Dear All:
Incredibly exciting news! Due to the bipartisan efforts of Representatives John Shimkus (R-IL) and Tony Cardenas (D-CA), the Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 is now being introduced. This is the Pull incentive that we’ve been looking for in the US!
The very short summary is that REVAMP (a) creates a new “priority antimicrobial product” category, (b) grants a transferable conveyance award of 12 months of additional exclusivity upon registration of such a product that (c) can be applied in whole or in pieces to extend the exclusivity of another product and that (d) is balanced by inclusion of provisions covering stewardship, creation of susceptibility testing devices, and education.
There are some other rules in this draft (5% of the generated funds must be returned to support antimicrobial R&D and the process must be re-authorized after every 10th product), so please read the bill yourself:
- REVAMP, the draft bill as of 28 June 2018
- A summary of REVAMP
- A commentary on the need for REVAMP
- A press release on REVAMP from the Antibiotic Innovation Alliance
- And as a bonus, Kevin Outterson has assembled this excellent bibliography of all things Pull
It is my understanding that the legislative world is at a pause between now and 4 July but that soon after that it will be time for another letter-writing campaign. I’ll send another newsletter late next week suggesting ways you could choose to proceed.
In the interval, please take a look at these materials and get ready to lend your support to this exciting and important effort. This is such an important step for our community — we really need this to happen!
All best wishes, –jr
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://13.43.35.2/blog/
Upcoming meetings of interest to the AMR community:
- 22-27 Jul 2018 (Bryant University, Smithfield, RI): Gordon Research Conference on Drug Resistance for Cancer, Infectious Disease and Agriculture
- 7-8 Aug 2018: A pair of FDA Advisory Committees:
- 7 Aug: Amikacin liposome inhalation suspension (ALIS) from Insmed for lung disease caused by Mycobacterium avium complex (MAC)
- 8 Aug: Paratek’s Omadacycline for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infection (ABSSSI).
- 21-22 Aug 2018 (FDA White Oak Campus, Silver Spring, MD): workshop entitled “Development of Non-Traditional Therapies for Bacterial Infections”. Meeting notice is here.
- 21-22 Aug 2018 (Rockville, MD): NIAID-NINDS-DTRA workshop entitled “Infectious Disease in The CNS and Therapeutic Strategies to Cross the Blood-Brain Barrier”
- 21-23 Aug 2018 (Cardiff, UK): BSAC Standardized Susceptibility Testing Residential Workshop. Register here.
- [Don’t miss this one!] 4-7 Sep 2018 ESCMID-ASM Conference (#3) on Drug Development for AMR (Lisbon, Portugal). Full program is now posted.
- 24-28 Sep 2018 (Big Sky, Montana): MSG-ERC (Mycoses Study Group) Biennal meeting
- 3-7 Oct 2018 (San Francisco): ID Week
- 6-14 Oct 2018 International Course on Antibiotics and Resistance (ICARe, Les Pensières, Annecy, France)
- 26 Oct 2018 (London): EMA information day for SMEs: “Regulatory toolbox for medicines and combined devices developers”. Here is the current agenda. Webcast will be available. More details from sme@ema.europa.eu.
- 7-9 Nov 2018 (Seville, Spain): Better Methods for Clinical Studies in Infectious Diseases and Clinical Microbiology: A Hands-on Workshop
