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GPhA/PhRMA Press Alternative to FDA Proposed Rule on Generic Drug Labeling

Contact: Steve Arnoff 202.249.7113

Supply Chain Groups, Minority Health Organizations Urge FDA to Adopt Expedited Agency Review

WASHINGTON, DC (April 27, 2015) — Today, the Generic Pharmaceutical Association (GPhA) submitted new comments on the Food and Drug Administration’s (FDA’s) Proposed Rule to update generic drug labeling requirements, urging the agency to adopt the joint alternative proposal known as the Expedited Agency Review (EAR), that it has put forward with the Pharmaceutical Research and Manufacturers of America (PhRMA).

Additionally, supply chain participants, minority health groups and others signed letters to the agency supporting the EAR and raising patient safety concerns with the Proposed Rule as drafted.

“GPhA shares the FDA goals to promote and protect public health,” said Ralph G. Neas, President and CEO, GPhA. “However, the Proposed Rule creates a scenario where disparate and potentially conflicting information from multiple manufacturers for single medicines could be widespread, causing confusion and putting patient safety, access and savings at risk.

The FDA is the only entity with all of the data needed to recommend a safety information change. No single manufacturer has access to the full range of available data — the proprietary data from clinical studies or the data held by each individual applicant holder. The proposed rule would require generic manufacturers to update labels based on incomplete information without first receiving FDA approval.”

For these reasons, 48 organizations that represent minority health providers, the nation’s pharmaceutical supply chain and others stand with GPhA and PhRMA in support of an alternative to the FDA proposed rule to change generic labeling guidelines – the EAR. The supply chain letter reads:

We believe that simple changes to the proposed rule can achieve all of FDA’s objectives related to efficient communication of important safety information… We fully support the science-based alternative called the Expedited Agency Review (EAR), which has the support of both generic and brand name drug manufacturers because it relies on the FDA to review new safety information for multi-source products and requires FDA to take action on a label change made on all multi-source products within a defined time period.

In addition to safety concerns, the cost burden of the proposed rule as written would be significant. A report by Matrix Global Advisors finds that spending on generic drugs could increase by $4 billion per year. Of this, government health programs could pay an additional $1.5 billion, and private health insurance, $2.5 billion for generic drugs.

Further, a survey co-released by GPhA and the National Coalition on Healthcare revealed that the healthcare providers patients rely on most to explain safety information about their prescription drugs — physicians, physician assistants, and pharmacists — are wary of the proposed rule causing patient confusion (76%). Further, these professionals believe that current safety information available is adequate (86%) and that FDA approval should be required before any label change is made (81%). Respondents also indicated that the proposed rule could impact their willingness to prescribe generic drugs (60%).

“The EAR meets the FDA stated objectives, defines time parameters for FDA action and endorses adoption of e-labeling technology to make new information available in real time rather than the months or years it takes to incorporate paper label changes,” said Neas. “Importantly, the EAR does all of this while assuring that multiple labels don’t exist for the same products. Patient safety is both the Agency’s mission and expertise. The proposed rule’s intent to address liability is the sole purview of Congress and exceeds the Agency’s authority.”

GPhA comments
Supply chain letter
Minority group letter

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 86 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending. Additional information is available at Follow us on twitter: @gpha.