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FDA pushes back generic drug labeling rule

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GPhA: Delay reflects widespread concerns about proposed change

WASHINGTON — The Food and Drug Administration is again postponing the release of a final rule that would change generic drug labeling requirements.

In a Federal Register notice this week, the FDA indicated that it aims to implement the final rule in April 2017, though many industry stakeholders had expected the agency to do so this spring. The move marks the third delay since the rule proposal was released in November 2013.

Titled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” the rule would allow generic drug manufacturers to make changes to their products’ labels, which they currently aren’t permitted to do unless the manufacturer of the reference listed drug first changes its label.

Chip Davis_PhRMA_GPhA copy

Chip Davis

The Generic Pharmaceutical Association (GPhA) said Thursday that the delay reflects the concerns raised by doctors, pharmacists, Congress, hospitals, health supply-chain stakeholders, generic and branded drug manufacturers, and others in the three years since the rule was introduced.

“GPhA is pleased that the FDA is again choosing to delay finalizing its proposed rule to change generic drug labeling requirements,” GPhA president and chief executive officer Chip Davis said in a statement. “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.”

GPhA noted that the FDA’s proposed rule would allow generics makers to update product labels without first getting the agency’s approval, which the association called “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, the FDA regulates the labeling process, and a generic drug is prohibited by law from having label content that differs from its branded counterpart. GPhA emphasized that such “sameness” in labeling information provides assurance to health providers that branded drugs and their generics have the same active ingredients, safety profile and efficacy.

Under the FDA’s rule proposal, a brand-name medication and its generic alternatives — on average numbering six to eight products, and sometimes up to 20 products — could have different and possibly conflicting safety information, GPhA pointed out. The association cited estimates by Matrix Global Advisors that the rule would hike costs for patients, payers and public programs by at least $4 billion a year.

“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,” Davis added. “In short, changing our system to allow inconsistent labels for scientifically equivalent products is a risky proposition for patients and the health care system.”

In March 2014, 22 health industry organizations signed a letter to the FDA that urged the agency to re-examine its proposed rule on pharmaceutical labeling. Companies and organizations signing the letter included Walgreens, CVS Caremark, Rite Aid, Walmart and the National Association of Chain Drug Stores as well as McKesson, Cardinal Health, AmerisourceBergen, H.D. Smith, the American Pharmacists Association, the Healthcare Distribution Management Association, the Healthcare Supply Chain Association, Express Scripts, the Pharmaceutical Care Management Association, the Academy of Managed Care Pharmacy, the American Association of Colleges of Pharmacy, the American Society of Health-System Pharmacists, Amerinet, the Cardiovascular Research Foundation, Innovatix, MedAssets, the National Coalition on Health Care, Novation and the Premier Healthcare Alliance.

GPhA said Thursday that it supports replacing the proposed FDA rule with the Expedited Agency Review (EAR), a generic and branded drug industry-supported meansure that would bolster and expedites the communication of drug safety information. The association noted that the EAR would meet the FDA’s objectives of its proposed rule without the associated safety risks or costs to the health care system.


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