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Walmart Raises Patient Safety and Patient Savings Concerns on Proposed Generic Labeling Rule


Steve Arnoff


Retailer Joins Rite Aid, Other Groups Calling on FDA to Examine Unintended Consequences for Consumers, Health Care System

WASHINGTON, DC (March 12, 2014) – Retail giant Walmart, one of the world’s largest employers and where millions of Americans fill their prescriptions each year, has joined almost two dozen organizations from across the healthcare supply chain in a letter calling on the FDA to consider the public health impact of its Proposed Rule on pharmaceutical labeling. Walmart, along with Rite Aid – the third-largest drug store chain in America – is the latest stakeholder to agree that the Proposed Rule raises serious questions about patient safety, cost and access.

“Walmart was a pioneer in promoting safe, affordable generic medicines for consumers and their families through its ground-breaking $4.00 generics program and continues to be a leader in ensuring access to life-saving medicines,” said Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association (GPhA). “Today they lend their voice to a chorus of healthcare companies concerned that the Proposed Rule creates a regulatory framework whereby multiple, different labeling, including different warnings, can simultaneously exist in the marketplace for multiple generic versions of a drug. This would cause dangerous confusion, increase costs, and reduce availability of generic medicines for patients who need them most.”

Walmart and Rite Aid add their names to a letter signed by 22 health industry groups and submitted to the FDA, raising concerns about the proposed regulation. The signatories call for FDA to “fully explore the potential unintended consequences that the rule may have on patient access and national health care costs. Permitting labeling changes for generic drugs without FDA approval counters 30 years of law requiring generic and brand medicines to have the same labels.”

The letter also pointed to the impact of the Proposed Rule on healthcare system costs, citing a recent study by Matrix Global Advisors. It showed that spending on generic drugs would increase by $4 billion per year (or 5.4 percent of generic retail prescription drug spending in 2012). Of this, government health programs would pay $1.5 billion, and private health insurance, $2.5 billion.

To read the letter, click here.

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 84 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending, saving the health system nearly $200 billion annually. Additional information is available at Follow us on twitter: @gpha.