GPhA Supports Alternative to FDA's Generic Drug Labeling Rule

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-11-2015 15:28


The Generic Pharmaceutical Association (GPhA) issued its support of public meeting held by the US Food and Drug Administration in response to comments from healthcare stakeholders, legislative membership organizations, supply-chain participants, and others with concern about the FDA's proposed rule on generic drug labeling that would allow generic companies to update labels without prior FDA approval.

Instead of the proposed rule, GPhA said it, the Pharmaceutical Research and Manufacturers of America (PhRMA), and additional healthcare stakeholders support an alternative, the Expedited Agency Review (EAR), which GPhA said meets the FDA's goal to strengthen and expedite the labeling process but does so "without provisions that could have unintended safety consequences for patients, providers, taxpayers, payors or others," said GPhA in a statement.

The EAR would establish defined time parameters for the FDA to take action on a label change made: (1) following the FDA’s receipt and review of “new safety information” (as defined in Guidance for Industry: Safety Labeling Changes–Implementation of Section 505(o)(4) of the FD&C Act, dated July 2013) from a multi-source application holder; or (2) following review of data received through the Sentinel System and/or other databases, including global sources that are suggestive of a need for a label change. Moreover, the EAR calls for the adoption of e-labeling technology to make new information available in real time.

GPhA says the proposed rule relies on updates to paper labels that can take months or even years to be incorporated. GPhA said that Tte EAR reinforces the basic goals set forth in the FDA proposal by: (1) assuring that all application holders meet their responsibility of reporting safety related information; and (2) making newly evaluated safety information available to practitioners and the public as soon as possible.

"It is important that any final rule ensures patient and practitioner access to consistent, science-based information to best inform treatment decisions. Patient safety is both the Agency’s mission and expertise," said GPhA in a statement. "The Proposed Rule’s intent to address liability is the sole purview of Congress and exceeds the Agency’s authority. The generic pharmaceutical industry will continue to work with the FDA and other stakeholders to make sure that drug labels protect patient safety, align with federal laws, and do not hinder patient access to more affordable generic medicines.”

Source: Generic Pharmaceutical Association


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