KEI submitted comments to 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) regarding the 2002 Bob Dole and Birch… Continue Reading →
KEI submitted comments to the National Institute of Standards and Technology (NIST) in response to the Request for Information regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593) concerning Bayh-Dole rights and the… Continue Reading →
On January 10, 2023, twenty-five Members of Congress sent a letter to HHS Secretary Xavier Becerra urging him to act on the Xtandi request, and to use the Bayh-Dole Act to lower the price of Xtandi (enzalutamide) for US patients.… 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 →
(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 →
This is a letter from the three prostate cancer patient petitioners to HHS Secretary Becerra and Acting NIH Director Tabak, regarding the February 9, 2020 statement by Astellas on the Bayh-Dole march in and government rights case. The patient’s letter… Continue Reading →
Update: Video recording of the press briefing available here: https://www.youtube.com/watch?v=KwqUl7NLMXo) December 15th 10AM – Briefing on Xtandi March-in Request Supporters of the march-in petition to lower the cost of the prostate cancer drug Xtandi will host a virtual press conference… Continue Reading →
On July 9, 2021, the Biden White House has issued an Executive Order on competition which includes opposition to the Trump effort to narrow Bayh-Dole march-in rights over pricing concerns. This is the first time since 1995 there has been… Continue Reading →
The number of standard and material CRADAs executed by the NIH from 1985 to 2020 and the relationship to NIH reasonable pricing clause KEI Briefing Note 2021:3 James Love April 5, 2021 KEI-BN-2021-3