Friday, November 20, 2009

The FDA - another blow to antibiotics?

More and more pharmaceutical companies are abandoning the field of antibiotics research. The markets are marginal compared to treatment of chronic conditions like high cholesterol or chronic depression. The discovery of new antibiotics is getting harder. In recent years, the FDA has released a series of guidelines requiring trials for market approval in various areas of antibiotic development that simply cannot be carried out. The latest set involves the treatment of pneumonia. The release of these guidelines requires enormous work on the part of FDA staffers. But the guidelines as they currently stand, at least for antibiotics taken in pill form, require studies that simply cannot be performed. Why would the FDA require clinical trials that cannot be done? Do they not understand that the proposed design is infeasible? Was it done for political reasons?
Regardless of the reason, if the trial cannot be performed, no new such antibiotics will be developed. The number of infections where the market remains attractive and where industry can still actually carry out the trials required for licensure of a new antibiotic are rapidly dwindling. This will only accelerate the abandonment of this area of research. Without antibiotic research we won't have any new ones. This is all occurring at a time when we desperately need new antibiotics. Antibiotic resistance is rising to the point where for many infections, we no longer have effective antibiotics.

The FDA and its advisory committee are set to review the draft pneumonia guidelines on December 9. Some, like Public Citizen, have proposed even more stringent trial designs that are even less feasible than those already included in the current draft guidelines.

The system is broken. Is this an opportunity to move forward, or will we be forced to take yet another giant leap backwards?