Antibiotics: FDA Has Encouraged Development, but Needs to Clarify the Role of Draft Guidance and Develop Qualified Infectious Disease Product Guidance, GAO-17-189: Published: Jan 31, 2017. Publicly Released: Mar 2, 2017.
“Each year, over 2 million Americans get sick from bacterial infections that are resistant to antibiotics, and at least 23,000 die as a result. There has also been a steady decline in the development of new antibiotics since the 1980s—raising concerns that there may not be enough new antibiotics to replace those that have become ineffective. In response, the FDA has encouraged drug companies to develop new antibiotics through incentives, such as expediting its review of these drug applications. However, we found that drug companies needed more information on how to use these incentives—and recommended that the FDA provide this guidance…”