Now, I am delighted to report that a really serious effort is underway in the US to make something happen during the 116th Congress.
The essential document can be found here. This is a letter that has been sent with appropriate adjustments to all the relevant legislative committees: the Senate Committee on Health, Education, Labor & Pensions (HELP), the Senate Committee on Finance, the House Committee on Ways & Means, and the House Committee on Energy & Commerce.
After explaining the background and the need for a fundamental fix via a package of incentives, the letter reads as follows:
“Key principles of a pull incentive package:
- Incentives should be paid after FDA approval, rewarding only successful development of novel antibiotics that address the greatest public health need.
- A package of incentives should aim both to stabilize today’s novel antibiotic market and to ensure the viability of future development – meaning they must be substantial and viewed as highly valuable to private markets.
- Economic incentives should provide predictability for drug developers – assurance that the company can commit R&D funds today, knowing that the economic incentive will be available if the new drug meets eligibility criteria.
- Incentives must be aligned with appropriate antibiotic stewardship and surveillance.
“We commit to working with Congress and the Administration to further develop and advance a package of antibiotic incentives, at least some of which must be enacted in 2019 to meet growing patient needs and help mitigate a public health crisis. Such a package could, for example, include a mix of tax incentives, novel pull incentives, reimbursement changes, and even a low-interest loan program, along with continued investment in NIAID and BARDA.”
The letter is signed by a very broad coalition of stakeholders who are now working closely together:
- Antimicrobial Innovation Alliance
- Antimicrobials Working Group – (Amplyx Pharmaceuticals, Aridis Pharmaceuticals, Cidara Therapeutics Inc., ContraFect Corporation, Entasis Therapeutics Inc., Iterum Therapeutics Ltd., Melinta Therapeutics Inc., Motif Bio plc, Nabriva Therapeutics US Inc., Paratek Pharmaceuticals Inc., Qpex Biopharma Inc., SCYNEXIS Inc., Summit Therapeutics plc and VenatoRx Pharmaceuticals Inc.)
- Biotechnology Innovation Organization
- Infectious Diseases Society of America
- Pfizer Inc.
- Shionogi Inc.
- Spero Therapeutics
- Tetraphase Pharmaceuticals
- The Pew Charitable Trusts
- Trust for America’s Health
There is active progress even now on a bipartisan bill that would be introduced to the House and Senate simultaneously in which a fundamental DRG fix is proposed as an initial step. In parallel, we are going to seek to explain and develop support for a delinked reward model to follow the initial DRG-focused fix.
Cross your fingers!
Now is the time for all people of good will to support this effort, with time, energy and money. We can’t afford to wait until the 117th or 120th Congress!.
If we fail, it won’t be for lack of trying. And if your company wants to join in, please let me know and I’ll connect you appropriately.
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: http://amr.solutions/blog/
Upcoming meetings of interest to the AMR community:
- 7 Feb 2019 (London): Opportunity to comment in person on the IACG draft recommendations. See this tweet for more details.
- 21 Feb 2019 (everywhere, 17:00-18:30 CET): GARDP-sponsored webinar entitled “NIAID Resources to Facilitate Discovery & Development of Anti-Infectives.” Register here.
- 5-6 Mar 2019 (Washington): NIAID-sponsored workshop: Vaccine strategies for endemic fungal pathogens. Register here.
- 14-15 Mar 2019 (Berlin): BEAM-, Novo REPAIR-, CARB-X-, DZIF-, ND4BB-ENABLE-sponsored (among a long list!) Berlin Conference on Novel Antimicrobials and AMR Diagnostics. Details here. Poster submissions are being accepted through 9 Jan (details here).
- 18 Mar 2019 (everywhere): Deadline for responding to the WHO call for data on preclinical antibiotic programs. Details here.
- 21-22 Mar 2019 (Birmingham, UK): BSAC Spring Conference.
- 26 Mar 2019 (London, UK): Sponsored by The Economist, a 1-day symposium entitled “Antimicrobial Resistance: Preventing an antibiotic apocalypse.” Register here.
- 28 Mar 2019 (everywhere, 4-5.30p GMT): GARDP-sponsored webinar entitled “Clinical development for non-developers Part 3: Antibacterial Drug Enhancer Combinations and Non-traditional Products.” Register here.
- 11-12 Apr 2019 (Amsterdam): ESGAP–SWAB (European Study Group for Antibiotic Policies – Stichting Werkgroep Antibioticabeleid) Technical Workshop on measuring quantity and quality of antimicrobial use. Register here.
- 13-16 Apr 2019 (Amsterdam): Annual ECCMID meeting
- 16-18 Apr 2019 (Utrecht): ICOHAR, International Conference on One Health Antimicrobial Resistance. Organized by the ESCMID Study Group for Veterinary Microbiology (ESGVM).
- 24-26 Apr 2019 (Boston): Annual SHEA (Soc. for Hospital Epidemiology of America) Spring meeting
- 6-11 May 2019 (Ljubljana, Slovenia): 37th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Details here.
- 3-6 Jun 2019 (Philadelphia): Annual BIO meeting
- 10-11 June 2019 (Research Triangle Park, NC): AMR Action Summit on R&D and Commercialization. Sponsors include the British-American Business Council, the UK Gov’t, CARB-X, the NC Biotechnology Center, and others. Details here.
- 20-24 June 2019 (San Francisco): Annual ASM Microbe meeting.
- [Mark your calendar now!] 3-6 Sep 2019 (Boston). Annual ASM-ESCMID Conference on Antibiotic Development. The Bootcamp series will continue on 3 Sep with the main meeting on 4-6 Sep. Mark your calendar now and check back here for details.
- 6-8 Sep 2019 (Bilbao, Spain): 5th ESCMID conference on Vaccines. Check back here for details.
- 2-6 Oct 2019 (Washington, DC): IDSA’s annual IDWeek meeting.
- 19-27 Oct 2019 (Annecy, France): International Course on Antibiotics and Resistance (ICARe) – A soup-to-nuts intensive residential training program on all things AMR, especially R&D for new antibiotics. See this link for details.
- [Mark your calendar now!] 1-6 Mar 2020 (Il Ciocco, Tuscany, Italy): GRC on Antibacterial Discovery and Development: “Now is the time to re-boot antibiotic R&D before it’s too little, too late.” Not yet online, but the date is firm. Will share a link when it becomes available.