Every year in the United States, 2 million people acquire an antibiotic-resistant infection. Of those, at least 23,000 die as a result. That’s according to an alarming report released last week by the CDC. Antibiotic resistance is one of the largest threats to global health. The prevalence of antibiotic-resistant infections is not only a serious world-wide public health issue, it also adds considerable costs to the U.S. healthcare system. According to the CDC:
Studies have estimated that, in the United States, antibiotic resistance adds $20 billion in excess direct health care costs, with additional costs to society for lost productivity as high as $35 billion a year. The use of antibiotics is the single most important factor leading to antibiotic resistance. Up to 50 percent of all the antibiotics prescribed for people are not needed or are not prescribed appropriately.
The CDC has identified four core ways to fight back against this growing threat:
- Preventing infections
- Tracking data on resistant infections
- Improving antibiotic use/stewardship
- Developing new drugs and diagnostics
With only 9 new antibiotics approved in the last 15 years, more needs to be done to incentivize the development of new and novel antibiotics. With this in mind, just last year Congress passed, and the President signed into law, the FDA Safety and Innovation Act (FDASIA) which included provisions specifically designed to increase investment in the research and development of antibiotics, the Generating Antibiotic Incentives Now (GAIN) Act. Specifically, the new law provides for priority FDA review and an additional 5 years of exclusivity for “qualified infectious disease products”.
Given the importance of this issue, as underscored by the CDC report, we’ve decided to hold a workshop on the GAIN Act at our upcoming BIO Investor Forum taking place Oct. 8-9 in San Francisco. This panel will explore how those incentives work and discuss how and if they will spur development of antibiotics. Additionally, the panel will discuss new approval pathways being proposed by FDA, Congress and other stakeholders and how they could jump-start development of new antibiotics and address the rising threat of antibiotic-resistance. To register for the BIO Investor Forum, please visit here.