January 19, 2021

Around the nation: Biden selects former FDA chief to lead Operation Warp Speed

Daily Briefing

    President-elect Joe Biden has chosen David Kessler—pediatrician, lawyer, and former head of FDA under former Presidents George H.W. Bush and Bill Clinton—to help lead Operation Warp Speed, in today's bite-sized hospital and health industry news from the District of Columbia and New York.

    • District of Columbia: President-elect Joe Biden has chosen David Kessler—pediatrician, lawyer, and former head of FDA under former Presidents George H.W. Bush and Bill Clinton—to help lead Operation Warp Speed. Kessler, who serves as co-chair of the Covid-19 task force on Biden's transition team, will replace Moncef Slaoui, a researcher and former drugmaker executive, who will serve instead as a consultant to the task force. Kessler will divide his responsibilities with Gen. Gustave Perna, who will continue to be Operation Warp Speed's COO. In his new role, Kessler will oversee distribution, manufacturing, and the overall effectiveness and safety of Covid-19 vaccines and treatments (Kaplan, New York Times, 1/15).
    • District of Columbia: HHS on Thursday released a new policy allowing physicians to prescribe buprenorphine, a drug used to treat substance use disorder, without first obtaining a special federal waiver, called the "X-waiver," that can only be acquired by completing an eight-hour training course. Under the new policy, any physician who has a prescriber license of the Drug Enforcement Administration (DEA) will be permitted to prescribe the drug to up to 30 in-state patients at any one time; if they do opt to obtain the waiver, they will be allowed to prescribe the drug to up to 275 patients. Hospital physicians are exempted from the cap. Meanwhile, non-physician providers—such as NPs and PAs—will still have to apply for waivers to prescribe the drug at all. Several provider groups praised the move, including the American Medical Association and the American College of Emergency Physicians (Diaz/Mann, NPR, 1/15; Facher, STAT News, 1/14).
    • New York: The tele-mental health care company Talkspace on Wednesday announced it was going public via a merger with Hudson Executive Investment Corp, a special purpose acquisition organization that is sponsored by Hudson Executive Capital. The agreement, which is scheduled to close at the end of the first quarter of 2021, values Talkspace at $1.4 billion. Under the agreement, Talkspace co-founders Oren and Roni Frank will stay at the helm of the organization, while Douglas Braunstein, founder and managing partner of Hudson Executive Capital, will serve as chair of the organization's new board of directors (Aguilar, STAT News, 1/13; Talkspace press release, 1/13).
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