The Food and Drug Administration (FDA) is a large bureaucratic agency. Because of this, it is very important that we keep calculated, accurate pressure on the FDA in our quest to get mitochondrial toxicity warnings placed on Fluoroquinolone (FQ) labels.
As we mentioned before, on April 23th, 2015, a group from within the FQ community, consisting of Terry Aston, John Fratti, Linda Martin, David Melvin, and Alan Redd, held a conference with officials from the FDA to push for mitochondrial warnings to be placed on FQ labels.
A vital next step took place on June 10th, 2015. Dr. Charles Bennett, Terry Aston, and Linda Martin, met with Senate Staffers at the Dirksen Senate Building in Washington, D.C. to ensure pressure is maintained on the FDA.
An integrated report developed by Dr. Bennett, Terry Aston, John Fratti, Linda Martin, David Melvin, and Alan Redd was presented to the Senate staff. This report included data from our first meeting with the FDA in addition to very poignant highlights stressed by Dr. Bennett. At this meeting Dr. Bennett and the others,
- Highlighted and confirmed the current adverse event data maintained by the FDA
- Included adverse event data on Cipro in addition to the data already presented on Levaquin
- Highlighted the top 50 adverse events reported by patients for both Levaquin and Cipro
- Discussed how the FDA’s bar, for when it acts to place warnings, is set too high for the FQ’s.
- Reiterated the importance of the FDA acting on the Citizen Petitions presented by SONAR.
- Reiterated the FDAs legal responsibility to act in the best interest of public safety.
- Stressed the deaths and other serious events that have occurred while the FDA fails to act on the petitions.
Since our legislature provides oversight for the FDA, this meeting with senate staff had two overarching goals:
- It ensures that those who oversee the FDA have the same up-to-date accurate data regarding the FQs, and
- To ensure that the FDA is proceeding with the necessary internal steps to place the appropriate warnings on the FQs.
Senate staffers also reiterated that the nationwide media stories have been integrally important for bringing this issue to their attention as well.
The senate staff was encouraged to stay on top of the FDA internal process regarding the FQ’s, to encourage the FDA to work in conjunction with the Fluoroquinolone community, and to act on the Citizen’s Petitions submitted to the FDA by Dr. Charles Bennett and SONAR. As with the meeting with the FDA, the significant number of lives that could be saved by acting immediately was stressed several times throughout the meeting.
Like the nationwide media, and the FDA, the senate staff was encouraged to monitor the website www.fluoroquinolonestories.com for additional personal FQ stories, so it is vitally important to share your story on this website if you have not done so.
We believe that our April 23th, 2015 conference with FDA, which was under-girded by all the media stories to date and the personal stories of individuals affected by FQ’s, offers the best hope for action by the FDA on FQs to date.
Our interaction with senate staff, as well as our call to action to the FDA, is now part of the official government record. We will stay on top of the process and watch for the FDA’s response. We will continue to identify areas where we can insure consistent attention and pressure be brought to bear on this extremely important issue with the FDA.
Stayed tuned to My Quin story for timely updates on our interactions with the FDA, Dr. Bennett and the Citizen Petition, and community related research.