3.0.0 4816 2023-01-11T13:16:25Z 2023-01-11T13:16:25Z House H HR 2010-03-10 111 hsif00 Energy and Commerce Committee House Standing Referred to 2010-03-10T15:03:47Z 2010-03-10 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2010-03-10 Introduced in House IntroReferral Intro-H 9 Library of Congress 2010-03-10 Introduced in House IntroReferral 1000 9 Library of Congress H000627 Rep. Hinchey, Maurice D. [D-NY-22] MAURICE HINCHEY D NY D. 22 N Health Administrative law and regulatory procedures Advisory bodies Civil actions and liability Consumer affairs Department of Health and Human Services Drug safety, medical device, and laboratory regulation Executive agency funding and structure Food and Drug Administration (FDA) Government information and archives Marketing and advertising Medical ethics Prescription drugs User charges and fees Health 00 2010-03-10 Introduced in House 2010-05-21T20:46:26Z Food and Drug Administration Improvement Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, animal drugs, or generic animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services (HHS) 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, Device, and Biologic 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, the Center for Biologics Evaluation and Research, or the Center for Devices and Radiological Health Organization.

Requires a statement regarding the reporting of negative side effects of prescription drugs in televised direct-to-consumer drug advertisements (currently required in published advertisements).

Requires the Commissioner of Food and Drugs to: (1) complete a review of the FDA's regulations and guidance pertaining to the labeling of drugs and biological products; and (2) post on the FDA's website all clinical trial adverse events included in the registry and results data bank of the National Institutes of Health (NIH).

Requires payment of a fee to the Secretary for the advertisement of drugs and devices.

Requires doctors to inform patients and obtain consent to prescribe an approved drug for a purpose that has not been approved by the FDA.

]]> Food and Drug Administration Improvement Act of 2010 Display Title Food and Drug Administration Improvement Act of 2010 Official Title as Introduced 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. Introduced in House IH Short Titles as Introduced Food and Drug Administration Improvement Act of 2010 Introduced in House 2010-03-10T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111hr4816ih/xml/BILLS-111hr4816ih.xml 2010-03-10 Referred to the House Committee on Energy and Commerce. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.