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Drug Shortages Prevention and Quality Improvement Act
Legislative Progress
Momentum (last 30 days)
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0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
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0d open
vs 5,357 other S bills in the 117th — cohort avg 38d
Drug Shortages Prevention and Quality Improvement Act This bill addresses shortages of essential drugs and related issues. (Generally, an essential drug is one that is life-supporting, life-sustaining, or intended to treat or prevent a debilitating condition.) The Food and Drug Administration (FDA) may require a manufacturer of an essential drug to (1) submit data, or conduct studies to gather data, to determine the longest supported expiration date of a drug; or (2) make labeling changes regarding a drug's expiration period based on data provided under this bill or otherwise available to the FDA. The bill establishes civil monetary penalties for a manufacturer that (1) refuses such a request to provide data or modify a drug label's expiration information, or (2) fails to meet certain requirements to provide to the FDA timely information about essential drug shortages. The Government Accountability Office must conduct a study examining the process by which prescription drug manufacturers provide shelf life data to the FDA. The FDA must establish a pilot program to assess the facilities and processes of participating manufacturers of prescription sterile injectable drugs that have been deemed essential under a specified executive order. The assessment shall cover topics including supply chain management, manufacturing strategy and operations, and workforce management. Furthermore, the FDA must provide grants to certain nonprofit entities and institutions of higher education that agree to participate in the above pilot program. The grant funds must be used to upgrade the recipient's drug manufacturing facilities to utilize advanced manufacturing capabilities.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (4)
2022 · fourth_quarter · Health Issues
- Support for H.R.4555, the Oral Health Literacy and Awareness Act to authorize the Health Resources and Services Administration (HRSA) to implement an evidence-based education campaign to promote oral health literacy among vulnerable populations over a five-year period. - Support for the PREVENT Pandemics Act (S 3799) that would address a number of drug and supply shortages - Support for HR 675 that would empower Attorneys General and their relevant agencies to go after unscrupulous vendors who price gouge during critical events such as national pandemics - Support for S 2595 that would provide grants to manufacturers of critical drugs such as sterile injectables to invest in quality management and ensure extensive and consistent availability of such drugs. -Support for Senate passage of the Oral Health Literacy and Awareness Act of 2022 (S 5073), which would authorize the Health Resources and Services Administration (HRSA) to establish an evidence-based education campaign to promote oral health literacy (OHL) among the at-risk populations served by HRSA programs. - Expressing concern to the White House about Emergency Department overcrowding.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $30,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2022 · third_quarter · Health Issues
- Support for H.R.4555, the Oral Health Literacy and Awareness Act to authorize the Health Resources and Services Administration (HRSA) to implement an evidence-based education campaign to promote oral health literacy among vulnerable populations over a five-year period. - Support for the PREVENT Pandemics Act (S 3799) that would address a number of drug and supply shortages - Support for HR 675 that would empower Attorneys General and their relevant agencies to go after unscrupulous vendors who price gouge during critical events such as national pandemics - Support for S 2595 that would provide grants to manufacturers of critical drugs such as sterile injectables to invest in quality management and ensure extensive and consistent availability of such drugs.
Client expense: $40,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
- Support for H.R.4555, the Oral Health Literacy and Awareness Act. This bipartisan bill would authorize the Health Resources and Services Administration (HRSA) to implement an evidence-based education campaign to promote oral health literacy among vulnerable populations over a five-year period. - Support for the PREVENT Pandemics Act (S 3799) that would address a number of drug and supply shortages - Support for HR 675 that would empower Attorneys General and their relevant agencies to go after unscrupulous vendors who price gouge during critical events such as national pandemics - Support for S 2595 that would provide grants to manufacturers of critical drugs such as sterile injectables to invest in quality management and ensure extensive and consistent availability of such drugs.
