H.R. 2182/S. 1734, the Generating Antibiotic Incentives Now Act of 2011, would provide incentives for the development of qualified infectious disease products. The legislation has provisions for:
- extending the exclusivity period for new qualified infectious disease products;
- priority review to the application for approval or licensure for qualified infectious disease products;
- fast tracking a drug which the Secretary determines is a qualified infectious disease product;
- a study on incentives for qualified infectious disease biological products; and,
- reviewing and revising guidelines of the Food and Drug Administration for the conduct of clinical trials with respect to antibiotics.
Key Points in Support:
- The AVMA strongly endorses the One Health principle that demonstrates the importance that medical professionals have in preserving the health and well-being of all species. We believe that H.R. 2182/S. 1734 supports this principle, as human health and animal health are both benefited by development of infectious disease products.
- The creation of new antibiotic treatments may facilitate access to medication for animals. At the same time, the introduction of new antibiotic treatments for human medicine could alleviate some of the pressures on veterinary use of antimicrobial therapies.
H.R.2182 was introduced on June 15, 2011, by Rep. Phil Gingrey (R-GA-11th). It was referred to the House Committee on Energy and Commerce. S. 1734 was introduced on 10/19/11, by Sen. Richard Blumenthal (CT) and referred to the Senate Committee on Health, Education, Labor and Pensions.