Food and Drug Administration Improvement Act of 2007

To amend the Federal Food, Drug, and Cosmetic Act to provide for the deposit in the general fund of the Treasury of fees that are collected from manufacturers of drugs and devices under chapter VII of such Act, to terminate the authority of the Food and Drug Administration to negotiate with the manufacturers on particular uses of the fees, to establish a Center for Postmarket Drug Safety and Effectiveness, to establish additional authorities to ensure the safe and effective use of drugs, and for other purposes.

5/10/2007--Introduced.
Food and Drug Administration Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, and animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services to review such applications. Prohibits the Secretary from entering into agreements with persons from whom such fees are collected and terminates any existing agreements. Requires the Secretary to:
(1) establish the Center for Postmarket Drug Safety and Effectiveness within the Food and Drug Administration (FDA) to regulate approved drugs; and
(2) transfer to the Center all responsibilities for such regulation from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Allows the Secretary to require manufacturers of approved drugs to conduct studies of an identified significant safety issue with the drug. Deems a drug to be misbranded if it does not meet the Secretary's requirements, including requirements for labeling and conducting postmarket studies. Requires the Secretary to follow the interpretation that the FDA used in 1999 that the FFDCA and Public Health Service Act establish minimal standards but do not preclude additional state requirements. Requires the Secretary to cease intervening in product liability civil actions to argue another interpretation. Sets forth procedures for advisory committee meetings to ensure that the committee is fairly balanced. Prohibits any exemptions from being granted to advisory committee members from rules prohibiting members from having a personal financial interest in the outcome. Requires doctors to inform patients and obtain consent to prescribe an approved drug for a purpose that has not been approved by the FDA.


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Sponsor

• Rep. Maurice Hinchey [D, NY-22]
• and 2 Co-Sponsors
  • Rep. Raul Grijalva [D, AZ-7]
  • Rep. Bart Stupak [D, MI-1]
  close

Committees

• House Energy and Commerce
• 1 more
  • House Energy and Commerce
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Amendments

This bill has no amendments.

Amendments to H.R.2273

Number	Status	Purpose

Bill Status

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Introduced		Voted on by House		Voted on by Senate		Considered By President		Bill Becomes Law
May 10, 2007

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All Bill Actions

• May 10, 2007: Referred to the Subcommittee on Health.
• May 10, 2007: Referred to the House Committee on Energy and Commerce.
• Introduced on May 10, 2007.

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Related Issue Areas:

• Medical supplies
• Medicine
• Administrative fees
• Animals
• 47 more
• Budgets
• Business
• Clinical trials
• Communication in medicine
• Communications
• Conflict of interests
• Consumer education
• Consumer protection
• Consumers
• Data banks
• Department of Health and Human Services
• Drug advertising
• Drug approvals
• Drug industry
• Drugs
• Executive departments
• Executive reorganization
• Federal advisory bodies
• Federal-state relations
• Fines (Penalties)
• Food and Drug Administration (FDA)
• Government and business
• Government ethics
• Government information
• Government publicity
• Health education
• Health information systems
• Health policy
• Informed consent (Medical law)
• Labeling
• Law
• Medical care
• Medical ethics
• Medical instruments and apparatus
• Medical research
• Parties to actions
• Physicians
• Politics and government
• Product safety
• Products liability
• Science policy
• State and local government
• State courts
• State laws
• Technology
• Veterinary medicine
• Warning labels

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Blog Coverage

August 06, 2007 Updates

HR 2273: The bill on Biofuels Research and Development Enhancement was reported (amended) by the Committee on Science and Technology and placed on the Union Calednar, No. 189. HR 3093: Blog Article Status Report ...

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June 16, 2007 Blog Comment: re: The FDA Has Blood on its Hands

On May 10, 2007 Congressman Maurice Hinchey (NY) introduced the Food and Drug Administration Improvement Act (FDAIA) HR-2273, a broad reform bill that would end the inappropriately close relationship between the drug industry and the ...

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May 09, 2007 Bill Action: Introduced: HR 2273: To amend the Federal Food, Drug ...

Maurice Hinchey [D-NY] introduced HR 2273: To amend the Federal Food, Drug, and Cosmetic Act to provide for the deposit in the general fund of the Treasury of fees that are collected from manufacturers of drugs and devices under chapter ...

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