On February 6, 2024, KEI submitted comments to the National Institute of Standards and Technology (NIST) regarding the Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights (88 FR 85593). This set of comments outlined that the draft… Continue Reading
The National Institute of Standards and Technology (NIST) issued a Request for Information on December 8, 2023 regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593). The request follows a nearly year-long interagency… 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
On December 19, 2023, three prostate cancer patients, Robert Sachs, Clare Love and Eric Sawyer, sent a letter to Secretary Becerra asking that he act on their appeal of the rejection of their petition, asking the federal government to use… Continue Reading
The U.S. Federal Trade Commission (FTC) mission “is protecting the public from deceptive or unfair business practices and from unfair methods of competition through law enforcement, advocacy, research, and education.” https://www.ftc.gov/about-ftc/mission The advocacy role of the FTC includes to “Advance… Continue Reading
On March 23, 2023, three prostate cancer patients, Robert Sachs, Clare Love and Eric Sawyer, filed an administrative appeal of the NIH decision to reject petition that HHS use Federal rights in patents on Xtandi to address pricing discrimination against… Continue Reading
NIH has sent a letter, dated Dec 1, to Robert Sachs and Clare Love, regarding the longstanding petition to HHS to use the federal government’s rights in the patented inventions for enzalutamide, marketed by Astellas in the USA at prices 3 to… Continue Reading
SecBecerra-18Nov2022-Sachs-Love-Xtandi November 18, 2022 Xavier Becerra Secretary Department of Health & Human Services Washington, DC Via Email: xavier.becerra@hhs.gov Dear Secretary Becerra: Today marks the one-year anniversary since the undersigned prostate cancer patients petitioned the Department of Health & Human Services… Continue Reading
On Wednesday May 11, 2022, the National Institutes of Health (NIH) was asked about Xtandi and march-in rights during a Congressional hearing. The House Appropriations Committee held a hearing on the FY2023 Budget Request for the NIH, and Representative Mark… Continue Reading
(More on this topic here: https://www.keionline.org/xtandi2021) On February 24, 2022, Senators Thom Tillis and Marsha Blackburn sent a letter to HHS Secretary Xavier Becerra (PDF copy). The letter refers to “petitions to march-in on a pharmaceutical product purely based on… Continue Reading