Psychiatric Citizen Petition
In a move echoing their response to the Citizens’ petition submitted by Dr.
Bennett and The Southern Network on Adverse Reactions (SONAR) on Mitochondrial Toxicity from June 2014, the FDA has also failed to act on the Citizen’s petition (Docket #FDA-2014-P-1611) submitted by Dr. Bennett and SONAR submitted in September of 2014. Read The FDA’s Response to the Psychiatric Petition Here.
Using the same wording, The FDA, in its response to the second petition about psychiatric issues, may require further review by the FDA since these are new issues we raised (even though they are based on the FDA’s own MedWatch data).
Mitochondrial Toxicity Citizen Petition
As you know, the mitochondrial toxicity Citizen’s petition (Docket #FDA-2014-P-0856) is based directly on the April 17, 2013 FDA report. The response to this petition sent December 2014 states the FDA would not take action at this time because the Citizen Petition requires “extensive review and analysis by Agency officials.” Since the petition is based on the FDA’s own words, from the FDA’s own research, outlined in the FDA’s own report, what the FDA is saying is that Agency officials have to review and analyze what the Agency officials themselves wrote. This is ridiculous.
Given (1) the seriousness of the issues in the mitochondrial toxicity petition (neurodegenerative diseases, including ALS, Alzheimer’s and Parkinson’s), (2) that it is based on the FDA’s own report, and (3) that the FDA has made public statements that it is aware of the petition, this petition deserves a real response, not some generic reply.
To say the petition “raises complex issues” is also ridiculous. The petition does not raise issues; it repeats information from the FDA’s own report. Read the FDA’s Response to the Mitochondrial Petition Here.
Take Action
What can you do? We must not let the FDA drop the ball and dismiss these legitimate serious concerns. For now we are asking everyone to email Dr. Margaret Hamburg, and her replacement Dr. Stephen Ostroff, at the following email addresses:
Dr. Margaret Hamburg – margaret.hamburg@fda.hhs.gov
Dr. Stephen Ostroff – stephen.ostroff@fda.hhs.gov
Let them know, in your own words, that the FDA’s response to these petitions is unacceptable and they need to take action on these serious threats to the health and safety of US Citizens.
Please stay tuned to MyQuinStory for updated reports on current news surrounding SONAR’s psychiatric petition.
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