Dear All:
You are doubtless now familiar with all the reasons why we need pull incentives for AMR-related products (as background, see this blog). We don’t yet have anything beyond the US GAIN act and it alone will not suffice.
In the US, there are discussions this week in the House of Representatives on reauthorizing PAHPA, the Pandemic and All-Hazards Preparedness Reauthorization Act. Language about market entry rewards (specifically, Transferable Conveyance Awards, TCAs, the new language for transferable exclusivity vouchers) has been in and out of the revised Act, but is currently NOT included.
Although TCAs are not perfect, they appear to be the best way for the US to implement something that approximates the idea of a Market Entry Reward (MER) that was proposed by DRIVE-AB for AMR-related products. If implemented with suitable care, it seems obvious that you could use a TCA to provide the type of delinked payments that are at the heart of the MER idea. If you agree with this viewpoint, today would be a really good day for you (or your company’s CEO) to send a note (separately) to any or all of the the staffers working for these representatives:
- Rep. Doris Matsui (D-CA): megan.herber@mail.house.gov
- Rep. Anna Eshoo (D-CA): rachel.fybel@mail.house.gov
- Rep. Tony Cardenas (D-CA): Jacqueline.Usyk@mail.house.gov
- Rep. Diane DeGette (D-CO): michelle.greenhalgh@mail.house.gov
- Rep. Brett Guthrie (R-KY): sophie.trainor@mail.house.gov
- Rep .Leonard Lance (R-NJ): Robert.Butora@mail.house.gov
- Rep. Chris Collins (R-NY): charlotte.pineda@mail.house.gov
- Rep. Marsha Blackburn (R-TN): meghan.stringer@mail.house.gov
David Shlaes has posted a good set of talking points on his Perfect Storm blog. You could use those ideas as well as the materials cited above to help you write a brief message regarding your work in this area, your geography (if relevant to the given Representative), your concern about the negative economics of work in this area, and the value that a Pull incentive such as the TCA would have for you or your company would be appropriate.
Separately, see the Upcoming Meetings list … a detailed summary from last summer’s NIAID PK-PD workshop has now been published.
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:
- [OLD MEETING, detailed summary now out] 14-15 Jun 2017: NIAID PK-PD workshop. A detailed summary document is now available. See also my prior blog on this meeting.
- 4-7 Jun 2018 (Boston): BIO. The anti-infective track includes sessions that cover bacteria, fungi, viruses (Ebola, Influenza), and vaccines. Note especially the session at 11a on 6 June entitled “The value of addressing AMR” with speakers Colm Leonard (NICE) and Mark Sculpher (EEPRU at York) as well as the session at 4p on 4 June entitled “Forging antimicrobial R&D pacts”.
- 7-11 Jun 2018 (Atlanta): ASM Microbe
- 8 June 2018 (Atlanta): Antibiotic R&D Networking Event hosted by Pew Trusts and GARDP. Venue details and registration are here.
- 12-13 Jun 2018 (Washington): National Academies of Science workshop: Understanding the Economics of Microbial Threats
- 13 June 2018 (webinar, 5-6.30p CEST): The first of a series of GARDP+CARB-Xed webinars on development: Antibacterial drugs: clinical development for non-developers Part 1: Traditional development – tiers A and B
- 14 June 2018 (Washington): Duke-Margolis & FDA event: (link to register) “Understanding the Development Challenges Associated with Emerging Non-Traditional Antibiotics”
- 21-22 Jun 2018 (London): joint EMA-FDA-PMDA workshop on pediatric development of antibacterial agents.
- 22-26 Jun 2018 (Saskatoon, Canada): 5th International One Health Congress, including a dedicated AMR track
- 26 June 2018 (CDD-sponsored webinar at 11a EST): “SAR data in Drug Discovery”. Andrew Leach (ChEMBL) and Evan Bolton (PubChem) will discuss drug discovery informatics and ways to use the freely available PubChem and ChEMBL SAR data.
- 22-27 Jul 2018 (Bryant University, Smithfield, RI): Gordon Research Conference on Drug Resistance for Cancer, Infectious Disease and Agriculture
- 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”
- [UPDATED with full program] 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
