Monday, December 7, 2015

Press Release: FDA Delay in Safety Rule Leaves Patients at Risk

FDA Delay in Safety Rule Leaves Patients at Risk

Completion Date for Generic Labeling delayed until July 2016

CHARLOTTE, N.C., Dec. 7, 2015 /PRNewswire-iReach/ -- The Food and Drug Administration (FDA) has postponed for a second time a decision on whether to close an important drug safety loophole, leaving millions of patients who rely on generic medications at serious risk.

Currently, patients who are harmed by a generic drug cannot sue the manufacturer. Even more distressing, manufacturers of generic drugs are not required to update the patient warning labels like manufacturers of brand name drugs are.

The FDA has not yet finalized a proposed labeling rule and has several times delayed its expected completion date. Originally scheduled for September, it was delayed until February 2016. However, in its regulatory agenda, released in November, the FDA has now pushed back the date even further to July 2016.

The FDA's proposed rule is in response to a Citizen Petition filed by consumer safety advocacy group Public Citizen. On March 27, 2015 the FDA held a Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products hearing in White Oak, Maryland.
Rachel Brummert, executive director of the Quinolone Vigilance Foundation, testified on behalf of herself and other patients who took a generic fluoroquinolone antibiotic such as levofloxacin, ciprofloxacin, moxifloxacin and others, and were disabled by them. She urged the FDA to take action and close the generic drug loophole.

"Patients who are hurt by generic drugs should have the same rights as those who are injured by brand name versions of the same medications. Lives could be saved and injuries prevented if all prescription medications carried up-to-date and adequate warning labels. Finalizing the proposed rule by the FDA will promote safety by holding generic drug manufacturers accountable and would speed the dissemination of safety information to doctors and patients. A delay in finalizing the proposed rule will only lead to more patients being hurt", says Ms. Brummert.

Unfortunately, the delay has happened a second time, leaving Brummert gravely concerned. "More patients have been hurt, and will continue to be hurt, by generic medications due to this delay".
The generic drug loophole has gained the attention of United States Senator Al Franken, who asked FDA Commissioner nominee Dr. Robert Califf during a recent Senate hearing about the current plan to finalize the labeling rule.

Rachel Brummert, and other victims who were harmed by generic medications, are grateful that others are taking notice of this important proposed rule. "Generic drugs account for more than 80 percent of prescriptions in the United States, and under current guidelines, patients are at serious risk. The Quinolone Vigilance Foundation urges the FDA to close the generic loophole promptly and to end the delays to ensure that patients have access to updated safety information in a timely manner", affirms Brummert.

About The Quinolone Vigilance Foundation

The Quinolone Vigilance Foundation (QVF) is a non-profit, charitable foundation that helps raise awareness about fluoroquinolone antibiotics and their dangers among patients and medical professionals, and funds research on fluoroquinolone toxicity.
Media Contact: Rachel Brummert, Quinolone Vigilance Foundation, 609-575-9839,


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