NIH Pharmacy Development Section Issue – NOT applicable to NPC trials – Notes Dr. Porter of NIH
Dear NNPDF Families and Friends,
This afternoon a press release from the National Institutes of Health (NIH) outlined the discovery of a serious manufacturing problems and lack of compliance with standard operating procedures discovered during a recent at the NIH Pharmacy Development Section which the FDA inspected in late May 2015. We have received the following comments from Dr. Forbes Porter as it relates to the two Niemann-Pick Disease Type C (NPC) clinical trials which are currently being conducted at the NIH.
From: Dr. Forbes Porter
RE: NIH Pharmacy Development Press Release
Dated: Thursday, June 4th, 2015
I would like to notify you of an issue that has occurred in the NIH Pharmacy Development Section that is likely to hit the news. Please see below. I am concerned that there may be some confusion with respect to an investigational drug manufactured by the Pharmacy Development Section (PDS) and an investigational drug dispensed by the NIH pharmacy.
This does not affect either the cyclodextrin or vorinostat studies.
We are currently in the process of trying to notify the families that are participating in our trials. Please feel free to post or distribute to those that may hear the news and have questions.
Forbes D. Porter, MD, PhD
Senior Investigator, PDEGEN, NICHD, NIH
Program Head, PDEGEN, NICHD, NIH
Clinical Director, NICHD, NIH