the regulations authorize FDA to permit applicants to omit or revise specific information otherwise required in the Geriatric Use subsection.
This draft guidance provides recommendations on how to incorporate geriatric use information in labeling based on the following two scenarios:
The Geriatric Use subsection of labeling regulations (21 CFR 201.57(c)(9)(v)) uses a variety of terms to refer to patients 65 years of age and older ( e.g., geriatric patients, elderly patients, persons 65 years of age and older). Some terms may be sensitive or controversial among certain groups. Please comment and provide a rationale for the use of any of these terms or other terms to refer to patients 65 years of age and older in labeling.
This draft guidance provides several recommended options for summarizing geriatric exposure information in the Geriatric Use subsection. Please comment and provide a rationale for the use of any of these geriatric exposure examples or other geriatric exposure examples. Please describe when binning, nested cutoff, or other approaches should be used to summarize geriatric exposure information in this subsection.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA ( printed page 57866) on the “Geriatric Information in Human Prescription Drug and Biological Product Labeling.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collection of information in 21 CFR 201.56 and 201.57 for preparing and submitting labeling has been approved under OMB control number 0910-0572.
Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.
Dated: September 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20435 Filed 9-15-20; 8:45 am]
BILLING CODE 4164-01-P
15 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.