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
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
Today, Knowledge Ecology International (KEI) submitted a letter to the Commissioner of the Food and Drug Administration (FDA) regarding the mismatch between the cost to perform pediatric extension trials and the cost to the public of the six month extension… Continue Reading
Submission to FDA: Video Ads for Prescription Drugs and Vaccines that use Distracting Images or Music when Risks are Presented KEI Research Note 2023:1 May 15, 2023 KEI-RN-2023-1-Distracting-Music-Images-in-Pharma-Ads (Note: Submitted to Regulations.gov in support of Citizen Petition FDA-2020-P-1725, “Request that… Continue Reading
In 2020, KEI filed a citizens petition with the FDA, asking for a rule banning the use of background music during the presentation of the risks in direct to consumer drug advertising. The 2020 KEI petition is here: https://www.regulations.gov/document/FDA-2020-P-1725-0001 The… Continue Reading
In a January 31, 2022 letter to Drew Hirshfeld, the Commissioner for Patents for the USPTO, and Janet Woodcock, the Acting Commissioner of the FDA, Senator Thom Tillis provides extensive criticism of the empirical work of the group I-MAK and… Continue Reading
To: Ken Millburne Technology Transfer Program Food and Drug Administration Via email: Kenneth.millburne@fda.hhs.gov From: James Love Knowledge Ecology International 1621 Connecticut Avenue NW, Suite 500 Washington, DC 20009 https://keionline.org Date: November 30, 2020 Re: Prospective Grant of an Exclusive Patent… Continue Reading
Knowledge Ecology International (KEI), the Center for Digital Democracy (CDD), and three individuals, Manon Ress, Professor Liza Vertinsky, from Emory Law School and Dr. Reshma Ramachandran, a fellow at Yale University School of Medicine, have filed a citizens petition with… 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