CHARLOTTE, N.C., July 27, 2016 /PRNewswire-iReach/ -- On March 27, 2015 the U.S. Food and Drug Administration (FDA) held a hearing for a proposed rule that requires generic drug manufacturers to update their warning labels. Rachel Brummert, Executive Director of the Quinolone Vigilance Foundation, testified at the hearing on behalf of herself and countless other patients who took generic fluoroquinolone antibiotics and were later disabled. She urged the FDA to take action and close the generic drug loophole.
"While generic medications are an attractive alternative to expensive brand name drugs, the cost for patients can be much higher in the long term," says Brummert. "Many patients have been seriously injured, disabled and even killed by using generic drugs. Yet, generic drug makers are not required to update or have adequate warnings listed on their medications. And most importantly, patients that take generic drugs and suffer serious medical problems do not have the opportunity to take legal action against the manufacturers, unlike brand name drug manufacturers."
In 2011, the United States Supreme Court issued a landmark decision in Pliva v. Mensing that shielded generic drug makers from lawsuits regarding their labeling of adverse reactions on medications. As a result, only manufacturers of brand name drugs are required to update their warning labels if they learn of new risks or side effects from a drug. However, generic drug manufacturers are not.
"The FDA is responsible for protecting and promoting public health through the regulation and supervision of prescription medications, including generic medications," Brummert continues. "Delaying a decision on this matter is shirking their responsibility to protect patients. We have met with the FDA and Congress, but we have not made progress. We would like to work with government agencies to protect patients, not have to battle them."
In 2013, in response to a Citizens Petition filed by consumer watchdog group Public Citizen, the FDA announced the need to create a level playing field between generic and brand name drugs. This included changing its rules so generic drug manufacturers have the legal responsibility to update their warnings to patients and doctors.
A decision on this proposed rule from the FDA was scheduled for September 2015 and has been delayed three times. Now, the FDA has chosen not to issue a decision on the rule until 2017.
About The Quinolone Vigilance Foundation
The Quinolone Vigilance Foundation (QVF)--www.SaferPills.org- is an international non-profit, charitable foundation headquartered in Charlotte, North Carolina, whose mission is to build an international awareness movement by advocating for patients who are harmed by fluoroquinolone antibiotics, educating medical professionals, strengthening warning labels, reducing antibiotic resistance through the vigilant use of antibiotics, and funding research on fluoroquinolone toxicity.
Media Contact: Rachel Brummert, Quinolone Vigilance Foundation, 609-575-9839, email@example.com
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