Government Action

Updates from EMA, FDA, and UK NICE at the 6-8 Sep 2017 ASM-ESCMID Antibiotic Development Conference

Dear All: On Wednesday 6 Sep at the ASM-ESCMID Conference on Antibacterial Development, we heard 3 superb back-to-back talks on the evolving regulatory and health technology assessment (HTA) landscape. The speakers (Marco Cavaleri, PhD, Head of Anti-Infectives and Vaccines, EMA; Sumati Nambiar, MD, Director, Division of Anti-infective Products, FDA; and Colm Leonard, MD, Consultant Clinical Adviser,

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PASTEUR Act re-introduced and levels up antimicrobial economics for strong innovation!

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Woot, woot! Woot, woot! US Senators Michael Bennet (D-Colo.) and Todd Young (R-Ind.) and Representatives Mike Doyle (D-Pa.) and Drew Ferguson (R-Ga.) have today reintroduced the PASTEUR (Pioneering Antimicrobial Subscriptions to End Up surging Resistance) Act! Here are the links you need: The text of

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G7 Health ministers 3-4 June communique / Implications for choosing wisely

Note: Newsletter now updated to include the communique from the G7 Finance Ministers! Dear All, The G7 met in Oxford this past week and we now have communiques released from by both the Health and Finance Ministers. Let’s look first at the two fascinating statements from the Health Ministers: A general communique that includes multiple

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Ex-US new antibiotic access: Multi-year delays, even in Europe!

Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Post-newsletter addendum: A slide deck that summarizes the data from the paper is now available. We talked in a 22 Mar 2021 newsletter about ensuring access to new antibiotics and you should take a moment to refresh your memory of its discussions of

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G7 Finance Ministers call for Pull; US-specific text cites PASTEUR and a PASTEUR backup plan!

https://www.youtube.com/watch?v=f0-xt3FrAGU&ab_channel=AMR.SolutionswithDr.JohnRex Dear All, VERY exciting news on the Pull incentive front: The G7 Finance Ministers have released a statement on Actions to Support Antibiotic Development, aiming to strengthen G7 preparedness against the “silent pandemic” of antimicrobial resistance. Implicitly, this is a statement that is agreed and endorsed by the political leadership of each country —

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Updated ATMF AMR Benchmark! Signs of progress but access lags

Dear All (and with thanks to ATMF’s Damiano de Felice for co-authoring this newsletter), Last week, the team at ATMF (Access to Medicine Foundation) released a 3rd update to the AMR Benchmark series that they started in 2018. For those not familiar with the ATMF, its independent analyses (all its funding is from governments or private

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WHO Essential Medicines List (EML): Antibiotic Book promotes AWaReness

Dear All, WHO have released for consultation an updated draft of their EML (Essential Medicines List) Antibiotic handbook. For those not familiar with it, WHO’s EML (now in its 22nd edition!) provides a guide to a core set of medicines that every country should have. The antibiotic-focused version does this for antibiotics and then adds

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