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February 28, 2022

Senate Confirms New Food and Drug Administration Commissioner

  • Government Relations News

Robert M. Califf, MD, was sworn in as the new commissioner of the U.S. Food and Drug Administration (FDA) on February 17, 2022.

Previously, Dr. Califf served as FDA commissioner from February 2016–February 2017. Prior to rejoining the FDA, Dr. Califf was head of medical strategy and senior advisor at Alphabet Inc., contributing to strategy and policy for its health subsidiaries, Verily Life Sciences and Google Health. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute.

A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, health-care quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,300 publications in the peer-reviewed literature.

Dr. Califf will now oversee the federal agency tasked with finalizing and implementing over-the-counter hearing aid regulations.

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The U.S. Department of Health and Human Services Office of Inspector General (OIG) posted on October 25, 2023 Advisory Opinion No. 23-08, in which OIG rejected a proposed arrangement from a cochlear implant device manufacturer (the requestor) that would provide a free hearing aid to certain qualified patients who received a cochlear implant. OIG concluded the…

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On November 17, 2023, Representative Gus Bilirakis (R-FL) and Matt Cartwright (D-PA) introduced the Medicare Audiology Access improvement Act (H.R. 6445). This legislation is also co-sponsored by Representatives Johnson (R-OH), Shakowsky (D-IL), Mace (R-SC), Blunt Rochester (D-DE), Fitzpatrick (R-PA), Trone (D-MD), Webster (R-FL), Cohen (D-TN), LaMalfa (R-CA), Grijalva (D-AZ), Foster (D-IL) and Pocan (D-WI). Senators Elizabeth…

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