KEI Letter to US House Oversight Committee on NIH Misconduct and Lack of Transparency

On July 22, 2019, Knowledge Ecology International submitted a letter to the US House of Representative’s Committee on Oversight and Reform regarding the National Institutes of Health’s (NIH) lack of transparency in its exclusive licensing processes.

Prior to executing an exclusive license to a medical technology developed by taxpayer-funded research at the NIH, the agency must follow certain procedures, including notifying the public and soliciting its comments through a posting in the Federal Register notice.

Since 2015, KEI has commented on more than 40 exclusive licenses proposed by the NIH. KEI’s letter to the House Oversight Committee lays out how our attempts to obtain basic information from the NIH regarding the prospective licenses have been met with unnecessary secrecy and avoidance, and how the NIH’s misconduct and obfuscation possibly violates the law and harms the American public.

The letter outlines:

  • Background Information
  • The NIH’s Lack of Transparency
    • Scope of the license
      • Years of exclusivity
      • Geographic area
    • Stage of R&D completed and funding contributed by the NIH
      • The CD30 CAR Multiple Myeloma Trial
    • Information about the prospective licensee
    • Antitrust considerations
    • How NIH applies Section 209 criteria and considers comments
  • Other Problematic Behavior by the NIH
    • Failure to provide documents to KEI within the comment period
    • Failure to make the NIH’s appeal procedures publicly available

A PDF of the full text of the letter is available here: KEI_Letter_HouseOversightCommittee_ NIH_Lack_of_Transparency_22July2019