Thank you for the opportunity to speak today. My name is Dr. Laura Gottschalk from the National Center for Health Research. Our research center analyzes scientific and medical data and provides objective health information to patients, providers and policy makers.
The need for new antibiotics has become increasingly dire, and new incentives are needed to encourage the development of new drugs and screening tools to quickly diagnose and then treat drug-resistant infections. But we’re worried that previous efforts have practically ignored the key goal is not to develop new drugs, but rather to ensure improved health outcomes and safety of patients facing multi-drug resistant infections.
It is impossible to improve patient outcomes if FDA approves new antibiotics based on in vitro results and surrogate endpoints instead of studies of patients with resistant bacteria.
The other problem is that current law allows antibiotics to be approved for a small, targeted group of patients but then allows companies to widely promote those antibiotics for use by as many patients as possible.
Of 61 new antibiotics approved between 1980-2009, 43% were later withdrawn in part due to safety or efficacy reasons. This rate is about 3 times as often as the 13% of non-antibiotics drugs approved over the same time period.
This demonstrates that widespread use of new antibiotics could pose risks for patients receiving them, while also increasing the risk of developing resistant pathogens. A reminder of the possible safety risks from antibiotics occurred last month when the FDA issued a new warning about disabling side effects that can occur from taking fluoroquinolone antibiotics.
We’re not convinced that strategies to encourage the private sector to solve this problem make sense, because there is an inherent conflict between a company’s investment to develop new antibiotics for targeted populations and the public health need to prevent wide-spread use of those drugs. And patent extensions and other financial incentives will always mean that the American taxpayer will be footing the bill anyway. We agree with Rep. Jan Schakowsky that this is an issue where the government needs to step in. In our view, it is time for the NIH to invest in this work instead, and thereby put limits on off label promotions that lead to overuse.
Thank you for consideration of our comments.