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May 2015
POLICY AND ADVOCACY
Antibiotics Incentives and NIH Funding Boost in 21st Century Cures Draft Bill

An important congressional committee has released a second bipartisan draft of its comprehensive 21st Century Cures bill, which is aimed at accelerating the discovery, development, and delivery of promising new treatments to patients. Much of the bill is still being negotiated, but it contains several key IDSA priorities, including: the limited population antibacterial drug (LPAD) approval pathway, funding increases for the National Institutes of Health (NIH), and quicker Food and Drug Administration (FDA) review of diagnostic tests and other medical devices that do not have sufficient alternatives.

At a recent House committee hearing to discuss the draft bill, several members of Congress expressed the importance of addressing antibiotic resistance and spurring the development of urgently needed new antibiotics. LPAD champions, Reps. John Shimkus (R-IL) and Gene Green (D-TX), discussed the need for the LPAD proposal to allow antibiotics and antifungals that treat serious or life-threatening infections with an unmet medical need to be studied in smaller, more rapid clinical trials, given that the targeted infections currently occur in a relatively small number of patients. The draft Cures bill also contains safeguards to help guide appropriate use of the drugs, as well as provisions to speed the updating of antimicrobial susceptibility breakpoints and to increase reimbursement for new antibiotics and antifungals that treat serious or life-threatening infections with an unmet medical need.

Help IDSA Support LPAD

Please take two minutes to email your representatives through this simple link to encourage them to support LPAD. Constituent support is critical to make sure LPAD continues to advance. 

The new draft Cures legislation includes new provisions aimed at strengthening NIH funding. Specifically, the bill would authorize $31.8 billion for NIH for 2016, $33.3 billion for 2017, and $34.8 billion for 2018 (although these amounts would still be subject to annual the annual appropriations process). The bill would also establish an NIH Innovation Fund to provide an additional $2 billion per year for specific initiatives including supporting emerging young scientists, precision medicine, and other priorities yet to be specified. The draft also includes new language indicating that Congress is supportive of federal scientists participating in scientific conferences and meetings.

Help IDSA Support NIH Funding

To effectively advocate for increased NIH funding, IDSA needs more stories from members about how funding cuts in recent years have impacted your work. If you are willing to share your story, please contact Jonathan Nurse, IDSA’s Director of Government Relations, at jnurse@idsociety.org or (703) 299-0202.

The draft bill contains some provisions of concern to IDSA.  With regard to vaccines, the bill contains a provision that we believe seeks to micromanage the Advisory Committee for Immunization Practices (ACIP) process and requires Centers for Disease Control and Prevention (CDC) to meet with any vaccine manufacturer within 90 days of a request without providing CDC any additional resources to support such activities.  The draft bill retains provisions that raised concern among many in the scientific community about congressional micromanagement of NIH, including requiring detailed strategic plans from NIH institutes. All of these provisions remain under negotiation, and IDSA will continue to work with other medical and scientific societies, public health groups, patient groups and other key stakeholders to advocate for our priorities.


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