S. 3921: Ethical Pathway Act of 2010
Before you vote › Federal bills
S. 3921: Ethical Pathway Act of 2010
111th Congress · introduced 2010-09-29 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
federal
Follow this bill, step by step
- Where it came from: introduced 2010-09-29 · official record
- Who proposed it: Sen. Sanders, Bernard [I-VT] · what a sponsor is
- What happened next: no floor votes in our records yet. Why?
- Where it stands now: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Not final yet: this can still change. We check for updates every day.
- If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.
Official title
Ethical Pathway Act of 2010
Plain summary
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.
Congressional Research Service summary (Introduced in Senate), quoted unchanged (nonpartisan). Read the source.
What a vote does
A “Yea” vote
If it passes both chambers and is signed, it becomes law.
A “Nay” vote
If it is not passed, current law stays as it is.
PSI Sci description of the legislative step (not an opinion).
What does this mean? (plain words)
Official text
Ethical Pathway Act of 2010
Source: Congressional Research Service summary (Introduced in Senate)
AI explanation – may be wrong, check the official text
No AI explanation yet. It takes up to a minute to write and is then saved for everyone.
Limited to a few requests an hour per person.
The strongest published arguments
Arguments for (supporters)
Needs sources: no published arguments on this side yet. We only show items backed by a published source. Suggest one.
Arguments against (opponents)
Needs sources: no published arguments on this side yet. We only show items backed by a published source. Suggest one.
Alternatives
Needs sources: no published alternatives yet (for example a different bill, a law instead of an amendment, or keeping current law). We only show items backed by a published source. Suggest one.
How did my representative vote? · This bill's floor votes
Officials and money
Sponsor: Sen. Sanders, Bernard [I-VT] · 0 cosponsors
Cost estimate: No cost estimate published yet.
Sponsor's campaign money: Sen. Sanders, Bernard [I-VT] reported raising $26.5 million (2025–2026). Details. Shown for context only; it does not mean any donor supported this bill.
No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.
Words on this page, explained (1)
- Rulemaking
- The process agencies use to write regulations that carry out laws passed by Congress or a legislature. Usually an agency publishes a proposed rule, takes public comments, then publishes a final rule.
Plain meanings written from linked sources. All words.
Sources
- Congressional Research Service summary (Introduced in Senate)
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-111s3921.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/111/s>
Record fed-us-cong111-s3921 · catalog fed-us-congress-bills-cong111 · updated 2026-11-15 by psicol fed-bills-cong111