Loading…
To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
79pct
30d open
vs 9,062 other HR bills in the 116th — cohort avg 39d
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.
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 (10)
Sponsor introductory remarks on measure. (CR E971)
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2020 · fourth_quarter · Pharmacy
S. 1895, Lower Health Care Costs Act, with specific regard for provision on generic drug labeling. S. 3519, MODERN Labeling Act. H.R. 3443, Over-the-counter Monograph Safety, Innovation, and Reform Act of 2019. S. 3872, Promising Pathway Act. H.R. 7269, Promising Pathway Act. General lobbying with regard to FDA preemption. General lobbying with regard to labeling requirements.
Client expense: $1,110,000 · Firm income: Not reported
Government targets: Federal Trade Commission (FTC), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)
2020 · fourth_quarter · Manufacturing
H.R.269 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 -- To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. H.R.648 - Consolidated Appropriations Act, 2019 -- Making appropriations for the fiscal year ending September 30, 2019, and for other purposes. Includes language authorizing the collection of Monograph Reform user fees. H.J.Res.28 - Further Additional Continuing Appropriations Act, 2019 - This joint resolution provides continuing FY2019 appropriations to several federal agencies through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. H.J.Res.31 - Consolidated Appropriations Act, 2019 -- This joint resolution provides continuing FY2019 appropriations for the Department of Homeland Security (DHS) through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. It is known as a continuing resolution (CR) and ends the partial DHS shutdown that began on December 22, 2018, because the existing CR expired and the FY2019 DHS appropriations bill has not been enacted. H.R.268 - Supplemental Appropriations Act, 2019 -- This bill provides $12.1 billion in FY2019 supplemental appropriations to several federal departments and agencies for expenses related to the consequences of recent wildfires, hurricanes, volcanos, earthquakes, typhoons, and other natural disasters. S.726 - Personal Care Products Safety Act -- To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. Cosmetic Safety Enhancement Act of 2019 (Pallone/Shimkus discussion draft) -- To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic safety, and for other purposes H.R.3443 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 S.1895 - Lower Health Care Costs Act S.2522 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 H.R.4296 - Safe Cosmetics and Personal Care Products Act of 2019 Udall/Lowenthal consumer products plastics outline, proposal to address consumer plastics issues. No bill number. H.R.2296/S.1391 - More Efficient Tools to Realize Information for Consumers Act S.2740 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 H.R.1865 - Further Consolidated Appropriations Act, 2020 H.R.5279 - Cosmetic Safety Enhancement Act of 2019 21st Century Cures Act 2.0 (No bill number) H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes. S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 H.R.748 - CARES Act Critical infrastructure and supply chain HR 8837 -- Continuing Appropriations Act, 2021 and Other Extensions Act H.R.133 - Consolidated Appropriations Act, 2021
Client expense: $146,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE, Treasury, Dept of, Vice President of the U.S.
2020 · third_quarter · Pharmacy
S. 1895, Lower Health Care Costs Act, with specific regard for provision on generic drug labeling. S. 3519, MODERN Labeling Act. H.R. 3443, Over-the-counter Monograph Safety, Innovation, and Reform Act of 2019. S. 3872, Promising Pathway Act. H.R. 7269, Promising Pathway Act. General lobbying with regard to FDA preemption. General lobbying with regard to labeling requirements.
Client expense: $1,400,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)
2020 · third_quarter · Manufacturing
H.R.269 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 -- To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. H.R.648 - Consolidated Appropriations Act, 2019 -- Making appropriations for the fiscal year ending September 30, 2019, and for other purposes. Includes language authorizing the collection of Monograph Reform user fees. H.J.Res.28 - Further Additional Continuing Appropriations Act, 2019 - This joint resolution provides continuing FY2019 appropriations to several federal agencies through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. H.J.Res.31 - Consolidated Appropriations Act, 2019 -- This joint resolution provides continuing FY2019 appropriations for the Department of Homeland Security (DHS) through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. It is known as a continuing resolution (CR) and ends the partial DHS shutdown that began on December 22, 2018, because the existing CR expired and the FY2019 DHS appropriations bill has not been enacted. H.R.268 - Supplemental Appropriations Act, 2019 -- This bill provides $12.1 billion in FY2019 supplemental appropriations to several federal departments and agencies for expenses related to the consequences of recent wildfires, hurricanes, volcanos, earthquakes, typhoons, and other natural disasters. S.726 - Personal Care Products Safety Act -- To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. Cosmetic Safety Enhancement Act of 2019 (Pallone/Shimkus discussion draft) -- To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic safety, and for other purposes H.R.3443 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 S.1895 - Lower Health Care Costs Act S.2522 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 H.R.4296 - Safe Cosmetics and Personal Care Products Act of 2019 Udall/Lowenthal consumer products plastics outline, proposal to address consumer plastics issues. No bill number. H.R.2296/S.1391 - More Efficient Tools to Realize Information for Consumers Act S.2740 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 H.R.1865 - Further Consolidated Appropriations Act, 2020 H.R.5279 - Cosmetic Safety Enhancement Act of 2019 21st Century Cures Act 2.0 (No bill number) H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes. S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 H.R.748 - CARES Act Critical infrastructure and supply chain HR 8837 -- Continuing Appropriations Act, 2021 and Other Extensions Act
Client expense: $140,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE, Treasury, Dept of, Vice President of the U.S.
