As a physician, I have seen firsthand the need for better tools to fight infections. Many infections are caused by bacteria that can be treated with antibiotics but unfortunately, these bacteria can also evolve to become resistant to the effects of these drugs. More judicious use of antibiotics in health care and agriculture settings can help slow the rate at which bacteria become resistant to antibiotics. But even with prudent use, we need new antibiotics to combat this growing public health problem.
Discovering a new drug is hard. And antibiotic development faces even greater economic and scientific challenges. If researchers, through a highly novel mechanism, create a new antibiotic drug that works against resistant bugs, doctors could seek to hold such a medicine in reserve, using it sparingly so that bacteria do not become resistant to its effects. But by limiting a drug’s use, we also limit its economic returns. This can reduce some of the incentive to develop such a drug in the first place.
Finding new treatments
Much of the Food & Drug Administration’s [FDA] work focuses on encouraging the development of new antibiotics to treat serious infections like pneumonia, kidney infections and tuberculosis. For some patients, antibiotic resistance has rendered many of the existing treatments for these infections ineffective, making them even more difficult to treat. To address these challenges, the FDA has engaged with physicians, scientists, industry and patient advocates through workshops and public meetings to seek new opportunities for developing new antibiotics, especially for patients who have few or no existing treatment options.
In order to get new treatment options to patients more quickly, the FDA and key stakeholders have worked together on improving our approach to antibiotic clinical trials. The goal is to improve the efficiency of the development process as well as our ability to properly characterize the benefits and risks of a new drug before it is prescribed to patients. In order to avoid patients using antibiotics that are less effective for their infection, which can increase the risks of bacterial resistance, it is very important to identify which drugs work well in which type of infections, and which drugs do not work as effectively.
Seeing progress
This work has paid off with eight new antibiotic drug approvals over the last four years. While progress has been made, the pipeline of new antibiotic drugs is still limited. At the same time, resistance continues to chip away at the usefulness of treatments that we have relied on for years. New therapeutic options are needed to keep pace with these challenges.
At FDA, we are committed to continuing the engagement with stakeholders to accelerate the pathway for innovative approaches to making new, more effective antibiotics available. In the meantime, we can all play a role by carefully considering our treatment decisions in order to reduce antibiotic resistance.
