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Letter from Congressmen Israel and Bishop Raises More Questions About “Harmful” FDA Proposed Labeling Rule

Steve Arnoff


WASHINGTON DC, (September 23, 2014) — A letter released today by Congressman Steve Israel (D- NY) and Congressman Timothy Bishop (D-NY) raises serious concerns about the Food and Drug Administration (FDA) proposed rule on generic drug labeling currently under consideration at the agency, calling it “problematic” and “harmful.” The letter enumerates multiple concerns about the impact of the proposed rule, including the labeling safety decisions being made without access to complete safety data, health provider confusion, and the potential negative impact on use of generic medicines.

“In this letter, Representative Israel and Representative Bishop make a critical point: the proposed rule would create major problems by allowing for generic manufacturers to make changes to safety labels without prior FDA approval,” said Ralph G. Neas, President of the Generic Pharmaceutical Association (GPhA.) “In highlighting problematic provisions in this proposed regulation, these Congressmen join more than 60 organizations that filed comments or signed letters to the FDA, logging concerns with the proposed rule as drafted. This includes more than 20 patient advocacy, disability, minority and veterans groups, 24 stakeholders across the healthcare supply chain, and leading governmental, legal and economic voices.”

The letter, addressed to both the FDA and the Office of Information and Regulatory Affairs, comes at a time when FDA is considering more than 100 total responses to its controversial proposed rule, “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products,” which would dramatically alter the current regulations to allow generic medicine manufacturers to change their safety labels.

In the letter, the Congressmen echo the sentiment expressed by many others: namely, that the FDA alone has the authority and access to the complete data to update the labels of generic medicines.

It states: “Importantly, generic manufacturers already report adverse events to the FDA. The FDA could mandate a label change to both the brand and generic labels at any point. In fact, it is only the FDA that has complete adverse information on a particular drug from all manufacturers. Of great concern is the portion of the proposed rule which has the generic manufacturer update its label immediately while the FDA studies the change, but before the FDA makes a decision.”

The Congressmen go on to say that this sentiment is shared by many on the front lines of patient care, noting, “Recent survey results indicate that health care providers and pharmacists are concerned about the impact of the proposed rule on patients and patient care. According to the survey, three out of four respondents said patients would be confused by multiple labels for the same medicine. A significant majority (81%) of health care professionals responding to the survey said that FDA approval should be required before drug safety labels are changed.”

Neas summed up the problems with the proposed rule, saying, “As written, the rule is bad policy, bad for public safety and bad for public health,” he said. “Further, it could have negative consequences for the nation’s budget. An analysis by economic consulting firm Matrix Global Advisors (MGA) found that the proposed rule would add $4 billion dollars annually to the nation’s already high health care costs, undercutting the cost savings that generic medicines have brought to America’s patients and health care system. FDA policy on generic drug labeling must meet the agency’s public health and safety obligations through timely review of all available clinical data, including the proprietary data of the brand company, prior to label changes.”


Rep. Steve Israel and Rep. Tim Bishop letter to FDA on generic drug labeling
Fairleigh Dickinson University's PublicMind: Healthcare Professionals' Perspectives: FDA Proposed Rule on Generic Drug Labeling
Infographic: Healthcare Professionals' Perspectives: FDA Proposed Rule on Generic Drug Labeling
Patient Advocates letter to FDA
Minority organizations letter to FDA
Health Stakeholder organizations letter to FDA
Matrix Global Advisors Study

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.