She Speaks!

Hey everyone – I just received my copies of my book as promised by Springer. I think I’ll put them in a safe deposit box. 

But to business.  I have seen a flurry of activity by Dr. Hamburg, Commissioner of the FDA that is relevant to Antibiotics – the Perfect Storm.   And my spies tell me that Dr. Temple has been active as well. Since I am not a journalist, and do not cover Dr. Hamburg’s speaking engagements, and since I am not involved in the FNIH process or other direct interactions with Dr. Temple (outside of the usually advisory committee meetings and public workshops), I have to rely on spies and news reports.  Nevertheless, a story is emerging.

Two recent new reports have reported on Dr. Hamburg’s statements on antibiotic resistance and the antibiotic pipeline.  According to Alicia Mundy of the Wall Street Journal, at a recent appearance at the National Press Club, Dr. Hamburg noted the increasing resistance to available antibiotics.  She laid this at the feet of antibiotic use both for human health and for crops and in chickens and livestock. She called for more judicious antibiotic use.  This comes at a time when the FDA is (finally) poised to act on the use of antibiotics in agriculture. But, according to Mundy, Dr. Hamburg also said that the state of the antibiotic pipeline is “distressingly low” and that “the range of antibiotics is disturbingly limited.” 

It is comforting to know that Dr. Hamburg is at least devoting some of her time and energy to antibiotics.  I know from my days on the Institute of Medicine’s Forum on Emerging Infections, where she was a frequent participant and co-chairman, and from Dr. Hamburg’s history in New York during the outbreak of resistant TB in the 1990s, that she is acutely aware of the issues of antibiotic resistance. I admit that I have been worried (and am still not reassured) that Dr. Hamburg would be so overwhelmed with crisis management within a large and unwieldy bureaucracy that she would have no time to think about the antibiotic mess at the FDA. 

Evidence that FDA management is beginning to get more involved comes from spies.  Apparently Dr. Robert Temple has harkened back to Mark Goldberger’s (ex-Director of the antibiotics division at FDA) suggestion from 2002 that we approve antibiotics based on a small number of high quality cases.  That is, we recruit patients with serious disease caused by resistant pathogens that would be untreated or poorly treated with approved antibiotics, treat them with a new drug showing that it works (is superior).  The devil here, as it was back in 2002, is in the details.  Which infections are OK?  Is bacteremia from any source OK?  The FDA has rejected that approach many times over the years.  Is hospital-acquired pneumonia OK?  If so – what kind of difference would the new drug have to show?  How many patients would that require? How many patients would have to be studied? 10?  20? Hundreds?  Are historical controls OK?  If so in theory, how would you justify the treatment effect for the historical controls?  If historical controls are not OK, is it ethical to not treat patients with a drug that will, with a greater than 50% or even 80% probability, work?  At least, maybe, we are back to considering these approaches at top levels within the FDA.  The basic question remains – can we make anything happen that will speed approval of needed new antibiotics?

The other piece of news, Angie Drakulich reports in PharmTech.com that The FDA and generic drug manufacturers are discussing user fees to speed approval of new generics.  This would allow the FDA to carry out a timely review of generic drug safety and manufacturing standards according to the FDA.  As those of you who have been following my blog know, generic antibiotics has become one of my key issues since the Ketek scandal.  During the Ketek scandal, it was clear that many generic drugs were approved for use in otitis, sinusitis and acute bacterial exacerbations of chronic obstructive pulmonary disease.  But they were approved based on clinical trials that the agency now considers to be obsolete and invalid. At the same time, several of these generic drugs have safety problems.  At the time, I asked the FDA to review these generics and either remove their approvals for these indications or at least change their labels.  Nothing has happened in the last four years.  Maybe user fees will allow the FDA to actually work on this problem.

When it comes to the FDA, I am no longer ever optimistic.  But I am heartened to see that the eye of top management has, at least, been drawn to the very serious problem of rising antibiotic resistance coupled with our shrinking antibiotic pipeline.