Congress Must Hold FDA Accountable to Its Public Health & Safety Mission on Generic Drug Labeling, Says GPhA

Published Online: Tuesday, April 1, 2014
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WASHINGTON, DC (April 1, 2014) — Today, Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association (GPhA), testified before the House Energy and Commerce Subcommittee on Health. In his testimony, Neas urged Congress to continue to require that the Food and Drug Administration (FDA) meet its public health and safety obligations on generic drug labeling through timely review of all available clinical data, including the proprietary data of the brand company, prior to label changes. Neas also called on Congress to ensure that the FDA has the resources it needs to accomplish this objective.

“When it comes to safety decisions about prescription drugs, American consumers deserve, and are entitled to, the benefit of the scientific and public health expertise of the FDA. That is why more than 60 organizations filed comments or signed letters to the FDA, logging serious concerns with the proposed rule as drafted. This includes more than 20 patient advocacy, disability, minority and veterans groups, 24 stakeholders across the healthcare supply chain, and leading governmental, legal and economic voices. These groups recognize that the proposed rule would create major problems by allowing for generic manufacturers to make changes to safety labels without prior FDA approval,” said Neas.

According to Neas’ testimony:

“A key element of any new system must include timely FDA review of all available clinical data and safety signals, including the non-public data of the [new drug application] NDA holder. Underlying this process should be one bedrock principle: that generic drug labels must be FDA-approved and must be based on scientific evidence. Such a system would advance our shared goals of protecting the public health and improving patient safety. Congress should ensure that the FDA has sufficient resources to do so.”

“The sustainability of our health care system depends on the continued access to affordable generic medicines. We will continue to work to make sure that any changes to labeling rules and regulations protect patient safety, align with federal laws, and do not hinder patient access to more affordable generic medicines,” Neas concluded.

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GPhA Comments Submitted to FDA on the Proposed Rule
Patient Advocates Letter
Minority Organizations Letter
Los Angeles Times Editorial
Matrix Global Advisors (MGA) report: FDA’s Proposed Generic Drug Labeling Rule: An Economic Assessment
The Hill Op-Ed
Infographic: FDA Proposed Rule Would Cause Dangerous Confusion, Economic Side Effects
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