NIH Again Closes Drug Product Manufacturing Facilities and Halts Clinical Studies

May 1, 2016

By Jay W. Cormier

The National Institutes of Health (NIH) recently announced that it would be suspending drug manufacturing at two of its facilities after preliminary findings by two outside consulting groups found that certain sterile products were not manufactured in compliance with GMP quality standards.  As a result, clinical studies using the drug products at these facilities that are subject to this suspension will, in turn, be halted until NIH can bring its manufacturing facilities into compliance. 

Recall that last summer, two NIH manufacturing facilities were inspected by FDA and issued a scathing Form 483 (see our earlier post here).  It isn’t exactly clear whether the two facilities mentioned in this latest press release (a National Cancer Institute laboratory engaged in cell therapy production and a National Institute of Mental Health facility producing positron emission tomography (PET) materials) are different than the two facilities that were closed immediately following the 2015 inspection (those two facilities were the Pharmaceutical Development Section and Clinical Center Pharmacy).  We attempted to clarify this with NIH contact listed on the press release, but our calls have not been returned. 

If it is the same facilities, it seems odd to us that NIH would announce the closure of the same facilities twice.  So, we are inclined to believe that these recent closures bring the total drug product manufacturing facilities have been at least partially closed due to a lack of cGMP compliance to four facilities.  If this is the case, it is very interesting as we cannot recall an instance where a manufacturer voluntarily shut down two of its facilities in response to a company-wide review of manufacturing facilities following negative inspectional findings at two other of its facilities.

Adding a twist to the whole story, in December, NIH formed the Clinical Center Working Group of the Advisory Committee to the Director (which NIH refers to as the “Clinical Center Red Team”), whose charge is defined as:

To make recommendations about ways to enhance the organization, financing, and management of the clinical center to improve the quality of patient care, and reduce the risk of clinical research and research-related activities. To inform its deliberations, the working group may examine the structural and cultural issues at the Clinical Center that may have contributed to the deficiencies identified in the Pharmacy and Pharmaceutical Development Service, and review other research activities at the Clinical Center that pose a potential risk to research participants.

The Clinical Center Working Group was expected to deliver its report to the full Advisory Committee to the Director on Thursday, April 21st in a meeting scheduled from 4-6pm.  Setting aside for a moment (or rather for a later post) that it has taken NIH almost a year to receive this report – an eternity in the world of major cGMP violations – we are glad to see that the Working Group is producing its report.  Although NIH announced that the report would be delivered to the NIH Advisory Committee at a specific date and time, a week later NIH has yet to disclose either the report or a summary of its contents.  We look forward to hearing about the report and to seeing what additional changes NIH makes to its drug manufacturing practices. 

We will be watching to see if the report or any summary of it is made public.  Because of the significance of the issues at NIH, and that NIH is funded through taxpayer funds, we urge NIH to make the report public expeditiously. 


Categories: Drug Development