WASHINGTON, DC - House Energy and Commerce Committee leaders this week sent a letter to National Institutes of Health Director Dr. Francis Collins regarding a recent drug manufacturing facility closure and the impact that has had on patients in NIH clinical trials. The letter, signed by Chairman Fred Upton (R-MI) and Oversight and Investigations Subcommittee Chairman Tim Murphy (R-PA), is a continuation of the still-ongoing investigation of the NIH Clinical Center Pharmaceutical Development Section (PDS).
In the letter to Dr. Collins, Upton and Murphy acknowledged the NIH’s efforts to work with the committee in addressing this issue, but expressed concern for impacted patients. They write, “But we don’t believe that the welfare of patients in experimental trials who are dependent upon drugs manufactured in the PDS should be compromised while responsibility for the problems with the PDS is being ascertained. It should be NIH’s and your responsibility to ensure that every effort is made to provide for the continuing care of these patients, especially at this time when many may be harmed by the apparent suspension of treatment."
Upton and Murphy add, “At the present time, the committee’s specific focus is on questions related to the welfare of all the patients in NIH clinical trials affected by disruptions because of the suspension of PDS operations." The leaders reference a response from the NIH to the committee’s July 31, 2015, letter. “NIH reported that there were 1,332 patients enrolled in 62 affected protocols. NIH’s narrative response stated that most patients were not affected by the clinical holds because they were not scheduled to receive their study drug during the time of the suspension. Patients who were scheduled to receive their study drug were evaluated on a case by case by the [Food and Drug Administration]."
Upton and Murphy continue, “However, information in the charts attached to the NIH’s narrative response, and other information that has come to the attention of the committee, substantiate our grave concerns that patients in several protocols were and continue to be harmed by the disruption caused by the PDS problems. … It has also come to the attention of the committee that one patient had been receiving and benefitting from treatment that was discontinued because of the PDS issues. This patient with a grave illness received a form letter from the NIH which stated that the treatment was being withheld because of the PDS problems. There was no follow-up from NIH. … The NIH reported to majority committee staff that the researcher did not seek waivers with the FDA because the process was too bureaucratic, even though other NIH researchers had done so. To not follow up with these patients, to just leave them hanging, and with no compassion, falls into the definition of ‘patient abandonment’ and cannot be tolerated."
Read the complete letter online HERE.
