FDA revisits label changes with public meeting


SILVER SPRING, Md. — The Food and Drug Administration on Friday is hosting a public meeting on supplemental applications proposing labeling changes for approved drugs and biological products, the agency noted. The purpose of the meeting is to provide a public forum for the FDA to listen to comments on the proposed rule on “changes being effected” supplements that was published in the Federal Register of Nov. 13, 2013, and alternatives offered to this proposed rule.


"The Generic Pharmaceutical Association applauds the FDA for today's public meeting in response to comments from dozens of health care stakeholders, minority providers and legislative membership organizations, supply chain participants, and many others troubled about the FDA Proposed Rule on generic drug labeling," said Ralph Neas, GPhA president and CEO. "These groups continue to voice concerns about how the Proposed Rule would allow generic companies to unilaterally update labels without prior FDA approval, elevating patient safety risk, raising costs and causing confusion among prescribers and providers."


GPhA advocates the Expedited Agency Review, an alternative proposal that's also supported by the Pharmaceutical Research and Manufacturers of America that meets the FDA objective 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.


"The EAR would establish defined time parameters for FDA to take action on a label change made:

1) following FDA’s receipt and review of 'new safety information' 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," Neas said. "Moreover, the EAR calls for the adoption of e-labeling technology to make new information available in real time. The Proposed Rule relies on updates to paper labels that can take months or even years to be incorporated."


The FDA is also reopening the comment period for the proposed rule until April 27, 2015, to receive submissions of additional written comments on the proposed rule as well as alternative proposals presented during the public meeting.


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