KEI Sues NIH over Improper Withholding of Three FOIA Requests

On September 29, 2020, Knowledge Ecology International (KEI) filed a lawsuit against the National Institutes of Health (NIH) regarding three Freedom of Information Act (FOIA) requests filed by KEI. The complaint filed by KEI requests injunctive, declaratory, and other appropriate relief, and seeks the release of records improperly withheld from KEI by the NIH. The three FOIA requests cover several topics, but in all instances, the NIH has failed to provide responsive records or issue a final response to the requests at issue within the deadline established by the FOIA.

The FOIA requests included in the lawsuit are discussed briefly below.

Request No. 47589—Dr. Francis Collins’ Correspondence with the Pharmaceutical Industry

On February 20, 2018, KEI submitted a FOIA request to the NIH seeking:

“the correspondences of the National Institutes of Health (NIH) Director, Dr. Francis Collins, with persons representing pharmaceutical or biomedical companies, the trade associations PhRMA or BIO, university technology transfer offices, the Foundation for the National Institutes of Health, banks or other entities that make investments in biomedical companies.”

KEI and the NIH then exchanged several emails clarifying the scope of the request, as the NIH asserted that the initial request did not “reasonably describe the records sought”. The NIH sent an email on September 9, 2019, confirming the agreed upon terms of the records search, and has failed to provide a response in the more than a year that has passed since that date.

Request No. 53325—Intramural Recordkeeping Procedures

In the course of KEI’s research on medical research and development costs, KEI has asked the NIH for information concerning the costs of NIH-conducted clinical trials however, the NIH has asserted on multiple occasions that it does not maintain a record of the costs of its intramural clinical trials. On September 25, 2019, KEI submitted a FOIA request to the NIH seeking:

“all documents referring to the National Institutes of Health (NIH)’s procedures for maintaining records of budgets and/or expenses associated with NIH intramural clinical trials.”

The NIH has failed to provide responsive records, issue a final response, or even respond to KEI’s multiple requests for an update on the status of this request.

Request No. 54587—Dr. Mark Rohrbaugh’s Correspondence about KEI

Since 2015, KEI has regularly submitted comments to the NIH in response to Federal Register notices concerning proposed exclusive licenses from the NIH to private companies. The NIH’s posts announcing the licenses contain limited information regarding the technologies to be licensed, their states of development, NIH investments in the technologies, and basic information about the private companies set to receive the exclusive licenses. In light of this, KEI regularly asks the indicated NIH point-of-contact for more information on the proposed licenses so as to inform the comments we intend to file.

KEI has been repeatedly denied this information and given dismissive answers from the NIH regarding basic information about potentially important technologies to treat major diseases. On at least one occasion, Dr. Mark Rohrbaugh, Special Advisor for Technology Transfer with the NIH, has advised an NIH point-of-contact for a prospective exclusive license to not answer KEI’s questions regarding the license. On June 18, 2020, KEI submitted a FOIA request to the NIH seeking all correspondence to and from Dr. Rohrbaugh that mention and/or concern KEI, KEI Director James Love, our previous Counsel Andrew Goldman, and our current Counsel Kathryn Ardizzone.

To date, the NIH has failed to provide responsive records or issue a final response to this request within the deadline established by the FOIA.

KEI’s full complaint (8:20-cv-02825-PJM) filed with the US District Court for the District of Maryland (Southern Division) is available here: KEI_NIH_FOIA_Complaint_29Sept2020

Claire Cassedy