Client expense: $60,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2022 · first_quarter · Health Issues
- Support for the Oral Health Literacy Awareness Act (HR 4555) that would develop and test evidence-based oral health literacy strategies capable of reaching across vulnerable populations to provide oral disease prevention education through a 5-year oral health literacy campaign. - A request to the FDA to include AAOMS patient resources on dental implants on their dental implant webpage. - Support for the PREVENT Pandemics Act (S 3799) that would address a number of drug and supply shortages - Support for HR 675 that would empower Attorneys General and their relevant agencies to go after unscrupulous vendors who price gouge during critical events such as national pandemics - Support for S 2595 that would provide grants to manufacturers of critical drugs such as sterile injectables to invest in quality management and ensure extensive and consistent availability of such drugs.
Client expense: $100,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2021 · third_quarter · Health Issues
Discussions pertaining to CMS rulemaking on surprise billing ban S 748 Medicare Sequester Relief Act (all sections of full text) HR 2547 Comprehensive Debt Collection Improvement Act (all sections of full text) Monitored CFPB actions that may limit providers ability to recoup patient medical debt Monitored S 2061 Telemental Health Care Access Act of 2021 Monitored HR 4058 Telemental Health Care Access Act of 2021 Monitored S 368 Telehealth Modernization Act Monitored HR 1332 Telehealth Modernization Act Monitored S 155 Equal Access to Care Act Monitored HR 688 Equal Access to Care Act Monitored S 168 TREAT Act Monitored HR 708 TREAT Act Monitored S 2595 Drug Shortages Prevention and Quality Improvement Act Monitored discussions pertinent to health care group purchasing organizations (GPOs) Monitored S 2164 The Lower Costs, More Cures Act Monitored HR 5376 Build Back Better Act Monitored HR 4390 PROTECT 340B Act of 2021 Monitored discussions of 340B Drug Pricing Program Monitored President's Executive Order 14036 on Promoting Competition in the American Economy Monitored Executive Branch action reports and consultations associated with Executive Order 14017 on America's supply chains Monitored nominations to executive branch agencies and federally authorized commissions Monitored CMS price transparency rule for hospitals, Public Health Service Act Section 2718(e) Monitored implementation of Sec. 6001 of the Affordable Care Act of 2010
Client expense: Not reported · Firm income: $130,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Health Issues
S 1568 Technical Reset to Advance the Instruction of Nurses Act or the TRAIN Act (all sections of full text) S 2428 False Claims Amendments Act of 2021 (all sections of full text) S 3314 Supporting Medicare Providers Act of 2021 (all sections of full text) HR 6020 Supporting Medicare Providers Act of 2021 (all sections of full text) Discussions pertaining to CMS rulemaking on surprise billing ban Discussions involving CMS proposed Physician Fee Schedule S 748 Medicare Sequester Relief Act (all sections of full text) HR 2547 Comprehensive Debt Collection Improvement Act (all sections of full text) HR 4350 National Defense Authoriation Act for FY 2022, Section 5107 Monitored CFPB actions that may limit providers ability to recoup patient medical debt Monitored S 2061 Telemental Health Care Access Act of 2021 Monitored HR 4058 Telemental Health Care Access Act of 2021 Monitored S 368 Telehealth Modernization Act Monitored HR 1332 Telehealth Modernization Act Monitored S 155 Equal Access to Care Act Monitored HR 688 Equal Access to Care Act Monitored S 2595 Drug Shortages Prevention and Quality Improvement Act Monitored discussions pertinent to health care group purchasing organizations (GPOs) Monitored HR 4390 PROTECT 340B Act of 2021 Monitored discussions of 340B Drug Pricing Program Monitored Executive Branch action reports and consultations associated with Executive Order 14017 on America's supply chains Monitored nominations to executive branch agencies and federally authorized commissions Monitored CMS price transparency rule for hospitals, Public Health Service Act Section 2718(e)
Client expense: Not reported · Firm income: $130,000
2021 · fourth_quarter · Energy/Nuclear
Home Energy Savings Act; S. 2588 and H.R. 4506 These pieces of legislation are an ACCA priority and require HVAC systems to be properly installed. New Home Energy Savings Act; S. 2595 These pieces of legislation are an ACCA priority and require HVAC systems to be properly installed.