2020 · first_quarter · Medical/Disease Research/Clinical Labs
Over the counter drug approval process for sunscreen ingredients; Implementation of Public Law 113-195, the Sunscreen Innovation Act; House and Senate FY 2021 Ag-FDA Appropriations bills and reports; Sunscreen use in schools; Sunscreen provisions in H.R. 3443 and S.2740, Over-the-Counter Monograph Safety, Innovation and Reform Act of 2019; Issues related to state bans on sunscreen ingredients; Issues related to sunscreen use and coral reefs.
Client expense: Not reported · Firm income: $60,000
Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Oceanic & Atmospheric Administration (NOAA), SENATE
2020 · second_quarter · Pharmacy
General issues related to over the counter pharmaceuticals and pharmaceutical supply chain. H.R. 3443/S.2740, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019. H.R. 748, Coronavirus Aid, Relief, and Economic Security Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Health Issues
Issues related to the over the counter drug monograph process including H. R. 3443/S.2740, the Over-the-counter Monograph Safety, Innovation, and Reform Act of 2019. Issues related to sunscreen. H.R. 748, Coronavirus Aid, Relief, and Economic Security Act. H.R. 5279, Cosmetic Safety Enhancement Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Pharmacy
S. 1895, Lower Health Care Costs Act, with specific regard for provision on generic drug labeling. S. 3519, MODERN Labeling Act. H.R. 3443, Over-the-counter Monograph Safety, Innovation, and Reform Act of 2019. S. 3872, Promising Pathway Act. House version of the Promising Pathway Act (no bill number yet, but has been introduced). General lobbying with regard to FDA preemption. General lobbying with regard to labeling requirements.
Client expense: $1,350,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Manufacturing
H.R.269 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 -- To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. H.R.648 - Consolidated Appropriations Act, 2019 -- Making appropriations for the fiscal year ending September 30, 2019, and for other purposes. Includes language authorizing the collection of Monograph Reform user fees. H.J.Res.28 - Further Additional Continuing Appropriations Act, 2019 - This joint resolution provides continuing FY2019 appropriations to several federal agencies through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. H.J.Res.31 - Consolidated Appropriations Act, 2019 -- This joint resolution provides continuing FY2019 appropriations for the Department of Homeland Security (DHS) through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. It is known as a continuing resolution (CR) and ends the partial DHS shutdown that began on December 22, 2018, because the existing CR expired and the FY2019 DHS appropriations bill has not been enacted. H.R.268 - Supplemental Appropriations Act, 2019 -- This bill provides $12.1 billion in FY2019 supplemental appropriations to several federal departments and agencies for expenses related to the consequences of recent wildfires, hurricanes, volcanos, earthquakes, typhoons, and other natural disasters. S.726 - Personal Care Products Safety Act -- To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. Cosmetic Safety Enhancement Act of 2019 (Pallone/Shimkus discussion draft) -- To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic safety, and for other purposes H.R.3443 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 S.1895 - Lower Health Care Costs Act S.2522 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 H.R.4296 - Safe Cosmetics and Personal Care Products Act of 2019 Udall/Lowenthal consumer products plastics outline, proposal to address consumer plastics issues. No bill number. H.R.2296/S.1391 - More Efficient Tools to Realize Information for Consumers Act S.2740 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 H.R.1865 - Further Consolidated Appropriations Act, 2020 H.R.5279 - Cosmetic Safety Enhancement Act of 2019 21st Century Cures Act 2.0 (No bill number) H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes. S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 H.R.748 - CARES Act Critical infrastructure and supply chain
2020 · first_quarter · Medical/Disease Research/Clinical Labs
Over the counter drug approval process for sunscreen ingredients; Implementation of Public Law 113-195, the Sunscreen Innovation Act; House and Senate FY 2021 Ag-FDA Appropriations bills and reports; Sunscreen use in schools; Sunscreen provisions in H.R. 3443 and S.2740, Over-the-Counter Monograph Safety, Innovation and Reform Act of 2019; Issues related to state bans on sunscreen ingredients; Issues related to sunscreen use and coral reefs.
Client expense: Not reported · Firm income: $50,000
Government targets: Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Oceanic & Atmospheric Administration (NOAA), SENATE
2020 · first_quarter · Health Issues
Issues regarding access to dental services. Monitored H.R. 1835, Consensual Donation and Research Integrity Act of 2019. S. 1895, Lower Health Care Costs Act of 2019, H.R. 2328, Reauthorizing and Extending Americas Community Health Act and issues regarding surprise billing and exempt benefits. H.R. 3630, No Surprises Act. S.2740 / H.R.3443, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019. Coronavirus Aid, Relief and Economic Security "CARES Act," P.L. 116-136, as it relates to over-the-counter monograph safety and surprise billing. Monitored issues related to Indian Health Services. H.R.1379, the Ensuring Lasting Smiles Act. Monitored issues related to H.R. 5800, Ban Surprise Billing Act. Monitored issues related to H.R. 2339, the Reversing the Youth Tobacco Epidemic Act of 2019. Monitored issues related to Section 1557 of the Patient Protection and Affordable Care Act.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), SENATE, Treasury, Dept of
2020 · first_quarter · Pharmacy
S. 1895, Lower Health Care Costs Act, with specific regard for provision on generic drug labeling. S. 3519, MODERN Labeling Act. H.R. 3443, Over-the-counter Monograph Safety, Innovation, and Reform Act of 2019. General lobbying with regard to FDA preemption. General lobbying with regard to labeling requirements.
