Editor’s Note: The Infectious Diseases Society of America Comments on the 21st Century Cures bill, a bill desigend “to help modernize and personalize health care, encourage greater innovation, support research” including important issues surrounding antimicrobial resistance and antibiotic development.
Ms. Amanda Jezek has been Director of Government Relations at Infectious Diseases Society of America (ISDA) since July 2011. Ms. Jezek is “is responsible for policy development and advocacy on IDSA priority issues including antimicrobial resistance, antimicrobial and diagnositcs development, preparedness and federal funding’.
MedicalResearch: What are the main objectives of the 21st Century Cures bill?
Ms. Jezek: This question goes far beyond IDSA’s work on the bill, so I would not be comfortable being quoted on this. The Energy and Commerce Committee’s website has more information. Very generally, the bill seeks to advance the research and development of new cures for patients with a wide variety of diseases and conditions.
MedicalResearch: What health care needs and problems does it address?
Ms. Jezek: I can only answer from IDSA’s perspective, keeping in mind that many sections of this bill go well beyond the field of ID. IDSA is very pleased that the bill prioritizes the research and development of some of the most urgently needed new antibiotics to treat serious or life threatening infections with few or no current treatment options. IDSA is also very pleased that the bill takes important steps to increase funding for NIH, which is urgently needed to ensure adequate investment in biomedical research and support for young people entering or thinking of pursuing research careers.
MedicalResearch: Does the proposed legislation address hospital-based infections, antibiotic resistance, pandemic detection and management, vaccine issues such as mandatory vaccination of school age children, or antibiotics in food sources?
Ms. Jezek: The bill’s focus is really biomedical research and development and as these issues fall more into the public health sphere, they are not the specific focus of the bill. However, the provisions aimed at antibiotic R&D also include language aimed at making sure the antibiotics are used appropriately and that their use is monitored, both of which are critical for addressing antibiotic resistance.
MedicalResearch: Does the legislation enable simplified access to clinical medical research trials or expedited review of new pharmaceuticals and medications?
Ms. Jezek: I’m only answering from IDSA’s perspective, understanding that we are not involved in every provision in the bill and other provisions may address these issues. One of the antibiotics provisions, which IDSA has been championing, would allow antibiotics to treat serious or life threatening infections with few or no current treatment options to be studied in smaller, more rapid clinical trials and approved only for the limited population of patients who need them. This approach is needed because some of the most deadly, difficult to treat infections currently occur in small numbers of critically ill patients who are difficult to enroll in clinical trials, making it very difficult and sometimes impossible to populate traditional, large clinical trials.
MedicalResearch: How will patients benefit from bill?
Ms. Jezek: The bill will help enable the development of new safe and effective antibiotics to treat infections that could otherwise be lethal. Such antibiotics could literally mean the difference between life or death for patients with these infections.
MedicalResearch: What should health care providers be aware of if the legislation passes?
Ms. Jezek: I think all of the components that IDSA is pursuing—specifically regarding antibiotic development and NIH funding—would be of great interest to providers given their potential impact on new treatment options for patients.
MedicalResearch: Is funding for implementation of the bill included in the legislation?
Ms. Jezek: As I understand it, the Committee is still working on some of this, so I can only provide a partial answer. For the NIH funding-the bill would authorize new money for NIH for the next 3 years, but the Appropriations Committee in Congress would still need to actually appropriate that money. However, the NIH Innovation Fund in the bill would provide mandatory funding for NIH for the next 5 years, and this would not have to be approved by the Appropriations Committee. Some parts of the bill (such as the limited population antibiotic development provision discussed above) are not expected to require additional funding, as it is merely addressing a regulatory barrier. Lastly, some funding items are still being worked out.
(See a two-page Fact Sheet of H.R. 6 HERE. )
Ms. Amanda Jezek, Director of Government Relations, & Infectious Diseases Society Of America (2015). The Infectious Diseases Society of America Comments on the 21st Century Cures Bill Including Antibiotic Development