Incentives to stimulate the development of new antibacterial drugs in human medicine
Policymakers should strongly consider the establishment of significant incentives to stimulate antibacterial drug development
Research to support the development of new antibacterials
Increase communication between US and EU research agencies to identify common scientific challenges that may represent opportunities for collaboration
Publicise funding opportunities to EU, US research communities
Regulatory approaches for antibacterial products
FDA and EMA intend to discuss ways to facilitate the use of the same clinical development programme to satisfy regulatory submissions to both Agencies
Establish regular meetings between FDA and EMA to discuss common issues in antibacterial drug development and regulation
Exchange information on possible approaches to drug development for bacterial diseases where limited drugs are available
Friday, February 3, 2012
Another Taskforce Bites the Dust!
I don’t know how I missed this, but the Transatlantic Taskforce on Antimicrobial Resistance published its long-awaited report in September last year. I was disappointed but not surprised. I have been involved in a number of such efforts going back to the mid-1980s. Back then a number of us engaged in research on antimicrobial resistance began to suscpect that there was an active bias against funding such research within NIH. We carried out an investigation of the previous 25 years or so of funding and found that the record of NIH funding for such research was absolutely appalling. We suggested as a key step forward that the NIH establish a new study section peopled with experts capable of reviewing grant applications in this area. In 2006, 20 years after our original suggestion, they did just that. And that was the most successful such effort in which I have participated.
In the early 1990s, the US government established an interagency taskforce on antimicrobial resistance. I was a member of the first group of advisors for this taskforce. At the time, I was very concerned about the US research agenda. Virtually all of the recommendations from our section were ignored.
In 1994, the ASM convened a similar taskforce in which I also participated. This report called for more funding for surveillance and for more research to better understand the role of antibiotics used in farming and aquaculture. While some of the recommendations were followed to one extent or another, basic research on antimicrobial resistance in the US still had to await the formation of the new study section for the NIH in 2006.
For seven years I participated in the Forum on Emerging Infections at the national Academy of Science led by Josh Lederberg following his landmark book on emerging infections. During those years, I tried to focus on the impending disaster in our antibiotic pipeline. 1999 saw the first of the large pharmaceutical companies to abandon the area of antibiotic R&D and the continuing consolidation with the industry was also taking its toll. My own focus became more and more the regulatory environment in the US. In 2001, an entire chapter in the Forum’s report on Biological Threats and Terrorism was devoted to this topic. And where are we with US regulation for antibiotics and biothreats today?
The report from the transatlantic taskforce is disappointing but for a different reason. It’s recommendations regarding strategies for improving the pipeline aside from the discussion on incentives are so weak as to be inconsequential. With a report like this, we are going nowhere. The key recommendations from improving the pipeline are as follows:
For the FDA and EMA to exchange information and establish regular meetings – come one! What outcomes are desired from these exchanges that will impact our pipeline?
I’m sorry – but I guess my expectations for this taskforce, as low as they were, were still too high.