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
On Monday March 23, 2020, Gilead Sciences’ remdesivir received orphan designation from the US Food and Drug Administration (FDA) for the treatment of COVID-19. Remdesivir has been reported to be one of the candidates to potentially treat COVID-19, which the… Continue Reading
Zolgensma is a gene therapy for spinal muscular atrophy (SMA) that was approved by the US FDA in May 2019, at a price of $2.1 million per patient. Zolgensma was licensed from a children’s hospital where it was developed on… Continue Reading
On August 20, 2018, KEI filed comments in response to the US Federal Trade Commission’s hearings and public comment process to address, “Competition and Consumer Protection in the 21st Century.” The goal of the process is to examine, “whether broad-based… Continue Reading
Knowledge Ecology International and 43 other health-care interested groups are calling on Congress to pass the CREATES Act. The CREATES Act, or the “Creating and Restoring Equal Access To Equivalent Samples Act of 2017”, is a bipartisan proposal to speed… Continue Reading