By Jay W. Cormier –
As readers of this blog may recall, FDA observed remarkable conditions at two facilities on the NIH campus in Bethesda, MD (see our post here). Then, earlier this year, NIH stated again that it was closing its drug manufacturing facilities (see our post here). What wasn’t clear in April was whether the facility closures were the same facilities as were the subject of the 2015 inspection. A newly released letter from FDA to NIH, however, confirms that the facilities were, in fact, the same facilities.
In that letter from FDA, dated July 29, 2016, FDA provides a number of new details regarding the ongoing manufacturing issues at NIH. Specifically, we learn that:
- NIH officially notified FDA in May of its April decision to close the NIH Pharmaceutical Development Section (PDS) facility;
- NIH currently has not determined whether or when it will attempt to re-open the PDS facility;
- NIH has developed plans to build a new sterile product manufacturing facility to replace the Intravenous Admixture Unit (IVAU) that was closed immediately after the 2015 inspection;
- FDA believes that the proposed new IVAU “represent[s] a substantial improvement over [the] current IVAU” and that NIH should “move to the new interim IVAU as quickly as possible”; and
- NIH has indicated to FDA that the new interim IVAU will open by October 31st.
Given the numerous and significant violations that were observed in the IVAU and PDS, it is not surprising that any proposed new interim IVAU would present a significant improvement over the prior facility, but we applaud NIH’s efforts to restart its important drug manufacturing operations that are such a critical component of so many NIH clinical studies.
We will continue to monitor NIH’s remediation efforts.