3.0.0 1636 2023-01-11T13:43:53Z 2023-01-11T13:43:53Z Senate S 2019-05-23 116 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Discharged from 2020-12-15T00:10:16Z Referred to 2019-05-23T16:27:10Z Protecting Access to Safe and Effective Medicines Act of 2019 116 4955 HR 2019-11-01 Referred to the Subcommittee on Health. Related bill CRS Lower Costs, More Cures Act of 2019 116 19 HR 2019-12-19 Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law. Related bill CRS Lower Health Care Costs Act 116 1895 S 2019-07-08 Placed on Senate Legislative Calendar under General Orders. Calendar No. 133. Related bill CRS 2020-12-15 15:41:26 Held at the desk. Floor H15000 2 House floor actions 2020-12-15 15:03:07 Received in the House. Floor H14000 2 House floor actions 2020-12-15 Senate Message on Senate action sent to the House. Floor 2020-12-14 Senate Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7470) Floor 2020-12-14 Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.(text of amendment in the nature of a substitute: CR S7470) Floor 17000 9 Library of Congress 2020-12-14 Senate Measure laid before Senate by unanimous consent. (consideration: CR S7470) Floor 2020-12-14 sshr00 Health, Education, Labor, and Pensions Committee Senate Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. Discharge 2020-12-14 Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent. Committee 14500 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2019-05-23 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2019-05-23 Introduced in Senate IntroReferral 10000 9 Library of Congress R000307 Sen. Roberts, Pat [R-KS] PAT ROBERTS R KS N S001203 Sen. Smith, Tina [D-MN] Tina Smith D MN 2019-05-23 True C001075 Sen. Cassidy, Bill [R-LA] Bill Cassidy R LA 2019-05-23 True Health Administrative law and regulatory procedures Chemistry Department of Health and Human Services Drug safety, medical device, and laboratory regulation Health 00 2019-05-23 Introduced in Senate 2021-05-25T14:09:13Z Ensuring Innovation Act

This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining active ingredient more narrowly as active moiety in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases.

Generally, the FDA defines active moiety as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an active ingredient as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting active ingredient as active moiety in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity.

The bill replaces references to active ingredient with active moiety in various statutes authorizing FDA activities.

]]> 55 2020-12-14 Passed Senate 2021-09-12T17:02:07Z This bill provides statutory authority for the existing Food and Drug Administration (FDA) practice of defining active ingredient more narrowly as active moiety in certain situations, such as when determining whether a new drug is entitled to a market exclusivity period or providing priority review of drugs for treating rare pediatric diseases.

Generally, the FDA defines active moiety as the core molecule or ion in a drug responsible for the relevant physiological or pharmacological action. By contrast, the FDA defines an active ingredient as a component in a drug that is intended to furnish pharmacological activity or other direct effect. The FDA's existing practice of interpreting active ingredient as active moiety in certain situations, as statutorily authorized by this bill, tends to exclude some drugs from market exclusivity.

The bill replaces references to active ingredient with active moiety in various statutes authorizing FDA activities.

]]> Ensuring Innovation Act Display Title Ensuring Innovation Act Short Title(s) as Introduced Ensuring Innovation Act Introduced in Senate IS Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the scope of new chemical exclusivity. Introduced in Senate IS 2707 116 SAMDT In the nature of a substitute. 2022-02-08T23:03:55Z 2020-12-14 Amendment SA 2707 agreed to in Senate by Unanimous Consent. SA 2707 https://www.congress.gov/amendment/116th-congress/senate-amendment/2707 A000360 Sen. Alexander, Lamar [R-TN] Lamar Alexander R TN 2020-12-14T05:00:00Z 2020-12-14T05:00:00Z Senate 116 S Senate S 1636 Ensuring Innovation Act 2023-01-11T13:43:53Z 6 2020-12-14 0 Senate Amendment SA 2707 agreed to in Senate by Unanimous Consent. Floor 2020-12-14 0 Senate Amendment SA 2707 proposed by Senator McConnell for Senator Alexander. (consideration: CR S7470; text: CR S7470) In the nature of a substitute. Floor 2020-12-14 Senate amendment submitted Floor 91000 9 Library of Congress 2020-12-14 Senate amendment proposed (on the floor): Amendment SA 2707 proposed by Senator McConnell for Senator Alexander. Floor 93000 9 Library of Congress 2020-12-14 Senate amendment agreed to: Amendment SA 2707 agreed to in Senate by Unanimous Consent. Floor 94000 9 Library of Congress Engrossed in Senate 2020-12-14T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s1636es/xml/BILLS-116s1636es.xml Introduced in Senate 2019-05-23T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s1636is/xml/BILLS-116s1636is.xml 2020-12-15 Held at the desk. 15:41:26 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.