Client expense: $1,370,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)
2020 · first_quarter · Manufacturing
H.R.269 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 -- To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. H.R.648 - Consolidated Appropriations Act, 2019 -- Making appropriations for the fiscal year ending September 30, 2019, and for other purposes. Includes language authorizing the collection of Monograph Reform user fees. H.J.Res.28 - Further Additional Continuing Appropriations Act, 2019 - This joint resolution provides continuing FY2019 appropriations to several federal agencies through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. H.J.Res.31 - Consolidated Appropriations Act, 2019 -- This joint resolution provides continuing FY2019 appropriations for the Department of Homeland Security (DHS) through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. It is known as a continuing resolution (CR) and ends the partial DHS shutdown that began on December 22, 2018, because the existing CR expired and the FY2019 DHS appropriations bill has not been enacted. H.R.268 - Supplemental Appropriations Act, 2019 -- This bill provides $12.1 billion in FY2019 supplemental appropriations to several federal departments and agencies for expenses related to the consequences of recent wildfires, hurricanes, volcanos, earthquakes, typhoons, and other natural disasters. S.726 - Personal Care Products Safety Act -- To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. Cosmetic Safety Enhancement Act of 2019 (Pallone/Shimkus discussion draft) -- To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic safety, and for other purposes H.R.3443 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 S.1895 - Lower Health Care Costs Act S.2522 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 H.R.4296 - Safe Cosmetics and Personal Care Products Act of 2019 Udall/Lowenthal consumer products plastics outline, proposal to address consumer plastics issues. No bill number. H.R.2296/S.1391 - More Efficient Tools to Realize Information for Consumers Act S.2740 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 H.R.1865 - Further Consolidated Appropriations Act, 2020 H.R.5279 - Cosmetic Safety Enhancement Act of 2019 21st Century Cures Act 2.0 (No bill number) H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes. S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019 H.R.748 - CARES Act Critical infrastructure and supply chain
2020 · first_quarter · Health Issues
Issues related to the over the counter drug monograph process including H. R. 3443/S.2740, the Over-the-counter Monograph Safety, Innovation, and Reform Act of 2019. Issues related to sunscreen. H.R. 748, Coronavirus Aid, Relief, and Economic Security Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · first_quarter · Pharmacy
General issues related to over the counter pharmaceuticals. Issues related to draft legislation addressing the over the counter drug monograph process including H. R. 3443/S2740, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019. H.R. 748, Coronavirus Aid, Relief, and Economic Security Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · first_quarter · Health Issues
H.R. 748 - CARES Act - Issues related to supporting the national work fighting COVID-19 and ensuring that antibiotics are available during the COVID-19 crisis and beyond and OTC monograph reform is address to enhance patient safety. H.R. 6201 - Families First Coronavirus Response Act - Issues related to ensuring that the federal government is best supporting the public good with a focus on ensuring there is a strong antibiotics pipeline to fight secondary infections and over the counter medications are safe and secure. H.R. 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020 - Issues related to supporting programs and institutions supporting during the current pandemic. S. 1712/H.R. 4100 - THe DISARM Act - Support for ensuring that there are sufficient antibiotics in the pipeline to meet the national need. H.R. 2482 - The Mainstreaming Addiction Treatment Act of 2019 - Support for policies increasing the ability to access MAT to treat addiction. H.R. 3443 - The OTC Monograph Safety Innovation and Reform Act of 2019 - Support for policies that enable OTC monograph reform. Regulations promulgated by ONC and HHS related to patient matching, interoperability, unique patient identifiers, unique device identifiers and other HIT tools that can support better patient safety in our healthcare system. Issues related to creating a listing mechanism for dietary supplements. Issues related to the implementation on the SUPPORT Act (P.L. 115-271)
Client expense: Not reported · Firm income: $60,000
2020 · first_quarter · Pharmacy
H.R. 748 - CARES Act - Issues related to supporting the national work fighting COVID-19 and ensuring that antibiotics are available during the COVID-19 crisis and beyond and OTC monograph reform is address to enhance patient safety. H.R. 6201 - Families First Coronavirus Response Act - Issues related to ensuring that the federal government is best supporting the public good with a focus on ensuring there is a strong antibiotics pipeline to fight secondary infections and over the counter medications are safe and secure. H.R. 6074 - Coronavirus Preparedness and Response Supplemental Appropriations Act of 2020 - Issues related to supporting programs and institutions supporting during the current pandemic. S. 1712/H.R. 4100 - THe DISARM Act - Support for ensuring that there are sufficient antibiotics in the pipeline to meet the national need. H.R. 2482 - The Mainstreaming Addiction Treatment Act of 2019 - Support for policies increasing the ability to access MAT to treat addiction. H.R. 3443 - The OTC Monograph Safety Innovation and Reform Act of 2019 - Support for policies that enable OTC monograph reform. Issues related to creating a listing mechanism for dietary supplements. Issues related to the implementation on the SUPPORT Act (P.L. 115-271) S. 1712/H.R. 4100 - THe DISARM Act - Support for ensuring that there are sufficient antibiotics in the pipeline to meet the national need. H.R. 2482 - The Mainstreaming Addiction Treatment Act of 2019 - Support for policies increasing the ability to access MAT to treat addiction.
