|21st Century Cures Initiative|
Congressional Effort Aims to Foster Development of New Drugs and Diagnostics
Key members of Congress are focusing their attention on policy proposals to speed patient access to new therapies. U.S. Reps. Fred Upton (R-MI) and Diana DeGette (D-CO) recently announced their 21st Century Cures Initiative aimed at accelerating the discovery, development, and delivery of promising new treatments to patients. IDSA is working with the lawmakers to bring the infectious disease perspective to the table, emphasizing strategies for spurring the development of new antibiotics and rapid diagnostic tools.|
IDSA responded to the Initiative’s first white paper with details on the economic and regulatory obstacles to research and development (R&D) of new antibiotics and rapid infectious disease diagnostics. The Society supports several policy proposals including:
IDSA also promoted policies recommended in its 2013 “Better Tests, Better Care” paper, including establishing a biorepository to help foster diagnostic development, and funding outcomes research to demonstrate the impact of diagnostics on patient care and encourage the appropriate use of antibiotics.
- The Antibiotic Development to Advance Patient Treatment (ADAPT) Act, which would create a new approval pathway at the Food and Drug Administration in which companies could use smaller clinical trials to study new antibacterial or antifungal drugs that treat serious or life-threatening infections for which there is an unmet medical need. Companies would receive approval for the limited population in most need of these therapies,
The Developing Innovative Strategies for Antimicrobial Resistance Microorganisms (DISARM) Act, which addresses prevention, surveillance, and R&D,
Tax credits for antibiotics and rapid diagnostics proposals,
Public and private partnerships, and
- Increased funding for research through the National Institute for Allergy and Infectious Diseases (NIAID), Biomedical Advanced Research and Development Authority (BARDA) and other federal agencies.
The second white paper sought input on recommendations made in the 2012 President’s Council of Advisors on Science and Technology (PCAST) Report on drug development. IDSA responded, again using this opportunity to highlight its antimicrobial drug incentives proposals.
Lastly, the third white paper sought input from a patient perspective regarding what treatments are most urgently needed and how the federal government can help spur their development. Because there are no large, highly organized patient organizations representing individuals with multidrug-resistant organisms, IDSA responded on behalf of the many patients its members treat. This response highlighted patient stories and again made the compelling case for urgently needed new antimicrobial drugs.
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