FDA's CDER Director Janet Woodcock Testifies Before Congress on Proposed Labeling Rule for Generic Drugs

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-03-2014 09:40


Janet Woodcock, Director of FDA's Center for Drug Evaluation and Research, testified before the Subcommittee on Health, Committee on Energy and Commerce of the US House of Representatives on April 1, 2014, to discuss FDA's proposed labeling rule for generic drugs. As outlined by Woodcock the rule, if finalized, would speed the dissemination of new safety information about generic drugs to health professionals and patients by allowing generic drug makers to use the same process as brand drug manufacturers to update safety information in the drug product labeling. FDA closed public comment on the proposed rule on March 13, 2014 and is considering those comments as it develops a final rule.

On November 13, 2013, FDA issued a proposed rule to amend its regulations to revise and clarify procedures for application holders to change the labeling of an approved drug or biological product to reflect certain types of newly acquired information in advance of FDA’s review of the change through a “changes being effected” (CBE-0) supplement  The proposed rule would create parity among application holders, with respect to these safety-related labeling changes, by permitting generic drug application holders (abbreviated new drug application (ANDA) holders) to distribute revised generic drug labeling that describes newly acquired safety-related information and, thus, may differ in certain respects, on a temporary basis, from the corresponding brand drug (the reference listed drug (RLD)) labeling at the time that the generic drug application holder submits a CBE-0 supplement to FDA. "The proposed rule recognizes the obligation of all drug application holders to monitor safety information about the drugs they market and ensure that product labeling is accurate and up to date, and proposes a pathway to ensure that all drug application holders can fulfill that obligation and communicate important new safety information to prescribers and consumers,"
said Woodcock.  

"In the current marketplace, in which approximately 80% of drugs dispensed are generic, and brand drug manufacturers may discontinue marketing after generic drug entry, FDA believes it is time to provide generic drug application holders with the means to update product labeling to reflect data obtained through post-marketing surveillance, even though this will result in temporary labeling differences among products," said Woodcock in her testimony.  "This proposed rule reflects the Agency's judgment that concerns related to temporary differences in labeling between generic drugs and their corresponding brand drugs are outweighed by the benefit to the public health, which would result from all application holders having the ability to independently update drug product labeling to reflect newly acquired information regarding important drug safety issues through CBE-0 labeling supplements."

Woodcock further specified that if approval of the application for the corresponding brand drug has been withdrawn (for reasons other than safety or effectiveness), FDA’s evaluation of the labeling change proposed by the generic drug application holder would consider any submissions related to the proposed labeling change from any other application holder, for drug products containing the same active ingredient. The proposed rule would create that pathway for the generic drug application holder to help ensure that safety information reaches prescribers and consumers in a timely way.

She also specified that when safety-related labeling updates are implemented through the CBE-0 supplement process, there may be temporary differences in drug labeling. This currently occurs when branded drug application holders update their product labelings through the CBE-0 process, and the generic drug application holders must wait until FDA approves the change to the brand drug labeling to update generic drug labeling. "Under the proposed rule, generic drug application holders would have the same ability as brand drug application holders to update product labelings with newly acquired safety-related information and FDA would reach a decision regarding the approvability of the labeling proposed by the generic and brand drug application holders regarding the safety issue at the same time." she said.

To enhance transparency and make the safety-related changes to drug labeling described in a CBE-0 supplement readily available to prescribing health care providers and the public while FDA is reviewing the supplement, FDA proposes to establish a dedicated Web page (or, alternatively, to modify an existing FDA Web page) on which FDA would promptly post information regarding the labeling changes proposed in a CBE-0 supplement.

Source: FDA











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