Client expense: Not reported · Firm income: $60,000
2019 · fourth_quarter · Consumer Issues/Safety/Products
H.R. 1816, Children's Product Warning Label Act of 2019; H.R. 5017, Natural Cosmetics Act; H.R. 5279, Cosmetic Safety Enhancement Act; H.R. 4296, Safe Cosmetics and Personal Care Products Act of 2019 H.R. 5141/S. 2886, Humane Cosmetics Act - Issues related to regulation of cosmetic animal testing S. 2740/H.R. 3443, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 Combating Counterfeits draft legislation
Client expense: $300,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2019 · fourth_quarter · Pharmacy
S. 1895, Lower Health Care Costs Act, with specific regard for provision on generic drug labeling. S. 3519, MODERN Labeling Act. H.R. 3443, Over-the-counter Monograph Safety, Innovation, and Reform Act of 2019. General lobbying with regard to FDA preemption. General lobbying with regard to labeling requirements.
Client expense: $1,300,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)
2019 · fourth_quarter · Health Issues
Issues related to the over the counter drug monograph process including H. R. 3443/S.2740, the Over-the-counter Monograph Safety, Innovation, and Reform Act of 2019. Issues related to sunscreen. H. R. 1865, the Further Consolidated Appropriations Act of 2020.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · fourth_quarter · Pharmacy
General issues related to over the counter pharmaceuticals. Issues related to draft legislation addressing the over the counter drug monograph process including H. R. 3443/S2740, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019. H. R. 1865, the Further Consolidated Appropriations Act of 2020.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · fourth_quarter · Manufacturing
H.R.269 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 -- To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. H.R.648 - Consolidated Appropriations Act, 2019 -- Making appropriations for the fiscal year ending September 30, 2019, and for other purposes. Includes language authorizing the collection of Monograph Reform user fees. H.J.Res.28 - Further Additional Continuing Appropriations Act, 2019 - This joint resolution provides continuing FY2019 appropriations to several federal agencies through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. H.J.Res.31 - Consolidated Appropriations Act, 2019 -- This joint resolution provides continuing FY2019 appropriations for the Department of Homeland Security (DHS) through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. It is known as a continuing resolution (CR) and ends the partial DHS shutdown that began on December 22, 2018, because the existing CR expired and the FY2019 DHS appropriations bill has not been enacted. H.R.268 - Supplemental Appropriations Act, 2019 -- This bill provides $12.1 billion in FY2019 supplemental appropriations to several federal departments and agencies for expenses related to the consequences of recent wildfires, hurricanes, volcanos, earthquakes, typhoons, and other natural disasters. S.726 - Personal Care Products Safety Act -- To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. Cosmetic Safety Enhancement Act of 2019 (Pallone/Shimkus discussion draft) -- To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic safety, and for other purposes H.R.3443 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 S.1895 - Lower Health Care Costs Act S.2522 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 H.R.4296 - Safe Cosmetics and Personal Care Products Act of 2019 Udall/Lowenthal consumer products plastics outline, proposal to address consumer plastics issues. No bill number. H.R.2296/S.1391 - More Efficient Tools to Realize Information for Consumers Act S.2740 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 H.R.1865 - Further Consolidated Appropriations Act, 2020 H.R.5279 - Cosmetic Safety Enhancement Act of 2019 21st Century Cures Act 2.0 (No bill number) H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes. S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019
2019 · fourth_quarter · Medical/Disease Research/Clinical Labs
Over the counter drug approval process for sunscreen ingredients; Implementation of Public Law 113-195, the Sunscreen Innovation Act; House and Senate FY 2020 Ag-FDA Appropriations bills and reports (H.R. 3164 & S.2522); Sunscreen use in schools; Sunscreen provisions in H.R. 3443 and S.2740, Over-the-Counter Monograph Safety, Innovation and Reform Act of 2019; Issues related to state bans on sunscreen ingredients.
Client expense: Not reported · Firm income: $70,000
Government targets: Centers For Disease Control & Prevention (CDC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2019 · fourth_quarter · Health Issues
Support H.R. 2862 the Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019. Support S. 1944/H.R. 3447, the Public Health Funding Restoration Act. Support H.R. 2507, the Newborn Screening Saves Lives Reauthorization Act of 2019. Support H.R. 3443, the bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act. Support Community Access, Resources, and Education for Families (CARE for Families) Act. Support S. 916/H.R. 1897, the Mothers and Offspring Mortality and Morbidity Awareness (MOMMA) Act. Support H.R. 1551/S.1960, the Quality Care for Moms and Babies Act. Support S.1895, the Lower Health Care Costs Act. Support H.R. 4996 Helping Medicaid Offer Maternity Services Act of 2019.
Client expense: $19,878 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2019 · fourth_quarter · Pharmacy
S. 1712/H.R. 4100 - THe DISARM Act - Support for ensuring that there are sufficient antibiotics in the pipeline to meet the national need. H.R. 2482 - The Mainstreaming Addiction Treatment Act of 2019 - Support for policies increasing the ability to access MAT to treat addiction. H.R. 3443 - The OTC Monograph Safety Innovation and Reform Act of 2019 - Support for policies that enable OTC monograph reform. Issues related to the implementation on the SUPPORT Act (P.L. 115-271) regarding MAT treatment. Issues related to curbing antibiotic resistance.
