The Generic Pharmaceutical Association applauds the House Appropriations Committee for approving the FY 2017 Agriculture Appropriations funding bill with provisions that would stop the Food and Drug Administration from using federal funds to finalize or implement its Proposed Rule to update generic drug labeling requirements as written.
WASHINGTON, DC (April 22, 2016) — The Generic Pharmaceutical Association (GPhA) applauds the House Appropriations Committee for approving the FY 2017 Agriculture Appropriations funding bill with provisions that would stop the Food and Drug Administration (FDA) from using federal funds to finalize or implement its Proposed Rule to update generic drug labeling requirements as written. GPhA appreciates the Committee’s longstanding interest in this proposed rule and its concerns regarding the proposal’s substance and process.
The FDA Proposed Rule would make generic manufacturers responsible for label information updates without prior FDA approval. GPhA strongly supports Section 747 of this funding bill, which specifies that in order to receive the necessary funding, the agency must first approve of a label change and also ensure an identical change is made to the reference (brand) product.
"GPhA is pleased that House appropriators recognize the need to avoid the vast unintended consequences that would arise should the FDA finalize this Proposed Rule as written,” said Chip Davis, President and CEO, Generic Pharmaceutical Association (GPhA). “Instead, GPhA continues to urge the FDA to consider the brand and generic drug industry supported Expedited Agency Review (EAR), a solution that accomplishes the FDA stated objectives without putting safety or savings at risk."
A wide range of concerns are shared by health stakeholders who agree that FDA should remain the central authority for label changes. These groups continue to caution FDA that the proposed rule could cause patient and provider confusion and hinder their ability to perform their jobs. Further, the FDA proposal could cost the health system more than $4 billion annually, according to Matrix Global Advisors.
“The Proposed Rule contradicts and undermines precedent set by the Drug Price Competition and Patent Term Restoration Act (The Hatch-Waxman Act), the foundation of the generic drug industry. Hatch-Waxman ensures that safe, effective and affordable medicines are accessible to patients and providers and requires that with FDA approval generics and their reference products have the same active ingredients and same labeling information,” said Davis.
“In addition to substantially driving up health costs, allowing a scenario where the same medicines could have conflicting label information would cause confusion and poses risks to patients. We look forward to continuing to work with Congress, the FDA and others to ensure that any changes made to the generic drug labeling process prioritize patient safety and avoid unraveling the regulatory fabric responsible for decades of patient access and trillions of dollars in patient and health system savings,” said Davis.