Yesterday, we took Zeke Emanuel s and his New York Times op-ed to task for a variety of reasons.
Today, ACSH advisor David Shlaes, in his blog, Antibiotics-The Perfect Storm, takes a more nuanced look at an alternative way to refill the antibiotic pipeline without dangling big prize money in front of companies that succeed in coming up with a new class of antibiotics (whatever that means).
His idea is simple and smart treat antibiotics like orphan drugs. Shlaes says, I have discussed this, at least indirectly, with both EMA (European Medicines Agency) and FDA in the recent past. Both say that antibiotics are not considered orphan drugs.
He adds, Why might this be important? The answer is that to obtain highly beneficial pricing and reimbursement, especially in Europe, the orphan designation is very helpful.
So, why is this not being implemented? It is because of a complicated set of regulations, which define the necessary parameters for orphan drug status. These could easily be applied to antibiotics that are designed to be used for specific pathogens, which would mean that they would be intended for use in small patient populations exactly what orphan drugs are supposed to do.
Shales explanation is about what you d expect: [W]hoever said that regulatory agencies were internally consistent?
(The EMA guidelines orphan drug designation can be found here.)
Regarding Emanuel s Times op-ed, Shlaes says, I was just surprised to see this article published in the Times as if it were somehow a new idea. This approach and many many other similar approaches have been discussed ad-infinitum for the last six years or so in a large number of US and international forums.
As evidence, he cites a 2009 report published by The London School of Economics and Political Science, which proposed the same idea. And more recently, another report from the Chatham House, discusses ways to minimize the proliferation of bacterial resistance, as well as a different model for ensuring the continued discovery of new antibiotics.
Others have been a bit more blunt in their criticism of Emanuel.
Dr. Henry Miller of the Hoover Institution (and the founding director of the FDA Office of Biotechnology) in his letter to the Times (unpublished), writes, "Dr. Emanuel neglects the role of flawed public policy in discouraging the development of desperately-needed new antibiotics. A 2002 change in F.D.A. requirements for the clinical testing of antibiotics helped to create the shortage of new ones: To enhance the statistical power -- and therefore, the confidence level -- of Phase III antibiotic clinical trials, F.D.A. more than doubled the number of patients required. This made already-difficult clinical trials even more unwieldy and expensive."