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · fourth_quarter · Health Issues
S. 1712/H.R. 4100 - THe DISARM Act - Support for ensuring that there are sufficient antibiotics in the pipeline to meet the national need. H.R. 2482 - The Mainstreaming Addiction Treatment Act of 2019 - Support for policies increasing the ability to access MAT to treat addiction. H.R. 3443 - The OTC Monograph Safety Innovation and Reform Act of 2019 - Support for policies that enable OTC monograph reform. Regulations promulgated by ONC and HHS related to patient matching, interoperability, unique patient identifiers, unique device identifiers and other HIT tools that can support better patient safety in our healthcare system. Issues related to creating a listing mechanism for dietary supplements. Issues related to the implementation on the SUPPORT Act (P.L. 115-271)
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · third_quarter · Health Issues
H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation ___ H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation ___ H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1922/S. 1089 _ Restoring Access to Medicine Act ___ H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing ___ H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency ___ H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1973: Vaccine Access Improvement Act ___ H.R. 2011: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products ___ H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing ___ H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples ___ H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs ___ H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency ___ H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples ___ H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency ___ H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ H.R. 2401: American Cures Act - Provisions related to pharmaceutical research and development ___ H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising ___ H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency ___ H.R. 3443: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 - Provisions related to FDA over-the-counter drug approvals ___ H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions ___ H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising ___ H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency ___ H.R. 4538: To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. - Provisions related to 340B prescription drug exclusions ___ S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation ___ S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising ___ S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation ___ S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems ___ S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing ___ S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes ___ S. 474: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs ___ S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency ___ S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates ___ S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals ___ S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process ___ S. 844: Short on Competition Act - Provisions related to generic prescription drug approvals and importation ___ S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing ___ S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products ___ S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates ___ S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency ___ S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising ___ S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers ___ S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S.1872 _ Protecting Seniors through Immunizations Act of 2019 ___ S. 2387: We Protect American Investment in Drugs Act - Provisions related to prescription drug pricing ___ Transparency policy issues ___ Drug cost and pricing policy issues ___ Drug importation and counterfeiting policy issues ___ HHS Safe Importation Action Plan ___ Prescription drug take back and secure disposal policy issues ___ Policy issues related to prescription drug abuse and opioids ___ Expanded access policy issues ___ Generic drug approval process policy issues ___ High deductible health plans/HSA policy issues ___ Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors ___ Risk Evaluation and Mitigation Strategy (REMS) policy issues ___ FDA modernization policy issues ___ PDUFA implementation policy issues ___ 340B drug discount program policy issues ___ Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions ___ Patient assistance program policy issues ___ Biosimilar approval and reimbursement policy issues ___ Cancer drug vial size policy issues ___ TRICARE pharmacy pilot program ___ Drug shortages policy issues ___ Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
2019 · third_quarter · Health Issues
H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release (FAIR) of Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2296: FAIR Drug Pricing Act of 2019 / More Efficient Tools to Realize Information for Consumers Act - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2401: American Cures Act - Provisions related to pharmaceutical research and development H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: Drug Price Transparency for Medicare Patients Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 3415: Real-Time Beneficiary Drug Cost Bill - Provisions related to drug pricing transparency H.R. 3443: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 - Provisions related to FDA over-the-counter drug approvals H.R. 3947: Competition Prescription Act of 2019 - Provisions related to prescription drug pricing, patents, and other provisions H.R. 4106: Responsibility in Drug Advertising Act of 2019 - Provisions related to direct-to-consumer prescription drug advertising H.R. 4158: CURE High Drug Prices Act - Provisions related to prescription drug pricing and transparency H.R. 4538: To amend title III of the Public Health Service Act to limit the orphan drug exclusion under the drug discount program under section 340B of such title. - Provisions related to 340B prescription drug exclusions S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 474: Stopping the Pharmaceutical Industry from Keeping Drugs Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 844: Short on Competition Act - Provisions related to generic prescription drug approvals and importation S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency S. 2103: Affordable Insulin Approvals Now Act - Provisions related to FDA prescription drug approvals S. 2161: Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 - Provisions related to reciprocity S. 2199: Insulin Price Reduction Act - Provisions related to prescription drug pricing and transparency S. 2387: We Protect American Investment in Drugs Act - Provisions related to prescription drug pricing Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues HHS Safe Importation Action Plan Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues PDUFA implementation policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
