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FDA Acting Commissioner Janet Woodcock. Photo: Bill Clark/CQ-Roll Call, Inc via Getty Images

Public Citizen is asking Health and Human Services Secretary Xavier Becerra to fire three top FDA officials — Janet Woodcock, Patrizia Cavazzoni and Billy Dunn — over the agency's "indefensible decision to approve" Biogen's Alzheimer's treatment, Aduhelm, according to a letter the consumer advocacy group sent today.

Why it matters: The FDA increasingly has approved drugs that come with high price tags but have weak or no clinical evidence of working, like Aduhelm, and now more scientists and medical experts are calling for an overhaul of the agency's leadership.

Go deeper

FDA needs more time on Juul e-cigarette ban decision

The Food and Drug Administration said Thursday it will delay its decision on top-seller Juul, but thousands of other electronic cigarettes will be ordered off the U.S. market.

Why it matters: The stalled decision prolongs the agency's determination on whether there is enough data to show if adult cigarette smokers switching to a less harmful option outweighs the detrimental costs of young people getting hooked on nicotine by vaping.

Updated Sep 10, 2021 - Axios Events

Watch: A conversation on what's working to get Americans vaccinated

On Friday, September 10, Axios health care reporter Caitlin Owens and health care editor Tina Reed hosted a virtual conversation on what strategies are working to get Americans vaccinated, featuring former FDA Commissioner Dr. Scott Gottlieb and Walgreens Chief Medical Officer Dr. Kevin Ban.

Dr. Scott Gottlieb spoke about reducing vaccine hesitancy, an increase of COVID-19 cases in conjunction with the return to school, and how to ensure the effective distribution of booster shots when the time comes.

  • On why reducing hesitancy is more difficult in the later stages of vaccine rollout: “We’re at that point right now where every vaccine is harder to administer, because you’re probably trying to entice a consumer who is more reluctant to take the vaccine or finds it less accessible for a variety of reasons.”
  • On the recent rise in cases in younger populations returning to school: “Studies have looked at what are the most effective interventions—keeping kids in defined social pods within the school so you’re not having the entire grade commingling...and also implementing routine testing of asymptomatic children, ideally twice a week.”

Dr. Kevin Ban explained Walgreens’ decision to mandate vaccination for some employees, what has been working to increase vaccination, and the potential hurdles of administering booster shots.

  • On Walgreens’ thought process behind implementing an employee vaccine mandate: “Collectively as a group, we have followed the science since the beginning of this epidemic. And along with the effectiveness of these vaccines, we’ve noted the safety. And so collectively, as a leadership team, we thought that the right thing to do here was to, in fact, mandate vaccines.”
  • On the effectiveness of local outreach in vaccination efforts: “Meeting people where they are and listening to them and trying to understand what is it that’s preventing you, and then addressing that, is powerful. It’s hard to do across the country, but you can do it locally.”

In a final Why It Matters segment, Axios' Caitlin Owens and Tina Reed echoed similar curiosities about the impending rollout of booster shots, and raised the question of how the process may mirror or differ from that of the initial vaccine distribution.

Tune in next month for October's Vitals Check-Up.

The startup that wants to disrupt big internet providers

Maura Losch/Axios

A new startup backed by funding from AOL founder Steve Case and Laurene Powell Jobs wants to break up broadband monopolies across the country.

Why it matters: Internet access has been crucial during the pandemic, but it's not ubiquitous, and it can be both slow and unaffordable in swaths of the country.