Generating Antibiotic Incentives Now Act of 2010
Latest action · Sep 29, 2010 Referred to the House Committee on Energy and Commerce.
Progress
Where this bill reached, and when. A stage with no date was not reached; one that failed a vote and later carried shows the date it carried.
- IntroducedSep 29, 2010
- Passed HouseNot reached
- Passed SenateNot reached
- To the PresidentNot reached
- Became lawNot reached
Summary
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.
Cosponsors 4
Members who signed on, in the order they did. All signed on Sep 29, 2010.
| Seat | Cosponsor | Signed on | |
|---|---|---|---|
| D-CO | Diana DeGette | Original | Sep 29, 2010 |
| R-KY | Ed Whitfield | Original | Sep 29, 2010 |
| D-TX | Gene Green | Original | Sep 29, 2010 |
| R-MI | Mike Rogers | Original | Sep 29, 2010 |
Actions 2
Everything that happened, newest first.
- Sep 29, 2010Introduced in House
- Sep 29, 2010Referred to the House Committee on Energy and Commerce.
Subjects
Assigned by the Library of Congress. Policy area: Health.
- Administrative law and regulatory procedures
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Food and Drug Administration (FDA)
- Health
- Infectious and parasitic diseases
- Intellectual property
- Medical research
- Medical tests and diagnostic methods
- Prescription drugs
Text 1
Each version as it was printed, newest first.
- Sep 29, 2010Introduced in House
Everything here is as published by Congress: the summary is the Congressional Research Service's, the action wording is the clerks', and the subjects are the Library of Congress's. How far it got is read from the actions themselves, taking the most recent one of each kind, so a bill that failed a vote and later passed is shown as having passed. Records come from this bill on Congress.gov and govinfo.gov.