On October 3, 2023, Knowledge Ecology International (KEI) sent a letter to the FDA asking the agency to publish its historical Orange Book data. The Orange Book identifies patent and exclusivity data for FDA approved drug products. The FDA publicly… Continue Reading
On December 8, 2023, the National Institute of Standards and Technology (NIST) issued a Request for Information regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593). Today KEI submitted comments to NIST regarding… Continue Reading
As a part of the workshop hosted by the National Institutes of Health (NIH) on July 31, 2023 on the topic of, “Transforming Discoveries Into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer,” the NIH solicited public comments. In addition… Continue Reading
KEI Comments in response to the Office of Science and Technology Policy (OSTP) Request for Information (RFI), regarding National Priorities for Artificial Intelligence, as noticed on May 23, 2023 in the Federal Register, 88 FR 34194. July 7, 2023 Knowledge… Continue Reading
On Monday January 31, 2022, Knowledge Ecology International (KEI) Doctors Without Borders/Médecins Sans Frontières (MSF) USA, Doctors for America, the Drugs for Neglected Diseases Initiative, Professor Chris Morten of Columbia Law School, and 33 supporting organizations sent a letter to… Continue Reading
A $265 million COVID-19 vaccine manufacturing contract between the Department of Health and Human Services (HHS) and the Texas A&M University System (TAMUS) to manufacture the Novavax and other COVID-19 vaccines demonstrates that a manufacturing facility can be retrofitted to… Continue Reading
In February 2020, the World Trade Organization (WTO) de-restricted the minutes of the TRIPS Council’s October 2019 session. While the official minutes (IP/C/M/93/Add.1) were circulated to WTO members on 9 December 2019, the October 2019 minutes were only available to… Continue Reading
(UPDATE: The NIH provided responses to our comments on August 14, 2019: 84 FR 33272 Response and 84 FR 33270 Response) On Monday July 29, 2019, Knowledge Ecology International (KEI) submitted joint comments to the NIH on behalf of KEI,… Continue Reading
Today the World Health Assembly (WHA) approved A72/A/CONF./2 Rev.1 as a resolution, titled “Improving the transparency of markets for medicines, vaccines, and other health products.” Link to the resolution: http://apps.who.int/gb/ebwha/pdf_files/WHA72/A72_ACONF2Rev1-en.pdf When the text was made available, I sent out a… Continue Reading
On Thursday May 23, 2019, KEI, Doctors without Borders/Médecins Sans Frontières (MSF), and 44 more organizations and 10 individuals released an open letter to delegates of the 72nd World Health Assembly urging them to support a strong resolution on transparency… Continue Reading