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Statement by Ralph G. Neas, President and CEO, GPhA, Regarding the FDA Public Meeting on Generic Drug Labeling

Contact: Steve Arnoff 202.249.7113


WASHINGTON, DC (March 27, 2015) –
“The Generic Pharmaceutical Association (GPhA) 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. 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.

A better approach is the Expedited Agency Review (EAR), an alternative proposal supported by both GPhA and the Pharmaceutical Research and Manufacturers of America (PhRMA) — as well as additional healthcare stakeholders — 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.

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 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. 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.”

* “New safety information” has the definition provided in the Guidance for Industry: Safety Labeling Changes – Implementation of Section 505(o)(4) of the FD&C Act, dated July 2013.

GPhA Labeling Comments
Supply Chain letter
Minority Group letter (1)
Minority Group letter (2)
Patients/Veterans letter

About GPhA

GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at Follow us on twitter: @gpha