IDSA Commends Bipartisan Agreement on FDA Safety and Innovation Act

Thomas G. Slama, MD, FIDSA, president of the Infectious Diseases Society of America (IDSA), issued the following statement today:

"In a critical move in the fight against antibiotic resistance, House and Senate members announced a bipartisan agreement on the Food and Drug Administration Safety and Innovation Act (S 3187) late yesterday, including language to address the dry antibiotic research and development (R&D) pipeline and bring new antibiotics to the American people.

"IDSA has advocated for antibiotic incentives for many years, and the Society is very grateful to the bipartisan members of the House and Senate, and in particular to Reps. Phil Gingrey and Gene Green, and Sens. Richard Blumenthal and Bob Corker, for leading the charge, as well as the leaders of both House and Senate health committees. We hope these incentives begin to garner renewed interest in this critical area of medicine.

"In order to bring antibiotics to patients who desperately need them in the United States and abroad, as outlined in our 10 x 20 initiative, other types of incentives will be necessary. These should include tax credits for R&D (which will bring antibiotics into parity with Orphan Drugs), public-private collaborations (PPCs), and the Limited Population Antibacterial Drug (LPAD) mechanism to streamline FDA approval (see http://www.idsociety.org/2012_LPAD_Proposal_Backing/), which IDSA proposed this spring. New, improved diagnostics also are critically important for antibiotic development as well as for ensuring that antibiotics are used appropriately post-approval. IDSA will continue to work with the other endorsers of the 10 x 20 initiative to lead the charge for additional action.

"The Safety and Innovation Act legislation took another important step in the right direction by directing the Department of Health and Human Services to report to Congress on the need for additional incentives, particularly PPCs, thanks to language championed by IDSA and Rep. Henry Waxman.  Also at the insistence of IDSA and Rep. Waxman, the Act calls for a review of antimicrobial stewardship programs, which are critical to protect antibiotics against the rapid development of resistance.

"The bipartisan agreement was announced by House Energy and Commerce Committee Chairman Fred Upton (R-MI), Ranking Member Henry A. Waxman (D-CA), Senate HELP Committee Chairman Tom Harkin (D-IA), and Ranking Member Mike Enzi (R-WY). The House and Senate are expected to take action on the Act this week. "

For more information about IDSAs 10 x 20 Initiative and other efforts to address the public health crisis of antibiotic resistance, visit www.AntibioticsNow.org.

 

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