US Senate takes on the Superbugs
Today the Senate introduced S.1734 – “A bill to provide incentives for the development of qualified infectious disease products,” which would provide balanced incentives for antibiotic research and development.
This is important because infection-causing bacteria, or Superbugs, are fighting back against the antibiotic therapies that are currently available to doctors and their patients.
At a time when nearly 2 million people get infections while in U.S. hospitals each year and almost 100,000 of them die as a result, the pipeline for new treatments is bleak.
As we explain here, the current regulatory environment is ridden with obstacles for biopharma companies to develop new antibiotics to beat these Superbugs.
The Senate bill mirrors legislation that was introduced in the House earlier this year and addresses regulatory challenges by proposing:
- an extended term of exclusivity for infectious disease products, combined with priority review and fast track provisions
- additional extended exclusivity provided for companion diagnostic tests
- requirements of FDA to provide much-needed guidance on the conduct of clinical trials for antibiotic drugs generally as well as, upon request, specific advice on nonclinical and clinical investigations for individual qualifying pathogens
Congress should do everything it can to pass S.1734. It’s time for the fight against the Superbugs to move beyond our labs and into the hands of doctors who are on the front lines of patient care.