NCHR Testimony to the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria

Thank you for the opportunity to speak today. My name is Dr. Stephanie Fox-Rawlings from the National Center for Health Research. Our center analyzes scientific and medical data to provide objective health information to patients, providers and policy makers.

Development of new antibiotics will only help if they actually improve the health of patients with resistant infections. This is not possible when new drugs are not as safe and effective as antibiotics already on the market or when they are not studied on patients with resistant bacteria.

The FDA often relies on non-inferiority trials for antibiotics, which can result in drugs that are somewhat less effective than an approved version. After several rounds of comparing new drugs to somewhat older drugs that were slightly less effective than previously approved drugs, we can end up with new antibiotics that are much less effective than the best available. Furthermore, if they are chemically similar, the new drug adds to rather than reduces the problem of antibiotic resistance.

Unfortunately, the 21st Century Cures Act could easily increase the number of antibiotics that do not benefit patients.  This is already a problem. FDA’s efforts to speed up drug approvals have led to relatively high rates of antibiotics later removed from the market because they were not effective. The smaller clinical trials for limited populations recommended in Cures could make this worse because this increases the risk that results are due to chance.

Because researchers lack tools to quickly diagnose patients with resistant bacteria, these small studies include patients who do NOT have resistant bacteria.  And once approved, the new drugs are often promoted and prescribed for a wider patient population than included in trials. This can expose patients to unnecessary risks, lower effectiveness, and generate resistant bacteria.

Prevention and control requires methods to make sure antibiotics work on resistant bacteria and are limited to those cases. This includes development of rapid testing options for researchers to determine which antibiotics are most effective and for healthcare and veterinary practitioners to ensure that antibiotics are targeted for approved uses.