2019 · third_quarter · Health Issues
Support H.R. 986, the Protecting Americans with Pre-Existing Conditions Act of 2019. Support H.R. 987, the Strengthening Health Care and Prescription Drug Costs Act. Support H.R. 2862 the Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019. Support S. 1944/H.R. 3447, the Public Health Funding Restoration Act. Expressed concerns with provisions in S. 696/H.R.1597, the National Nurse Act of 2019. Support H.R. 2507, the Newborn Screening Saves Lives Reauthorization Act of 2019. Support H.R. 3443, the bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act. Support Community Access, Resources, and Education for Families (CARE for Families) Act. Support H.R. 2822, the Family-to-Family Reauthorization Act of 2019. Support S. 916/H.R. 1897, the Mothers and Offspring Mortality and Morbidity Awareness (MOMMA) Act. Support H.R. 1329: the Medicaid Reentry Act. Support H.R. 3080, the Comprehensive TB Elimination Act of 2019. Support H.R. 1551/S.1960, the Quality Care for Moms and Babies Act. Support S.1895, the Lower Health Care Costs Act
Client expense: $22,541 · Firm income: Not reported
2019 · third_quarter · Health Issues
Issues related to the over the counter drug monograph process including H.R.269, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 and H. R. 3443, the Over-the-counter Monograph Safety, Innovation, and Reform Act of 2019. Issues related to sunscreen.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · third_quarter · Pharmacy
General issues related to over the counter pharmaceuticals. Issues related to draft legislation addressing the over the counter drug monograph process including H.R.269 and H. R. 3443, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · third_quarter · Manufacturing
H.R.269 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 -- To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. H.R.648 - Consolidated Appropriations Act, 2019 -- Making appropriations for the fiscal year ending September 30, 2019, and for other purposes. Includes language authorizing the collection of Monograph Reform user fees. H.J.Res.28 - Further Additional Continuing Appropriations Act, 2019 - This joint resolution provides continuing FY2019 appropriations to several federal agencies through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. H.J.Res.31 - Consolidated Appropriations Act, 2019 -- This joint resolution provides continuing FY2019 appropriations for the Department of Homeland Security (DHS) through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. It is known as a continuing resolution (CR) and ends the partial DHS shutdown that began on December 22, 2018, because the existing CR expired and the FY2019 DHS appropriations bill has not been enacted. H.R.268 - Supplemental Appropriations Act, 2019 -- This bill provides $12.1 billion in FY2019 supplemental appropriations to several federal departments and agencies for expenses related to the consequences of recent wildfires, hurricanes, volcanos, earthquakes, typhoons, and other natural disasters. S.726 - Personal Care Products Safety Act -- To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. Cosmetic Safety Enhancement Act of 2019 (Pallone/Shimkus discussion draft) -- To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic safety, and for other purposes H.R.3443 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 S.1895 - Lower Health Care Costs Act S.2522 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020 H.R.4296 - Safe Cosmetics and Personal Care Products Act of 2019 Udall/Lowenthal consumer products plastics outline, proposal to address consumer plastics issues. No bill number. H.R.2296 - More Efficient Tools to Realize Information for Consumers Act
2019 · third_quarter · Health Issues
S. 1712/H.R. 4100 - THe DISARM Act - Support for ensuring that there are sufficient antibiotics in the pipeline to meet the national need. H.R. 2482 - The Mainstreaming Addiction Treatment Act of 2019 - Support for policies increasing the ability to access MAT to treat addiction. H.R. 3443 - The OTC Monograph Safety Innovation and Reform Act of 2019 - Support for policies that enable OTC monograph reform. Regulations promulgated by ONC and HHS related to patient matching, interoperability, unique patient identifiers, unique device identifiers and other HIT tools that can support better patient safety in our healthcare system. Issues related to creating a listing mechanism for dietary supplements. Issues related to the implementation on the SUPPORT Act (P.L. 115-271)
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · third_quarter · Pharmacy
S. 1712/H.R. 4100 - THe DISARM Act - Support for ensuring that there are sufficient antibiotics in the pipeline to meet the national need. H.R. 2482 - The Mainstreaming Addiction Treatment Act of 2019 - Support for policies increasing the ability to access MAT to treat addiction. H.R. 3443 - The OTC Monograph Safety Innovation and Reform Act of 2019 - Support for policies that enable OTC monograph reform. Issues related to the implementation on the SUPPORT Act (P.L. 115-271) regarding MAT treatment. Issues related to curbing antibiotic resistance.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · third_quarter · Medical/Disease Research/Clinical Labs
Over the counter drug approval process for sunscreen ingredients; Implementation of Public Law 113-195, the Sunscreen Innovation Act; House and Senate FY 2020 Ag-FDA Appropriations bills and reports (H.R. 3164 & S.2522); Sunscreen use in schools; Sunscreen provisions in H.R. 3443, Over-the-Counter Monograph Safety, Innovation and Reform Act of 2019; Issues related to state bans on sunscreen ingredients.
