Yesterday, the U.S. House of Representatives passed the 21st Century Cures Act, which will address the worldwide antibiotic resistance crisis, as well as the nation’s opioid epidemic and its corresponding surge in HIV and hepatitis C infections.
The Infectious Diseases Society of America (IDSA) commends the House of Representatives for promoting biomedical innovation through passage of the 21st Century Cures Act yesterday. IDSA strongly supports elements of the legislation that address antibiotic resistance and is encouraged to see provisions that support the next generation of scientists. Importantly, the bill also addresses the opioid epidemic that is contributing to a surge in new HIV and hepatitis C infections.
Antibiotic resistance continues to threaten patient safety, public health and national security. The House-passed bill takes an important step to reduce regulatory barriers to antibiotic and antifungal research and development.
We know that the population of individuals who have a specific antibiotic-resistant infection at any given time is relatively small, which makes populating a traditional large-scale clinical trial nearly impossible. For that reason, IDSA has long advocated for a new limited population approval pathway at the FDA for antibiotics and antifungals that treat serious or life-threatening infections with an unmet medical need. The bill permits these smaller and more efficient trials and includes safeguards to guide the appropriate use of the drugs that are developed.
IDSA has also highlighted the need for federal policy to attract and support the next generation of infectious diseases physician-scientists. We are pleased that Cures includes the creation of a Next Generation Researchers Initiative within the National Institutes of Health (NIH). We also believe that the increase in the NIH loan repayment annual maximum from $35,000 to $50,000 is a meaningful step towards making research careers more feasible.
Additional policy solutions will be required to address antibiotic resistance, bolster the scientific workforce and combat new and emerging threats. However, IDSA believes that the Cures Act represents a considerable life-saving step forward. We urge the Senate and President Obama to approve the legislation.