IDSA continues to make progress advocating for new drugs and diagnostics to address drug-resistant infections, with promising signals coming from Congress, the Food and Drug Administration (FDA), and the White House. Meanwhile, two new drugs could soon get FDA approval—potentially counting toward IDSA’s 10x'20 goal.|
At the White House, the President’s Council of Advisors on Science and Technology (PCAST) is expected to issue a report on antimicrobial resistance and recommendations to President Obama in May. Topics under consideration include: federal coordination of stakeholders, antibiotic stewardship in human healthcare and agricultural settings, economic incentives for antibiotic development, collection of data on antibiotic use (including dosage and duration of therapy), better clinical trial designs, limited population antibiotic development, and the need for new rapid diagnostics. IDSA’s Vice President for Public Policy & Government Relations, Amanda Jezek, delivered brief oral remarks at an April 4 meeting of PCAST, and the Society also submitted comments.
In Congress, U.S. Reps. Phil Gingrey (R-GA) and Gene Green (D-TX) have lined up several new cosponsors for the Antibiotic Development to Advance Treatment (ADAPT) Act (PDF), which IDSA supports. The bipartisan group includes Reps. Bill Cassidy (R-LA), John Barrow (D-GA), John Dingell (D-MI), Renee Ellmers (R-NC), Leonard Lance (R-NJ), Bob Latta (R-OH), Jim Matheson (D-UT), Doris Matsui (D-CA), Pete Olson (R-TX), Mike Pompeo (R-KS), Paul Tonko (D-NY), and John Yarmuth (D-KY). IDSA continues to work closely with Gingrey and Green to strengthen the bill’s provision regarding antibacterial drug labeling and to push for a committee hearing on the bill. IDSA members can use the web action alert to ask their House members to support the ADAPT Act.
At FDA, IDSA presented testimony and provided comments to the Anti-Infective Advisory Committee (AIDAC), which was reviewing tedizolid and dalbavancin. Although IDSA does not take a position on specific drugs or companies, the Society was able to weigh in on the need for new antibiotics. The Committee voted to recommend approval tedizolid (14-0) and dalbavancin (12-0, 2 abstentions) for acute bacterial skin and skin structure infections.
IDSA also submitted comments to the FDA on the agency’s recent guidance for industry on community-acquired-bacterial pneumonia clinical trials. The Society applauded the agency’s efforts to make clinical trials more feasible and offered recommendations to improve the guidance.
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