An Open Letter to Kathleen Sibelius, Secretary HHS

Dear Madame Secretary Sibelius,

I am writing to you today in desperation. I am convinced that unless the United States follows a path other than its current one, we will face an onslaught of Superbugs with no new antibiotics to fight the battle and protect our citizens. I address my concerns to you in particular because the FDA, working under your aegis, is leading us to an untenable situation and they are not changing course.

I feel like I have tried everything. I have written letters to prestigious medical journals, I speak with the FDA Office of Anti-infectives and Opthalmology on a regular basis, I published a book on the antibiotic problem last year, I write a blog and I speak at various forums. I was a participant in the whitepaper published in 2004 by the Infectious Diseases Society of America entitled Bad Bugs, No Drugs where we warned of the public health threat and suggested a variety of pragmatic approaches to avoid the worst. And I have not been alone in this effort. Yet all this work has been to no avail.

The FDA has listed its accomplishments in antibiotic development in testimony by Dr. Janet Woodcock to Congress last year. They note that they have now published a series of guidance documents clearly laying out a pathway for industry to develop needed antibiotics. Unfortunately, most of those guidances call for a pathway that is quite simply infeasible or irrelevant to the clinicians treating the infections in question. For example, the most recent guidance relates to registering drugs for the treatment of pneumonia acquired in hospitals. This is a very serious infection and there is a desperate need for new antibiotics to treat these infections since many of the bacteria responsible are antibiotic-resistant. But the guidance specifies the size of clinical trials required for registration and this trial size is not achievable in today’s world- or at least not without spending hundreds of millions of dollars and running the trials for 5 years or longer. For an antibiotic that will never earn the return that a drug like Lipitor will, these trials just do not make sense. This seems incredible to me since I know how much time and effort is required for the agency to publish these guidance documents. Why would they promulgate infeasible or irrelevant requirements? The charitable answer is that the FDA is so far removed from both clinical practice and from the industry it regulates that it no longer understands what is feasible and what is not.

While a number of factors contribute to our current lack of antibiotics in the pipeline, the FDA stance is the factor most readily reversed. The FDA roadblock can only serve to further dissuade companies from working in the area. There has been a continual loss of large pharmaceutical companies working in antibiotics. Pfizer is the latest departure. Since large companies are the main resource for small companies to fund expensive late-stage clinical trials, the loss of large companies leads to an investment climate for small companies working on antibiotics that is going from bad to worse.

One of the solutions proposed to the problem has been to provide incentives to both industry and government to discover and develop new antibiotics. But this will be throwing good money after bad if there is no way the new antibiotic can be approved in the US. We might just end up supplementing research that will ultimately benefit other countries but not our own.

The FDA stands alone in the world. With few exceptions, no other countries are following the FDA’s lead here. Notably, the FDA’s sister regulatory agency in Europe has declared that developing antibiotics active against resistant pathogens is their highest priority. The FDA has made no such commitment – quite the opposite it seems.

I am at a loss to explain the FDA’s lurch into Neverland as far as antibiotics are concerned. I can only assume that it is partly a response to political pressure to further distance themselves from industry and to increase their standards for both efficacy and safety. But I consider that a lack of new antibiotics is also a serious safety issue – a fact that the FDA and their congressional critics appear to be ignoring.

In a recent speech entitled, “The FDA and Antibiotics - The Road to Global Irrelevance”, I suggested that we hit the reset button. The FDA needs to start over. Because I believe they are no longer competent to find their way, I ask you, Madame Secretary, to organize a task force reporting to you that will help them recover their bearings. Please let me know if I can be of any help.

Sincerely,

David Shlaes MD PhD

Anti-infectives Consulting, LLC