March 7, 2022 – Newly appointed Food and Drug Administration Commissioner Robert Califf, M.D., who is returning to the position he briefly held during the Barack Obama administration, faces a daunting challenge as he begins anew: coming to terms with how the agency’s controversial accelerated approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease affects […]
Read more Feb. 21, 2022 – During President Joe Biden’s first year in office, his administration’s health policy team has faltered, made missteps and miscalculations on COVID-19 decisions and communication, and took more than a year to secure a permanent Food and Drug Administration Commissioner (Robert Califf, M.D., was confirmed to take the helm on Feb. 15). […]
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Feb. 7, 2022 – Although the nomination of Dr. Robert Califf to return as FDA Commissioner was advanced by the Senate House, Education, Labor, and Pensions (HELP) Committee just weeks ago and it appeared Califf was poised to be confirmed by the full Senate, new opposition to his nomination reportedly has switched at least some […]
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June 7, 2021 — Despite ongoing speculation about who will be the next Commissioner of the Food and Drug Administration (FDA), “the real leadership story is at CDER,” the Center for Drug Evaluation and Research, according to Kate Rawson, senior editor of Prevision Policy. As Rawson explained during a June 4 webinar on “What’s Ahead […]
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April 26, 2021 – What happens in Washington doesn’t stay in Washington, and upcoming webinars will examine two of the areas most critical to healthcare marketing and communications: the use of personal data and protecting privacy, and what’s ahead for the FDA under new leadership. Registration is now open here for the two webinar programs, […]
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Jan. 11, 2021 – When considering all of the COVID-19 challenges the FDA faced in 2020, it is noteworthy that the Center for Drug Evaluation and Research (CDER) approved 53 novel drugs last year, the second highest number of novel drug approvals in the past 10 years. In a forward to CDER’s 2020 report on […]
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Dec. 7, 2020 – President-elect Joe Biden announced on Dec. 7 his plans for filling key public health positions, including nominations for California Attorney General Xavier Becerra to be the next secretary of Health and Human Services and Dr. Rochelle Walensky, currently an infectious disease specialist at Massachusetts General Hospital, to become director of the […]
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Nov. 30, 2020 – Job one for President-elect Joe Biden is the response to the COVID-19 pandemic, which will represent a “marked difference in energy and tone” than that offered by the current administration and likely will include a new FDA Commissioner as well as the roll-out of COVID-19 vaccines, according to Kate Rawson, senior […]
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Nov. 20, 2020 – In a rare special fraud alert issued Nov. 16, the Department of Health and Human Services Office of Inspector General (OIG) expresses skepticism about the value of company-sponsored speaker bureau events, outlines its concerns about “inherent fraud and abuse risks” associated with these programs, and offers a non-exhaustive list of the […]
Read more With a bitterly-contested campaign headlined by pandemic and recession nearly in the rear-view mirror and just days to go before the Nov. 3 election, communications and marketing professionals need to understand what the healthcare environment will look like when the dust settles. To help industry sort through the results and what they may mean for […]
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