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.
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)--www.SaferPills.org-
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, rachel@saferpills.org
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