Executive Director Rachel Brummert to Testify at FDA Hearing

HAMILTON, N.J., March 24, 2015  — When Rachel Brummert went to her doctor for a suspected sinus infection, he wrote a prescription for Levaquin, a powerful antibiotic, which she assumed was safe. She was later prescribed levofloxacin for a bone infection. At the pharmacy, she was given the generic version of the drug because her insurance would not pay for the brand name, Levaquin. It was too expensive. Rachel didn’t mind. The generic was equivalent to the brand name drug, and it was cheaper.

Unfortunately, Rachel suffered a severe and disabling reaction to Levaquin and levofloxacin. That is when she discovered a hidden cost to generics. Patients who are harmed by a generic drug cannot sue the manufacturer of the drug. Even more shocking, manufacturers of generic drugs are not required to update the patient guides or warning labels. The drug she assumed was safe and inexpensive was, in fact, neither. Although Rachel has suffered through nine tendon ruptures, peripheral neuropathy, chronic gastric problems, and was diagnosed with a serious neurodegenerative disorder, all directly related to her use of these drugs, she has virtually no legal recourse.

All of that may change thanks to Rachel and others like her. On March 27, 2015, Quinolone Vigilance Foundation Executive Director Rachel Brummert will testify before the FDA at the Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products hearing in White Oak, Maryland. She hopes that by sharing her story, and the stories of other victims, the FDA will finally take action and close this generic drug safety legal loophole. “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 for the damage their products cause. A delay in finalizing the proposed rule will only lead to more patients being hurt”, says Ms. Brummert.

The Quinolone Vigilance Foundation (www.SaferPills.org) is a non-profit, charitable organization that fosters, initiates, and funds research on Fluoroquinolone Toxicity. We also advocate for injured and disabled patients who took a fluoroquinolone, and we educate patients and doctors so they can make an informed decision about their health.

Media Contact: Rachel Brummert, Quinolone Vigilance Foundation, 609-575-9839, rachel@saferpills.org