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GPhA Applauds FDA Move to Delay Finalizing Proposed Generic Drug Labeling Rule

Contact: Steve Arnoff 202.249.7113 

WASHINGTON DC (May 19, 2016) — On Wednesday, the Food and Drug Administration (FDA) announced it would further delay finalizing its Proposed Rule to change generic drug label requirements. This marks the third such delay and reflects widespread recognition of public health concerns impacting patients and providers raised repeatedly by physicians, pharmacists, Congress, hospitals, health supply chain stakeholders, generic and brand drug manufacturers, and others in the three years since its introduction.

“The Generic Pharmaceutical Association (GPhA) is pleased that the FDA is again choosing to delay finalizing its Proposed Rule to change generic drug labeling requirements,” said Chip Davis, President and CEO, GPhA. “The FDA clearly appreciates the strong concerns articulated by a majority of health care experts, particularly those closest to patient prescribing. As drafted, the FDA Proposed Rule opens the door to avoidable public health risks and carries significant cost consequences that would reverberate through our health system.”

The FDA Proposed Rule calls for generic manufacturers to update product labels without first securing FDA approval — a drastic departure from 30 years of legal precedent created by Congress under the Hatch-Waxman legislation, supported by science and confirmed by the Supreme Court. Currently, FDA oversees the labeling process and a generic drug is prohibited by law from having label content that differs from its branded counterpart.

This “sameness” requirement assures health providers that brands and generics have the same active ingredients, safety profile and efficacy — all which has been conveyed through consistent label information. The Proposed Rule creates a scenario where a brand drug and each of its generic alternatives, on average 6-8 products, and sometimes up to 20 products, could have different and potentially conflicting safety information.

“The Proposed Rule undermines the principles that establish the foundation of a generic drug industry responsible for 88% of prescriptions dispensed in the United States but less than one third of total drug spending, which translates to hundreds of billions of dollars in annual savings,” said Davis. “In short, changing our system to allow inconsistent labels for scientifically equivalent products is a risky proposition for patients and the health care system.”

Matrix Global Advisors estimates this rule would increase costs by at least $4 billion annually for patients, payors and public programs.

GPhA supports replacing the Proposed Rule with the Expedited Agency Review (EAR), a generic and brand drug industry supported alternative that strengthens and expedites the communication of drug safety information. EAR accomplishes the FDA objectives of the Proposed Rule without the associated safety risks or costs to the healthcare system.

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 88 percent of the prescriptions dispensed in the U.S. but consume just 28 percent of the total drug spending. Additional information is available at Follow us on twitter: @gpha.