The man from the FDA returned my call this morning.  He referred me to the department that works on Neurology products. If you wish to inquire about the status of the Neupro transdermal patch approval, you may call 301-796-2250.  There is a project manager there that is working with UCB but here are the names of the Director and Supervisory Project Manager:

Division of Neurology Products (DNP)

Director – Russell G. Katz, M.D. 301-796-2250

Deputy Director – Vacant

Supervisory Project Mngr. – Robbin Nighswander, R.Ph. 301-796-2250

 

 

 

Additionally, the process for the FDA to work with your doctor and UCB to get you the patches is clearly defined on the FDA website.  While I couldn’t find it yesterday, the gentleman who called me steered me to it.  Go to:  http://www.fda.gov/cder/cancer/singleIND.htm  Now I know it seems strange to go to the cancer portion of the FDA website, but he assurred me that the process was the same for a drug manufacturer and the FDA to consider a compassionate use drug plan for a patient – Parkinson’s or cancer – it doesn’t matter.

Within the form you will find a link to Form FDA 1571.  This is the form that must be completed by your doctor and submitted to FDA once your doctor has consent from UCB to extend the patches to you.  When your doctor submits the form it should go to mia.prather@fda.hhs.gov  Since she is the contact she can probably answer any questions about the process.