Client expense: Not reported · Firm income: $70,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2019 · second_quarter · Health Issues
H.R. 269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - Provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing H.R. 1730: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing H.R. 2011: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products H.R. 2020: STEER Act - Provisions related to encapsulating & tableting machine registration H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2296: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2584: To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings - Provisions related to CBO scoring of preventive health savings H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: To amend title XI of the Social Security Act to require that direct-to-consumer television advertisements for prescription drugs and biological products include the list price of such drugs and products, and for other purposes - Provisions related to direct-to-consumer prescription drug advertising H.R. 3379: Price Relief, Innovation, and Competition for Essential Drugs or PRICED Act - Provisions related to exclusivity H.R. 3408: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3415: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3443: To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes - Provisions related to FDA over-the-counter drug approvals S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 419: Protecting Americans from Dangerous Opioids Act - Provisions related to FDA drug approvals S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 474: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 741: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing S. 989: STEER Act - Provisions related to encapsulating & tableting machine registration S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
2019 · second_quarter · Health Issues
H.R. 269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - Provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing H.R. 1730: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing H.R. 1922: Restoring Access to Medicine Act H.R. 2011: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products H.R. 2020: STEER Act - Provisions related to encapsulating & tableting machine registration H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2296: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2584: To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings - Provisions related to CBO scoring of preventive health savings H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: To amend title XI of the Social Security Act to require that direct-to-consumer television advertisements for prescription drugs and biological products include the list price of such drugs and products, and for other purposes - Provisions related to direct-to-consumer prescription drug advertising H.R. 3379: Price Relief, Innovation, and Competition for Essential Drugs or PRICED Act - Provisions related to exclusivity H.R. 3408: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3415: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3443: To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes - Provisions related to FDA over-the-counter drug approvals S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S.12: Health Savings Account of 2019 S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S.182: Protecting Seniors through Immunization Act S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 474: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 741: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing S. 989: STEER Act - Provisions related to encapsulating & tableting machine registration S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S.1654/H.R. 1973: Vaccine Access Improvement Act S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
2019 · second_quarter · Manufacturing
H.R.269 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 -- To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes. H.R.648 - Consolidated Appropriations Act, 2019 -- Making appropriations for the fiscal year ending September 30, 2019, and for other purposes. Includes language authorizing the collection of Monograph Reform user fees. H.J.Res.28 - Further Additional Continuing Appropriations Act, 2019 - This joint resolution provides continuing FY2019 appropriations to several federal agencies through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. H.J.Res.31 - Consolidated Appropriations Act, 2019 -- This joint resolution provides continuing FY2019 appropriations for the Department of Homeland Security (DHS) through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. It is known as a continuing resolution (CR) and ends the partial DHS shutdown that began on December 22, 2018, because the existing CR expired and the FY2019 DHS appropriations bill has not been enacted. H.R.268 - Supplemental Appropriations Act, 2019 -- This bill provides $12.1 billion in FY2019 supplemental appropriations to several federal departments and agencies for expenses related to the consequences of recent wildfires, hurricanes, volcanos, earthquakes, typhoons, and other natural disasters. S.726 - Personal Care Products Safety Act -- To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. Cosmetic Safety Enhancement Act of 2019 (Pallone/Shimkus discussion draft) -- To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic safety, and for other purposes H.R.3443 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 S.1895 - Lower Health Care Costs Act
2019 · second_quarter · Health Issues
H.R. 269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 - Provisions related to reauthorization of the Pandemic and All-Hazards Preparedness Act H.R. 447: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 478: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation H.R. 965: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 985: FAST Generics Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1093: Stop Price Gouging Act - Provisions related to prescription drug pricing H.R. 1332: Fair Care Act of 2019 - Provisions related to prescription drug pricing, patent issues, Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 1409: Transparency in All Health Care Pricing Act of 2019 - Provisions related to prescription drug pricing transparency H.R. 1478: Affordable Insulin Act of 2019 - Provisions related to importation H.R. 1506: Fair and Immediate Release of (FAIR) Generic Drugs Act - Provisions related to generic prescription drug approvals H.R. 1603: Alan Reinstein Ban Asbestos Now Act of 2019 - Provisions related to use of asbestos in manufacturing H.R. 1730: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing H.R. 2011: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products H.R. 2020: STEER Act - Provisions related to encapsulating & tableting machine registration H.R. 2038: State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 - Provisions related to prescription drug pricing H.R. 2064: To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes - Provisions related to prescription drug samples H.R. 2069: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs H.R. 2087: Drug Price Transparency Act - Provisions related to prescription drug pricing and transparency H.R. 2113: Prescription Drug STAR Act - Provisions related to prescription drug pricing, reporting and product samples H.R. 2115: Public Disclosure of Drug Discounts Act - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2296: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency H.R. 2376: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 2569: Comprehensive Addiction Resources Emergency Act of 2019 - Provisions related to opioid crisis response funding H.R. 2584: To amend the Congressional Budget Act of 1974 respecting the scoring of preventive health savings - Provisions related to CBO scoring of preventive health savings H.R. 2734: Safer Prescribing of Controlled Substances Act - Provisions related to the prescribing of prescription drugs H.R. 2917: Opioid Crisis Accountability Act of 2019 - Provisions related to prescription drug marketing H.R. 3223: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers H.R. 3327: To amend title XI of the Social Security Act to require that direct-to-consumer television advertisements for prescription drugs and biological products include the list price of such drugs