3.0.0 3921 2023-01-11T13:21:21Z 2023-01-11T13:21:21Z Senate S S 2010-09-29 111 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2010-09-29T22:55:04Z 2010-09-29 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2010-09-29 Introduced in Senate IntroReferral 10000 9 Library of Congress S000033 Sen. Sanders, Bernard [I-VT] Bernard Sanders I VT N Health Animal protection and human-animal relationships Drug safety, medical device, and laboratory regulation Government information and archives Human rights Licensing and registrations Medical ethics Medical research Health 00 2010-09-29 Introduced in Senate 2011-02-11T22:39:28Z Ethical Pathway Act of 2010 - Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs (FDA), to establish a mechanism by which an applicant for an abbreviated new drug application submitted under the Federal Food, Drug, and Cosmetic Act, for license of a biosimilar biological product submitted under the Public Health Service Act, or for a license to sell in the United States a drug that has been approved for marketing in a foreign country may request a cost-sharing arrangement under which the applicant and the holders of relevant applications or licenses shall make every effort to ensure that any regulatory test data and results of clinical investigations involving humans and vertebrate animals conducted regarding such applications or licenses is shared, including the regulatory test data necessary to obtain marketing approval from the Secretary.

Permits such applicant to request such arrangement if, but for the arrangement: (1) the applicant would be required to conduct clinical investigations involving human subjects that violate Article 20 of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects in order to obtain the Secretary's approval or licensure; or (2) the duplication of the clinical investigations required for such application would violate other applicable ethical standards concerning the testing of products on humans or other vertebrate animals.

Sets forth provisions regarding: (1) the responsibility of an applicant that intends to perform clinical investigations involving humans or vertebrate animals to verify that those investigations have not been performed or initiated by another person, (2) agreement between an applicant and the holders of the relevant applications or licenses on a fee that is reasonable and fair that permits the applicant to rely upon information from such regulatory test data, and (3) procedures to determine such fee or required payment when such parties fail to reach such an agreement.

Requires the fee for reliance on such regulatory test data to be determined after considering: (1) the actual out-of-pocket costs of the applicable clinical investigations; (2) the risks of the investigations; (3) any federal grants, tax credits, or other subsidies; (4) the expected share of the global market for the product involved; and (5) the amount of time the holders of the relevant applications or licenses have benefited from exclusive rights and the cumulative revenue earned on the products that relied upon the data at issue. Directs the Secretary to adopt procedures and rules under which sufficient information about costs and fees will be made public.

]]> Ethical Pathway Act of 2010 Display Title Ethical Pathway Act of 2010 Official Title as Introduced A bill to ensure that rules for the approval of pharmaceutical and biological products do not require violations of medical ethics in the testing of products in humans and vertebrate animals. Introduced in Senate IS Short Titles as Introduced Ethical Pathway Act of 2010 Introduced in Senate 2010-09-29T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-111s3921is/xml/BILLS-111s3921is.xml 2010-09-29 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. 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.