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HHS/FDA RIN: 0910-AG94 Publication ID: Fall 2015 
Title: Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 

This rule would amend the regulations regarding new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics license applications (BLAs) to revise and clarify procedures for changes to the labeling of an approved drug to reflect certain types of newly acquired information in advance of FDA's review of such change.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 314.70    21 CFR 314.97    21 CFR 314.150    21 CFR 601.12   
Legal Authority: 21 U.S.C. 321    21 U.S.C. 331    21 U.S.C. 352    21 U.S.C. 353    21 U.S.C. 355    21 U.S.C. 371    42 U.S.C. 262    ...   
Legal Deadline:  None

Statement of Need:

In the current marketplace, approximately 80 percent of drugs dispensed are generic drugs approved in ANDAs. ANDA holders, like NDA holders and BLA holders, are required to promptly review all adverse drug experience information obtained or otherwise received, and comply with applicable reporting and recordkeeping requirements. However, under current FDA regulations, ANDA holders are not permitted to use the changes being effected (CBE) supplement process in the same manner as NDA holders and BLA holders to independently update product labeling with certain newly acquired safety information. This regulatory difference recently has been determined to mean that an individual can bring a product liability action for "failure to warn" against an NDA holder, but generally not an ANDA holder. This may alter the incentives for generic drug manufacturers to comply with current requirements to conduct robust postmarketing surveillance, evaluation, and reporting, and to ensure that their product labeling is accurate and up-to-date. Accordingly, there is a need for ANDA holders to be able to independently update product labeling to reflect certain newly acquired safety information as part of the ANDA holder's independent responsibility to ensure that its product labeling is accurate and up-to-date.

Summary of the Legal Basis:

The Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the Public Health Service Act (42 U.S.C. 201 et seq.) provide FDA with authority over the labeling for drugs and biological products, and authorize the Agency to enact regulations to facilitate FDA's review and approval of applications regarding the labeling for those products. FDA's authority to extend the CBE supplement process for certain safety-related labeling changes to ANDA holders arises from the same authority under which FDA's regulations relating to NDA holders and BLA holders were issued.


FDA is considering several alternatives described in comments submitted to the public docket established for the proposed rule.

Anticipated Costs and Benefits:

FDA is reviewing comments submitted to the public docket and evaluating the anticipated costs and benefits that would be associated with a final rule.


This rule is intended to remove obstacles to the prompt communication of safety-related labeling changes that meet the regulatory criteria for a CBE supplement. The rule may encourage generic drug companies to participate more actively with FDA in ensuring the timeliness, accuracy, and completeness of drug safety labeling in accordance with current regulatory requirements. FDA's posting of information on its website regarding the safety-related labeling changes proposed in pending CBE supplements would enhance transparency, and facilitate access by health care providers and the public so that such information may be used to inform treatment decisions.

Action Date FR Cite
NPRM  11/13/2013  78 FR 67985   
NPRM Comment Period Extended  12/27/2013  78 FR 78796   
NPRM Comment Period End  01/13/2014 
NPRM Comment Period Extended End  03/13/2014 
NPRM Comment Period Reopened  02/18/2015  80 FR 8577   
NPRM Comment Period Reopened End  04/27/2015 
Final Rule  07/00/2016 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: Yes 
Agency Contact:
Janice L. Weiner
Principal Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 51, Room 6270,
Silver Spring, MD 20993-0002
Phone:301 796-3475
Fax:301 847-8440