3.0.0 2740 2022-11-01T04:47:39Z 2022-11-01T04:47:39Z Senate S 2019-10-30 116 hsif00 Energy and Commerce Committee House Standing hsif14 Health Subcommittee Referred to 2019-12-14T17:56:54Z Referred to 2019-12-12T00:12:25Z sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2019-11-05T22:39:14Z Markup by 2019-10-31T14:00:34Z Referred to 2019-10-30T17:58:53Z Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 116 269 HR 2019-01-10 Read the second time. Placed on Senate Legislative Calendar under General Orders. Calendar No. 10. Related bill CRS To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. 116 3443 HR 2019-07-24 Sponsor introductory remarks on measure. (CR E971) 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 CARES Act 116 748 HR 2020-07-23 Committee on Small Business and Entrepreneurship. Hearings held. Related bill CRS 2019-12-14 hsif14 Health Subcommittee 1 House committee actions Referred to the Subcommittee on Health. Committee 2019-12-11 Referred to the House Committee on Energy and Commerce. IntroReferral H11100 2 House floor actions hsif00 Energy and Commerce Committee 2019-12-11 12:31:01 Received in the House. Floor H14000 2 House floor actions 2019-12-11 Senate Message on Senate action sent to the House. Floor 2019-12-10 Senate Passed Senate without amendment by Yea-Nay Vote. 91 - 2. Record Vote Number: 389. (consideration: CR S6921-6930; text: CR S6921-6930) Floor 389 https://www.senate.gov/legislative/LIS/roll_call_votes/vote1161/vote_116_1_00389.xml Senate 116 2019-12-10T20:41:48Z 1 2019-12-10 Passed/agreed to in Senate: Passed Senate without amendment by Yea-Nay Vote. 91 - 2. Record Vote Number: 389.(consideration: CR S6921-6930; text: CR S6921-6930) Floor 17000 9 Library of Congress 389 https://www.senate.gov/legislative/LIS/roll_call_votes/vote1161/vote_116_1_00389.xml Senate 116 2019-12-10T20:41:48Z 1 2019-11-05 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 290. Calendars 2019-11-05 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report. Committee 2019-11-05 Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2019-10-31 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably. Committee 2019-10-30 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2019-10-30 Introduced in Senate IntroReferral 10000 9 Library of Congress I000055 Sen. Isakson, Johnny [R-GA] Johnny Isakson R GA N C001070 Sen. Casey, Robert P., Jr. [D-PA] Bob Casey D PA 2019-10-30 True B001310 Sen. Braun, Mike [R-IN] Mike Braun R IN 2019-10-31 False A000360 Sen. Alexander, Lamar [R-TN] Lamar Alexander R TN 2019-11-07 False M001111 Sen. Murray, Patty [D-WA] Patty Murray D WA 2019-11-07 False S001191 Sen. Sinema, Kyrsten [D-AZ] Kyrsten Sinema D AZ 2019-12-10 False Health Administrative law and regulatory procedures Administrative remedies Child health Congressional oversight Cosmetics and personal care Department of Health and Human Services Drug safety, medical device, and laboratory regulation Government information and archives Government studies and investigations Inflation and prices Judicial review and appeals Marketing and advertising User charges and fees Health 00 2019-10-30 Introduced in Senate 2021-09-13T16:42:19Z Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs.

The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug.

The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval.

The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients.

The FDA must establish a user fee program for OTC drugs.

]]> 25 2019-11-05 Reported to Senate 2021-09-13T16:42:55Z Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs.

The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug.

The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval.

The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients.

The FDA must establish a user fee program for OTC drugs.

]]> 55 2019-12-10 Passed Senate 2021-09-13T16:43:19Z Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs.

The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug.

The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval.

The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients.

The FDA must establish a user fee program for OTC drugs.

]]> Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 Display Title Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 Short Title(s) as Introduced Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 Introduced in Senate IS Short Title(s) as Introduced for portions of this bill Over-the-Counter Monograph User Fee Act of 2019 Introduced in Senate IS Short Title(s) as Passed Senate Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 S Senate Engrossed in Senate ES Short Title(s) as Passed Senate for portions of this bill Over-the-Counter Monograph User Fee Act of 2019 S Senate Engrossed in Senate ES Short Title(s) as Reported to Senate for portions of this bill Over-the-Counter Monograph User Fee Act of 2019 S Senate Reported to Senate RS Short Title(s) as Reported to Senate Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 S Senate Reported to Senate RS Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application, and for other purposes. Introduced in Senate IS Short Titles as Passed Senate for portions of this bill Over-the-Counter Monograph User Fee Act of 2019 S Senate Short Titles as Passed Senate Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 S Senate Referred in House 2019-12-11T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s2740rfh/xml/BILLS-116s2740rfh.xml Engrossed in Senate 2019-12-10T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s2740es/xml/BILLS-116s2740es.xml Reported to Senate 2019-11-05T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s2740rs/xml/BILLS-116s2740rs.xml Introduced in Senate 2019-10-30T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-116s2740is/xml/BILLS-116s2740is.xml 2019-12-14 Referred to the Subcommittee on Health. 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.