Tuesday, November 29, 2016
The 21st Century Cures Act and Antibiotics
It looks like congress is finally going to pass the 21st Century Cures Act. Its 996 pages long! Please read it yourself (just kidding). Of course, this doesn’t even come close to France’s labor laws at 3500 pages – but its still impressive. The bill contains over $6 billion in funding most of which will go to NIH for work on opioid addiction, cancer and Alzheimer’s disease. There is no doubt that the NIH needs more money since funding has been flat for years – therefore, corrected for inflation – we’re on a downward spiral. But targeted funding like this tends to take money and attention away from other areas of need – like antibiotic research for example.
So – what’s in it that’s good for antibiotics? Lots!
Limited Population Antibiotic Development (LPAD). There is a clear pathway spelled out for the FDA on antibiotics for use in limited populations where approval is based on smaller data sets than would normally be expected. Of course, we all know that the FDA is already doing this under existing regulations – but this puts Congress on record as supporting this approach. The FDA apparently thinks that this law will help them do more to bring new antibiotics to market quicker – and if the FDA thinks this will help then so do I. (OK – I changed my tune . . .). The best example of what the FDA can do is their approval of cetazidime-avibactam based mainly only on phase II data. Hopefully, more drugs can now be approved more quickly in this way. One also hopes that pathways will now appear for the rapid approval of pathogen-specific antibiotics (see my last blog on this).
Novel Clinical Trial Designs. The Secretary HHS is ordered to convene a public meeting providing input to the kinds of novel clinical trial designs and statistical methods that would be required to implement LPAD. This would then be followed by guidance from FDA in this regard. I suspect this is already in the works and the infectious disease group has already held public meetings on this.
The role of BARDA is clarified and expanded. But BARDA probably still does not have the funding to provide a business model for pathogen-specific antibiotics.
Antimicrobial susceptibility testing. The FDA is ordered to establish a website with interpretive criteria for susceptibility testing that will be frequently updated and that will start upon approval for each newly approved drug. The FDA will have the authority to rely on outside organizations for help here – similar to the way this works in Europe. I don’t see anything here that will speed the availability of automated testing to laboratories and physicians in the US. This is still desperately needed and I don’t see a way forward here as yet. The most important aspect of this part of the Act appears to be the updating of information on already marketed antibiotics. But that, in and of itself, is a major advance.
Breakthrough Diagnostics. There is a section on the rapid development and approval of new diagnostic devices. This is an important section that might make it more feasible to bring new rapid diagnostic testing devices to the US market. We have been way behind Europe in this regard.
Recruitment and Retention at FDA. There is an entire section spelling out the skills that will be required for new hires in the clinical review roles at FDA. This includes provisions for justifying higher salaries and other areas that would allow more efficient recruitment and better retention of FDA employees. This is obviously needed based on what I have been reading. I didn’t see anything there specifically on conflicts of interest and making exceptions although the Secretary of HHS is to report back to congress as to needs in this area. There is also nothing related to getting more expertise on advisory panels by waiving some conflict of interest criteria.
As I noted, there are obvious areas where the bill could still be improved. Hopefully the bill will pass without amendments to defund Planned Parenthood for example.
My congratulations and thanks to Pew Charitable Trust and to the Infectious Diseases Society of America for their tireless efforts to get this passed over the last 3-4 years.
But, at the end of the day, until we have a business model that works for antibiotics, our pipeline will remain dry in spite of this legislation.