(More on Moderna here: https://www.keionline.org/moderna) KEI received a letter Dr. Gary Disbrow, the Acting Director of BARDA, just before noon today. BARDA2KEI.Moderna.Patent.Disclosures.20200903 The BARDA investigation follows the announcement on Saturday that DARPA was also investigating DARPA’s failures to disclose DARPA… Continue Reading
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
On 29 June 2020, the World Health Organization (WHO) published a document (A73/INF./3, 29 June 2020), entitled, “Voluntary contributions by fund and by contributor, 2019“. Total voluntary contributions to WHO’s Total General Fund in 2019 amounted to $2,443,961,432; in 2018,… Continue Reading
On Friday, 24 July 2020, Italy officially published the long-anticipated Pricing and Reimbursement Decree in the Gazzetta Ufficiale della Repubblica Italiana setting in motion Italy’s place as the first country to implement the WHO transparency resolution (WHA72.8). In statement before… Continue Reading
(More on Moderna here: https://www.keionline.org/moderna) On July 31, 2020, Knowledge Ecology International and Public Citizen sent Biomedical Advanced Research and Development Authority (BARDA) a letter asking BARDA to enforce a term of Moderna’s billion dollar contract with BARDA to develop… Continue Reading
KEI has a number of outstanding requests under the United States Freedom of Information Act (FOIA) for contracts related to biomedical innovations to control or treat the COVID-19 pandemic. On Thursday, June 25, and Friday, June 26, we received a… Continue Reading
On June 3, 2020, the U.S. Government Accountability Office (GAO) sent KEI four questions about the transparency of the intellectual property HHS owns and how HHS manages those rights. On June 22, 2020, we sent this response. KEI response to… Continue Reading
Other Transaction Agreements: Government Contracts that May Eliminate Protections for the Public on Pricing, Access and Competition, Including in Connection with COVID-19 KEI Briefing Note 2020:3 June 29, 2020 (revision of June 24 version) Kathryn Ardizzone James Love The most… Continue Reading
May 4, 2020 Comments of Knowledge Ecology International Regarding “Purple Book Enhancement; Establishment of a Public Docket; Request for Comments” (FDA-2020-N-0437) Knowledge Ecology International (KEI) provides the following comments regarding the Food and Drug Administration [FDA]’s Purple Book Enhancement. Our… Continue Reading
Below are Freedom of Information Act (FOIA) requests filed by KEI related to issues concerning the coronavirus/COVID-19 pandemic. This page will be updated as we file requests and receive responses. Department of Health and Human Services Centers for Disease… Continue Reading