and products, and for other purposes - Provisions related to direct-to-consumer prescription drug advertising H.R. 3379: Price Relief, Innovation, and Competition for Essential Drugs or PRICED Act - Provisions related to exclusivity H.R. 3408: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3415: To amend title XVIII of the Social Security Act to require prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the Medicare program - Provisions related to drug pricing transparency H.R. 3443: To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes - Provisions related to FDA over-the-counter drug approvals S. 61: Safe and Affordable Drugs from Canada Act of 2019 - Provisions related to importation S. 73: End Taxpayer Subsidies for Drug Ads Act - Provisions related to direct-to-consumer prescription drug advertising S. 97: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 340: Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act of 2019 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 378: Stop Price Gouging Act - Provisions related to prescription drug pricing S. 419: Protecting Americans from Dangerous Opioids Act - Provisions related to FDA drug approvals S. 440: PACED Act - Provisions related to use of sovereign immunity in patent disputes S. 474: Stopping the Pharmaceutical Industry from Keeping Drug Expensive (SPIKE) Act of 2019 - Provisions related to increases in the wholesale acquisition costs of prescription drugs S. 637: Combatting Unreasonable Rises and Excessively (CURE) High Drug Prices Act - Provisions related to prescription drug pricing and transparency S. 657: Drug Price Transparency Act - Provisions related to prescription drug pricing transparency and commercial market rebates S. 658: Accelerated Drug Approval for Prescription Therapies Act - Provisions related to FDA drug approvals S. 660: Efficiency and Transparency in Petitions Act - Provisions related to the FDA citizen petition process S. 741: Cancer Drug Parity Act of 2019 - Provisions related to prescription drug patient cost-sharing S. 977: Transparent Drug Pricing Act of 2019 - Provisions related to pharmaceutical drug pricing S. 989: STEER Act - Provisions related to encapsulating & tableting machine registration S. 1140: Protecting Access to Biosimilars Act of 2019 - Provisions related to biological products S. 1227: Prescription Pricing for the People Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1384: Prescription Drug Rebate Reform Act of 2019 - Provisions related to prescription drug pricing and commercial rebates S. 1391: FAIR Drug Pricing Act of 2019 - Provisions related to prescription drug pricing and transparency S. 1437: Drug-price Transparency in Communications (DTC) Act - Provisions related to direct-to-consumer prescription drug advertising S. 1532: Pharmacy Benefit Manager Accountability Study Act of 2019 - Provisions related to prescription drug pricing transparency and pharmacy benefit managers S. 1664: Prescription Drug Price Reporting Act - Provisions related to prescription drug pricing transparency Transparency policy issues Drug cost and pricing policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues High deductible health plans/HSA policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues FDA modernization policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Cancer drug vial size policy issues TRICARE pharmacy pilot program Drug shortages policy issues Reauthorization of the Pandemic and All-Hazards Preparedness Act Request for Information: HHS Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs (RIN 0991-ZA49)
2019 · second_quarter · Health Issues
Support the Protecting Pre-Existing Conditions and Making Health Care More Affordable Act of 2019. Support H.R. 986, the Protecting Americans with Pre-Existing Conditions Act of 2019. Support H.R. 987, the Strengthening Health Care and Prescription Drug Costs Act. Support H.R. 2862 the Vaccine Awareness Campaign to Champion Immunization Nationally and Enhance Safety (VACCINES) Act of 2019. Support S. 1944/H.R. 3447, the Public Health Funding Restoration Act. Support efforts to maintain and strengthen the Affordable Care Act. Support passage of H.R. 269, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act. Expressed concerns with provisions in S. 696/H.R.1597, the National Nurse Act of 2019. Support the Comprehensive TB Elimination Act. Support H.R. 2507, the Newborn Screening Saves Lives Reauthorization Act of 2019. Support H.R. 3443, the bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act. Support Community Access, Resources, and Education for Families (CARE for Families) Act. Support H.R. 2822, the Family-to-Family Reauthorization Act of 2019. Support S. 916/H.R. 1897, the Mothers and Offspring Mortality and Morbidity Awareness (MOMMA) Act. Support H.R. 1329: the Medicaid Reentry Act. Support H.R. 3080, the Comprehensive TB Elimination Act of 2019.
Client expense: $23,650 · Firm income: Not reported
2019 · second_quarter · Pharmacy
General issues related to over the counter pharmaceuticals. Issues related to draft legislation addressing the over the counter drug monograph process including H.R.269, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 and H. R. 3443, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · second_quarter · Health Issues
Issues related to the over the counter drug monograph process including H.R.269, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 and H. R. 3443, the Over-the-counter Monograph Safety, Innovation, and Reform Act of 2019. Issues related to sunscreen.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · second_quarter · Health Issues
H.R. 2482 - The Mainstreaming Addition Treatment Act of 2019 - Support for policies increasing the ability to access MAT to treat addiction. H.R. 3443 - The OTC Monograph Safety Innovation and Reform Act of 2019 - Support for policies that enable OTC monograph reform. Regulations promulgated by ONC and HHS related to patient matching, interoperability, unique patient identifiers, unique device identifiers and other HIT tools that can support better patient safety in our healthcare system. Issues related to creating a listing mechanism for dietary supplements. Issues related to the implementation on the SUPPORT Act (P.L. 115-271) Issues related to curbing antibiotic resistance.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · second_quarter · Pharmacy
H.R. 2482 - The Mainstreaming Addition Treatment Act of 2019 - Support for policies increasing the ability to access MAT to treat addiction. H.R. 3443 - The OTC Monograph Safety Innovation and Reform Act of 2019 - Support for policies that enable OTC monograph reform. Issues related to the implementation on the SUPPORT Act (P.L. 115-271) regarding MAT treatment. Issues related to curbing antibiotic resistance.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · second_quarter · Medical/Disease Research/Clinical Labs
Over the counter drug approval process for sunscreen ingredients; Implementation of Public Law 113-195, the Sunscreen Innovation Act; House and Senate FY 2020 Ag-FDA Appropriations bills and reports (H.R. 3164); Sunscreen use in schools; Sunscreen provisions in H.R. 3443, Over-the-Counter Monograph Safety, Innovation and Reform Act of 2019; Issues related to state bans on sunscreen ingredients.
Client expense: Not reported · Firm income: $70,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
| HR 19 |
116th |
| Related bill |
Client expense: $128,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE, Treasury, Dept of, Vice President of the U.S.
Client expense: $165,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), SENATE, Treasury, Dept of
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $177,500 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of
Client expense: $1,360,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $6,230,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), President of the U.S., SENATE, U.S. Trade Representative (USTR)
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Client expense: $166,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of
Client expense: $6,310,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $870,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $173,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of
Client expense: $6,220,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Government targets: Agriculture, Dept of (USDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE