FDA Safety and Innovation Act a Critical Weapon Against Antimicrobial Resistance: IDSA Commends Congressional Action to Incentivize Antibiotic Development

Demonstrating Support, American Medical Association House of Delegates Passes Resolutions Related to Antibiotic Resistance

Statement from IDSA President Thomas G. Slama, MD, FIDSA:

Congress took important action today against the public health threat of antibiotic resistance by passing the Food and Drug Administration Safety and Innovation Act (S 3187)* with provisions to address the lack of new antibiotics in development. The Act provides incentives to spur renewed interest in antibiotic research and development (R&D), to bring new antibiotics to the American people and provide ammunition against increasing drug resistance nationwide. It also calls for a review of antimicrobial stewardship programs as a critical tool for protecting the antibiotics we currently have against resistance, which can render them ineffective.

We are incredibly grateful to the bipartisan members of the House and Senate, including Reps. Phil Gingrey and Gene Green, and Sens. Richard Blumenthal and Bob Corker, for leading the charge in taking this important step in addressing this public health crisis.

While this was a critical first step, more work will be needed to ensure new antibiotics come to market, as outlined in IDSA’s 10 x ‘20 Initiative. We will continue to work with the other endorsers of the initiative to advocate for: 

• Tax credits for R&D (which will bring antibiotics into parity with Orphan Drugs)
• Public-private collaborations (PPCs) 
• The Limited Population Antibacterial Drug (LPAD) mechanism to streamline FDA approval (see http://www.idsociety.org/2012_LPAD_Proposal_Backing/) 
• New, improved diagnostics to ensure antibiotics are used appropriately post-approval

In addition to Congress, the American Medical Association’s (AMA) House of Delegates (HOD) also voiced its support of the development of critically needed new antibiotics as well as the protection of antibiotics once approved. The AMA HOD’s actions demonstrate organized medicine’s recognition of the vital importance of antibiotics, their uniqueness among medicines (i.e., they promote antibiotic resistance, which makes them less effective over time), and the need to create specialized mechanisms to both stimulate antibiotics’ development as well as protect their effectiveness for as long as possible.

We commend the AMA HOD for recognizing that “the LPAD mechanism is an extremely promising potential tool for bringing high priority antibiotics to market” and acknowledging the importance of antimicrobial stewardship along with infection control programs “as critical components of assuring safe patient care.” To see the full resolutions, go to:

• Report No. 20-A-12: Requiring Antimicrobial Stewardship and Infection Prevention Programs as Conditions of Participation Under Medicare (proposed by IDSA)
• Resolution No. 213: Establishment of Limited Population Antibacterial Drug (LPAD) Approval Pathway (sponsored by IDSA along with the American Association of Hip and Knee Surgeons, American College of Medical Quality, American College of Rheumatology and American Thoracic Society)

For more information about IDSA’s 10 x ’20 Initiative and other efforts to address antimicrobial resistance, visit www.AntibioticsNow.org.

* The Food and Drug Administration Safety and Innovation Act is a reconciled version of the Prescription Drug User Fee Act (PDUFA). 

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