H.R.6331 - Generating Antibiotic Incentives Now Act of 2010111th Congress (2009-2010)
Summary: H.R.6331 — 111th Congress (2009-2010)
Introduced in House (09/29/2010)
Generating Antibiotic Incentives Now Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act to: (1) extend for five years the exclusivity period for the first licensure of a qualified infectious disease product; (2) grant priority review to an application for approval or licensure of a qualified infectious disease product (i.e., review and action on such application not later than six months after receipt); and (3) deem a qualified infectious disease product as a fast track product, for review and approval purposes. Defines "qualified infectious disease product" as an antibiotic drug, or a diagnostic test including a point-of-care diagnostic test, for treating, detecting, preventing, or identifying a qualifying pathogen.
Requires the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to review the guidelines of the Food and Drug Administration (FDA) for the conduct of clinical trials for antibiotic drugs and revise such guidelines to reflect developments in medical information and technology. Allows the sponsor of a drug intended to be used to treat, detect, prevent, or identify a qualifying pathogen, as defined by this Act, to request that the Secretary provide written recommendations for nonclinical and clinical investigations before such drug may be approved for use or licensed.