House Committee Questions FDA about NIH Shutdown

Members of the House Energy & Commerce Committee are giving the FDA until Aug. 14 to provide information on whether NIH included any statements about quality control, sterility or cGMP compliance in INDs it filed with the agency.

The panel also wants to know how often people were exposed to unreasonable risk and how many submissions were placed on clinical hold, according to a letter sent to FDA Acting Commissioner Stephen Ostroff.

The NIH shut down its Pharmaceutical Development Section on June 4 after a May 10 to 29 inspection found serious deviations from good manufacturing practices and standard operating procedures. PDS compounds drugs for use by NIH’s Clinical Center.

The committee points out that FDA staff visited PDS in 2012 and prepared a draft inspection assignment, but it was never finalized or issued.  The panel wants to know why the inspection never occurred and to see documentation regarding that decision.

The May inspection followed an unspecified complaint and resulted in a 17-observation Form 483. In April, two vials of albumin — used when administrating interleukin in experimental studies — were discovered to have fungal contamination, according to NIH. Vials from the same batch were administered to six patients who were notified and have been followed for signs of infection.

At the time of the shutdown, NIH reported that about 250 participants in 46 studies were potentially affected, as they received products manufactured by PDS. Responding to the committee, NIH says it is working with the FDA and investigators to identify the alternative drug sources for each of the studies, taking into consideration time sensitivities related to clinical research and patients’ needs.

The FDA declined to comment on the inquiry. Read the letter to Ostroff at www.fdanews.com/08-04-15-FDAletter.pdf and the letter to NIH Director Francis Collins at www.fdanews.com/08-04-15-NIHletter.pdf. — John Bechtel