MANY of you have written me asking what to do now that the FDA Ombudsman is telling you to “file a Petition”. However, in order to do that you will need VOLUMES of supporting documents (which the normal, PD and RLS patient do NOT have!).
So, let’s try to get through the maze of FDA bureaucracy another way:
Go to this site and fill in the blanks to file a complaint about the “Complete Response Letter” from the FDA’s Center for Drug Evaluation and Research to UCB SA.
Be SURE to use this URL to reference the letter that was sent to UCB SA telling them to “reformulate the Neupro” patch.
Folks, we don’t have to sit back and WAIT another two years while the FDA plays their political games helping “the competitor drug company” get a leg up over UCB (just because they aren’t an American company). We need to be vocal, active participants in drawing attention to this farce of the FDA “trying” to protect us from the Neupro patch. They know, and WE know that the FDA exists for our safety and protection? The Neupro patch is safe AND effective in its’ present state.
Don’t sit quietly and suffer – just click on the link and tell the CDER that they need to reconsider their ruling NOW!