These are the KEI comments on the questions raised by the FDA in the 85 FR 33165 and 85 FR 33169 Federal Register notices. KEI-comments-FDAOrange Book-31aug2020 KEI comments to the FDA relating to the Approved Drug Products With Therapeutic Equivalence… Continue Reading
Through a Freedom of Information Act (FOIA) request, Knowledge Ecology International (KEI) has obtained 311 pages of correspondence between officials from the Office of the US Trade Representative (USTR) and employees of the Motion Picture Association (MPA), the Recording Industry… Continue Reading
COVID-19 Gov’t Contracts: KEI has obtained numerous contracts between the federal government and pharmaceutical companies regarding COVID-19 medical technologies via the Freedom of Information act. For these and other contracts, please see: https://www.keionline.org/covid-contracts. COVID-19 Vaccine Manufacturing: KEI has gathered data… Continue Reading
Through a Freedom of Information Act request, KEI has obtained records relating to US Trade Representative Ambassador Robert Lighthizer’s attendance at the 2018 World Economic Forum in Davos, Switzerland. While many of the records were related to scheduling and re-scheduling… Continue Reading
We now keep track of our FOIA requests here. Recent NIH FOIAs: https://www.keionline.org/foia/nih Older logs and pages about selected Freedom of Information Act (FOIA) requests filed by KEI. Centers for Disease Control and Prevention (CDC) March 3, 2015: CDC FOIA… Continue Reading
The following PDF file includes several email exchanges between Pfizer and USTR regarding Colombia’s accession to the Organisation for Economic Co-operation and Development (OECD). Pfizer proposed several conditions it wanted Colombia to agree to before the US would withdraw objections… Continue Reading
The attached document is a 78 page PDF file obtained from USTR under the Freedom of Information Act (copy here), regarding communications between Gilead and USTR, over Malaysia’s decision to grant a compulsory license on patents for HCV treatments. This… Continue Reading
UPDATE: On July 13, 2018, KEI received a response to our comments on the prospective license to be given to ERYTHRYx Therapeutics. The brief response simply stated that NIH had already assessed the company to meet their technical and financial… Continue Reading
Update: the NIH has rejected our request for expedited processing of the FOIA, on the grounds that KEI did not demonstrate “that there exists an urgency to inform the public” about the costs of the NIH CAR T or mesothelin… Continue Reading
In the area of Transparency, KEI works on several different topics, including for example: Norm setting. KEI has advocated access to meeting venues, timely disclosures of negotiating texts, and the use of webcasting of meetings, among other measures. Trade negotiations… Continue Reading