We are in desperate need of new antimicrobials to combat the growing threat of drug resistant bacteria. I think the majority of the governments in industrialized nations recognize this threat and are finally starting to mobilize against it. As it currently stands, though, there is little incentive for drug makers to dive into the antibiotic field since there is little return on the investment. The House is seeking to change that.
A newly introduced bipartisan [Reps. John Shimkus (R-IN) and Tony Cardenas (D-CA)] bill would seek to encourage the development of new antimicrobials by offering sponsors an additional 12 months of transferable exclusivity once certain priority antimicrobials are approved.
The exclusivity period is primarily what drug makers use to recoup on investments before medications head to generics, and this bill would allow the exclusivity to be transferred, “meaning the additional 12 months does not have to be applied to the antimicrobial and can be sold.” That’s where the incentive lies.
— Andy Biotech (@AndyBiotech) July 2, 2018
The proposed bill is borne out of the 2016 law, the 21st Century Cares Act, which, “called to combat rising antimicrobial resistance by providing a central, easily accessible and up-to-date repository for antimicrobial susceptibility interpretive criteria, also known as antimicrobial ‘breakpoints.’”
You can follow this Twitter thread to see more analysis of the potential law and why it’s an important incentive for drug makers:
Bipartisan antibiotic pull incentive introduced today in US Congress, REVAMP Act of 2018 (Shimkus-Cardenas) Most important antibiotic legislation in a generation. Text & summary: https://t.co/bwuNKgClru
— Kevin Outterson (@koutterson) June 28, 2018
This is coming at a critical juncture in the CF community. Just yesterday, some of our worst fears were confirmed – nontuberculous mycobacteria (NTM) is spreading through the cystic fibrosis patient population (at least in the UK). An analysis of the UK Cystic Fibrosis Registry found:
The prevalence of individuals with a NTM positive respiratory culture increased every year from 2010 (45 [1.3%]) to 2015 (156 [3.8%])… NTM infection is of increasing prevalence in the UK [pediatric] CF population. This study highlights the urgent need for work to establish effective treatment and prevention strategies for NTM infection in young people with CF.
If it’s happening there, it’s probably happening here too.
Also…side note… this is a tremendous use of Registry data! Hats off to the UK for joining the fight! Shall we recall a few weeks ago when we discussed the importance of registry data in detecting patterns and trends? Not that this was an open access finding, but I think it further proves the point that we should be utilizing patient registries to discover impactful issues across the patient population at large. Why not let patients aid in it?
Ultimately what I’m getting at here is we have a problem and we’re trying to address it. I say, “trying” because we need actionable steps to fight this problem, and we might be getting them!
Guess who will be the first to feel it if we let this problem spiral out of control…
NOW seems like a fantastic time to romanticize the issue, doesn’t it?