[Ip-health] KEI Letter to US House Oversight Committee on NIH Misconduct and Lack of Transparency

Claire Cassedy claire.cassedy at keionline.org
Tue Jul 23 07:50:02 PDT 2019


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

Posted on July 22, 2019 by Claire Cassedy

On July 22, 2019, Knowledge Ecology International submitted a letter[1] 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[2]
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:

[2] https://www.keionline.org/nih-licenses

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