NIH Research Drug Prep Shutdown Raises Concerns From House

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By Jeannie Baumann

Oct. 2 — A House panel has “grave concerns” about whether any NIH patients were harmed after the suspension of the program responsible for managing investigational drugs in the agency's research hospital, according to a letter released Oct. 1.

The letter is part of an ongoing investigation by the House Energy and Commerce Subcommittee on Oversight and Investigations following a decision in June by the National Institutes of Health to suspend preparation of all sterile materials in the Pharmaceutical Development Section in the NIH Clinical Center, the world's largest research hospital. The PDS makes products for certain clinical research studies conducted in the hospital and collaborating facilities, and the suspension was the result of an inspection that identified several systemic and sterility issues such as finding bacteria growth on some batches of products made at the facility (9 LSLR 736, 6/26/15).

“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.”
—Reps. Fred Upton (R-Mich.) and Tim Murphy (R-Pa.

Specifically, the lawmakers questioned whether putting some research protocols on hold led to delays for patients who needed critical treatments, ranging from transplants to vaccines. In the letter to NIH Director Francis S. Collins, Reps. Fred Upton (R-Mich.) and Tim Murphy (R-Pa.) said the NIH's Sept. 10 response to the subcommittee's July 31 letter didn't fully address the panel's concerns about the impact of the PDS suspension on patients. Upton and Murphy acknowledged that the NIH has made efforts to work with the committee to address the PDS suspension.

Continuing Care Responsibility

“We appreciate that these problems require a thoughtful and prudent response. 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,” they wrote to Collins. “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 is the chairman of the House Energy and Commerce Committee; Murphy is the chairman of the oversight subcommittee.

According to their letter, which is dated Sept. 29 and was released Oct. 1, the PDS suspension affected 62 research protocols involving 1,332 patients. The NIH told the Energy and Commerce subcommittee that placing a clinical hold on these protocols didn't affect most patients because they weren't scheduled to receive their study drug during the suspension. For those patients who were scheduled to receive their study drugs, the NIH said, the Food and Drug Administration evaluated those cases individually.

The letter highlighted the case of one patient who had been benefiting from a treatment for a “grave illness” at the clinical center, but that treatment was cut off due to the PDS suspension. According to Upton and Murphy's letter, that patient received a form letter that the treatment was being withheld, but there was never any follow-up from the NIH in more than two months, nor has that patient received any treatments from the NIH. The agency already told lawmakers that they're investigating this matter.

“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,” Upton and Murphy said.

NIH Response

In response to a request for comment, the NIH told Bloomberg BNA Oct. 2 that “the NIH Clinical Center closed its Pharmaceutical Development Section (PDS) as a result of contamination and has acted with an abundance of caution with respect to the safety of research participants.” The NIH said it has been working with the FDA and has developed a process for all affected studies to explore alternative sources for experimental products or request permission for participants to receive products from the PDS inventory.

“NIH has a strong commitment to safety and we will continue to take every measure to protect research participants,” the NIH statement said. “Dr. Collins will be responding to the letter.”

Upton and Murphy asked Collins to respond by Oct. 6 to a series of questions and requests for lists:

  • What is the status of each of the patients since the experimental treatments stopped
  • How many patients are currently not getting their study treatments? How many patients had their study treatment withheld but have since been able to resume getting treatment
  • Have all patients been contacted about the status of their study?
  • What is the status of each patient's study
  • a list of the NIH researchers who sought and got waivers from the FDA for their patients
  • a list of the NIH researchers who didn't seek and get waivers from the FDA fro their patients
  • a list of the NIH researchers who sought and got alternative sources of treatment
  • a list of the NIH researchers who didn't seek nor did they get alternative sources of treatment
  • Is there anyone at the NIH, or a contractor, tasked with the responsibility of overseeing the status of care of all patients in the NIH studies disrupted by the PDS issues? and
  • Is the NIH internal task force that is reviewing PDS issues also examining the impacts and statuses of patients in NIH studies disrupted by the PDS issues?

“We need answers immediately about every study, every patient, and what NIH intends to do about them,” Upton and Murphy said.

To contact the reporter on this story: Jeannie Baumann in Washington at

To contact the editor responsible for this story: Randy Kubetin at

The House Energy and Commerce letter is available at

The FDA inspection details are available at

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