Client expense: Not reported · Firm income: Not reported
Government targets: Council on Environmental Quality (CEQ), Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), SENATE, Small Business Administration (SBA)
2021 · third_quarter · Energy/Nuclear
Home Energy Savings Act; S. 2588 and H.R. 4506 These pieces of legislation are an ACCA priority and require HVAC systems to be properly installed. New Home Energy Savings Act; S. 2595 These pieces of legislation are an ACCA priority and require HVAC systems to be properly installed.
Client expense: Not reported · Firm income: Not reported
Government targets: Council on Environmental Quality (CEQ), Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), SENATE, Small Business Administration (SBA)
2021 · third_quarter · Health Issues
S. 2595 - Drug Shortages Prevention and Quality Improvement Act: Provisions related to the advance manufacturing grant program. 21st Century Cures Act 2.0, discussion draft: Provisions related to Compounding and Drug Pricing. American Rescue Plan Act (P.L. 117-2): Provisions related to implementation of supply chain reform and COVID-19 pandemic response. FY 2022 Appropriations: Provisions related to Cannabis and Infrastructure and budget reconciliation legislation. Cannabis Opportunity and Administration, discussion draft: Provisions related to quality standards for cannabis and hemp.
Client expense: $90,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · third_quarter · Health Issues
Discussions pertaining to CMS rulemaking on surprise billing ban S 748 Medicare Sequester Relief Act (all sections of full text) HR 2547 Comprehensive Debt Collection Improvement Act (all sections of full text) Monitored CFPB actions that may limit providers ability to recoup patient medical debt Monitored S 2061 Telemental Health Care Access Act of 2021 Monitored HR 4058 Telemental Health Care Access Act of 2021 Monitored S 368 Telehealth Modernization Act Monitored HR 1332 Telehealth Modernization Act Monitored S 155 Equal Access to Care Act Monitored HR 688 Equal Access to Care Act Monitored S 168 TREAT Act Monitored HR 708 TREAT Act Monitored S 2595 Drug Shortages Prevention and Quality Improvement Act Monitored discussions pertinent to health care group purchasing organizations (GPOs) Monitored S 2164 The Lower Costs, More Cures Act Monitored HR 5376 Build Back Better Act Monitored HR 4390 PROTECT 340B Act of 2021 Monitored discussions of 340B Drug Pricing Program Monitored President's Executive Order 14036 on Promoting Competition in the American Economy Monitored Executive Branch action reports and consultations associated with Executive Order 14017 on America's supply chains Monitored nominations to executive branch agencies and federally authorized commissions Monitored CMS price transparency rule for hospitals, Public Health Service Act Section 2718(e) Monitored implementation of Sec. 6001 of the Affordable Care Act of 2010
Client expense: Not reported · Firm income: $130,000
2021 · second_quarter · Energy/Nuclear
Home Energy Savings Act; S. 2588 and H.R. 4506 These pieces of legislation are an ACCA priority and require HVAC systems to be properly installed. New Home Energy Savings Act; S. 2595 These pieces of legislation are an ACCA priority and require HVAC systems to be properly installed.
Client expense: Not reported · Firm income: Not reported
Government targets: Council on Environmental Quality (CEQ), Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), SENATE, Small Business Administration (SBA)
2021 · first_quarter · Energy/Nuclear
Home Energy Savings Act; S. 2588 and H.R. 4506 These pieces of legislation are an ACCA priority and require HVAC systems to be properly installed. New Home Energy Savings Act; S. 2595 These pieces of legislation are an ACCA priority and require HVAC systems to be properly installed.
Client expense: Not reported · Firm income: Not reported
Government targets: Council on Environmental Quality (CEQ), Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Labor, Dept of (DOL), Natl Labor Relations Board (NLRB), SENATE, Small Business Administration (SBA)
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE