Expanding Access to Affordable Prescription Drugs and Medical Devices Act
Legislative Progress
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Expanding Access to Affordable Prescription Drugs and Medical Devices Act This bill requires the Department of Health and Human Services (HHS) to provide assistance to certain nonprofit manufacturers of drugs or medical devices, establishes requirements in statute for a manufacturer to qualify as a tax-exempt nonprofit organization, and addresses related issues. Generally, to be a tax-exempt nonprofit drug (or biological product) or device manufacturer under this bill, an organization must (1) only manufacture drugs or devices that further a public health objective, such as addressing barriers related to availability or price; (2) sell each drug or device at a public list price that is not above a certain amount as determined by various costs; (3) not compensate any employee an amount more than 40 times the compensation of the lowest-compensated employee or applicable contractor; and (4) meet various existing requirements for being a tax-exempt organization. HHS must provide assistance to tax-exempt nonprofit organizations that meet certain requirements by awarding cooperative agreements, providing low-interest revolving loans, and waiving certain user fees. For awarding such cooperative agreements and loans, HHS shall prioritize organizations expecting to market an eligible drug or device (1) at a price lower than existing treatments, or (2) that HHS has identified as a public health priority. The Food and Drug Administration may prioritize the review of an application for market approval of a qualifying drug or medical device from a tax-exempt nonprofit organization if the organization commits to a specific price that is significantly lower than similar treatments on the market.
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
HR 432 and S 828 To provide for the coverage of marriage and family therapist services and mental health counselor services under Medicare. HR 708 and S 168 To provide temporary licensing reciprocity for telehealth and interstate health care treatment. HR 1384 and S 445 Loosens restrictions on doctors prescribing buprenorphine for addiction treatment. HR 2503 To direct the HHS Secretary to establish an interagency council on social determinants of health. S 660 Improves access to tele-mental health during the length of the COVID-19 PHE. S 674 To support public health infrastructure (funding up to $4.5 billion). HR 2255/S. 1024 To recapture unused immigrant visas and allocate them to doctors and nurses to help in the fight against COVID-19. HR 2903/S. 1512 Comprehensive bill to expand telehealth access and make permanent telehealth flexibilities available during COVID-19 pandemic. HR 3203/S. 773 To enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program. S. 1162 To expand access to Programs of All-Inclusive Care for the Elderly (PACE). HR 4118 To authorize the HHS Secretary to invest in community-based violence reduction initiatives. S. 2257 To reduce drug and device shortages and costs. HR 5801 To apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans. Health care workforce shortage concerns. S. 3626 To improve access to the Program of All-Inclusive Care for the Elderly (PACE) HR 7236 To expand the availability of mental, emotional, and behavioral health services under the Medicaid program HR 7353 To treat telehealth services as excepted benefits HR 7961 To protect hospital personnel from violence S 4352 To require a study on the effects of travel nurse agencies on the health industry during the COVID-19 pandemic S 3189 To provide a pathway to health careers through health profession opportunity grants HR 7666 Reauthorizes, expands, and modifies programs, grants, and activities that focus on mental and behavioral health
Read twice and referred to the Committee on Finance.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
Client expense: $200,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · fourth_quarter · Health Issues
Support for non-profit pharmaceutical manufacturers, S. 2257
Client expense: Not reported · Firm income: $7,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · third_quarter · Health Issues
HR 432 and S 828 To provide for the coverage of marriage and family therapist services and mental health counselor services under Medicare. HR 708 and S 168 To provide temporary licensing reciprocity for telehealth and interstate health care treatment. HR 1384 and S 445 Loosens restrictions on doctors prescribing buprenorphine for addiction treatment. HR 2503 To direct the HHS Secretary to establish an interagency council on social determinants of health. S 660 Improves access to tele-mental health during the length of the COVID-19 PHE. S 674 To support public health infrastructure (funding up to $4.5 billion). HR 2255/S. 1024 To recapture unused immigrant visas and allocate them to doctors and nurses to help in the fight against COVID-19. HR 2903/S. 1512 Comprehensive bill to expand telehealth access and make permanent telehealth flexibilities available during COVID-19 pandemic. HR 3203/S. 773 To enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program. S. 1162 To expand access to Programs of All-Inclusive Care for the Elderly (PACE). HR 4118 To authorize the HHS Secretary to invest in community-based violence reduction initiatives. S. 2257 To reduce drug and device shortages and costs. HR 5801 To apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans. Health care workforce shortage concerns. S. 3626 To improve access to the Program of All-Inclusive Care for the Elderly (PACE) HR 7236 To expand the availability of mental, emotional, and behavioral health services under the Medicaid program HR 7353 To treat telehealth services as excepted benefits HR 7961 To protect hospital personnel from violence S 4352 To require a study on the effects of travel nurse agencies on the health industry during the COVID-19 pandemic S 3189 To provide a pathway to health careers through health profession opportunity grants HR 7666 Reauthorizes, expands, and modifies programs, grants, and activities that focus on mental and behavioral health
Client expense: $200,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · third_quarter · Health Issues
Support for non-profit pharmaceutical manufacturers, S. 2257
Client expense: Not reported · Firm income: $7,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
Support for non-profit pharmaceutical manufacturers, S. 2257
Client expense: Not reported · Firm income: $9,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2022 · second_quarter · Health Issues
HR 432 and S 828 To provide for the coverage of marriage and family therapist services and mental health counselor services under Medicare. HR 708 and S 168 To provide temporary licensing reciprocity for telehealth and interstate health care treatment. HR 1384 and S 445 Loosens restrictions on doctors prescribing buprenorphine for addiction treatment. HR 2503 To direct the HHS Secretary to establish an interagency council on social determinants of health. S 660 Improves access to tele-mental health during the length of the COVID-19 PHE. S 674 To support public health infrastructure (funding up to $4.5 billion). HR 2255/S. 1024 To recapture unused immigrant visas and allocate them to doctors and nurses to help in the fight against COVID-19. HR 2903/S. 1512 Comprehensive bill to expand telehealth access and make permanent telehealth flexibilities available during COVID-19 pandemic. HR 3203/S. 773 To enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program. S. 1162 To expand access to Programs of All-Inclusive Care for the Elderly (PACE). HR 4118 To authorize the HHS Secretary to invest in community-based violence reduction initiatives. S. 2257 To reduce drug and device shortages and costs. HR 5801 To apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans. Health care workforce shortage concerns. S. 3626 To improve access to the Program of All-Inclusive Care for the Elderly (PACE) HR 7236 To expand the availability of mental, emotional, and behavioral health services under the Medicaid program HR 7353 To treat telehealth services as excepted benefits HR 7961 To protect hospital personnel from violence S 4352 To require a study on the effects of travel nurse agencies on the health industry during the COVID-19 pandemic S 3189 To provide a pathway to health careers through health profession opportunity grants
Client expense: $200,000 · Firm income: Not reported
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2022 · first_quarter · Health Issues
HR 432 and S 828 To provide for the coverage of marriage and family therapist services and mental health counselor services under Medicare. HR 708 and S 168 To provide temporary licensing reciprocity for telehealth and interstate health care treatment. HR 1384 and S 445 Loosens restrictions on doctors prescribing buprenorphine for addiction treatment. HR 2503 To direct the HHS Secretary to establish an interagency council on social determinants of health. S 660 Improves access to tele-mental health during the length of the COVID-19 PHE. S 674 To support public health infrastructure (funding up to $4.5 billion). HR 2255/S. 1024 To recapture unused immigrant visas and allocate them to doctors and nurses to help in the fight against COVID-19. HR 2903/S. 1512 Comprehensive bill to expand telehealth access and make permanent telehealth flexibilities available during COVID-19 pandemic. HR 3203/S. 773 To enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program. S. 1162 To expand access to Programs of All-Inclusive Care for the Elderly (PACE). HR 4118 To authorize the HHS Secretary to invest in community-based violence reduction initiatives. S. 2257 To reduce drug and device shortages and costs. HR 5801 To apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans. Health care workforce shortage concerns. S. 3626 To improve access to the Program of All-Inclusive Care for the Elderly (PACE)
Client expense: $200,000 · Firm income: Not reported
2022 · first_quarter · Health Issues
Support for non-profit pharmaceutical manufacturers, S. 2257
Client expense: Not reported · Firm income: $5,250
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · fourth_quarter · Pharmacy
H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act - Rep. Pallone, Frank, Jr. [D-NJ-6] - drug pricing H.R. 153 - Protecting Consumer Access to Generic Drugs Act of 2021 - Rep. Rush, Bobby L. [D-IL-1] - generic drugs H.R. 1829 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Rep. Harshbarger, Diana [R-TN-1] - PBMs H.R. 1873 - Advancing Education on Biosimilars Act of 2021 - Rep. Bucshon, Larry [R-IN-8] - drug education H.R. 2071 - Medicare Prescription Drug Price Negotiation Act of 2021 - Rep. Welch, Peter [D-VT-At Large] - Part D price negotiation H.R. 2139 - Medicare Drug Price Negotiation Act - Rep. Doggett, Lloyd [D-TX-35] - Part D price negotiation H.R. 2148 - Prescription Drug Price Relief Act of 2021 - Rep. Khanna, Ro [D-CA-17] - excessive drug pricing H.R. 2608 - Ensuring Seniors Access to Local Pharmacies Act of 2021 - Rep. Welch, Peter [D-VT-At Large] - rural health H.R. 2829 - End Price Gouging for Medications Act - Rep. Welch, Peter [D-VT-At Large] - reference prices H.R. 2846 - Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021 - Rep. McKinley, David B. [R-WV-1] - biosimilar drugs H.R. 2855 - Star Rating for Biosimilars Act - Rep. Tonko, Paul [D-NY-20] - biosimilar drugs H.R. 2891 - Preserve Access to Affordable Generics and Biosimilars Act - Rep. Nadler, Jerrold [D-NY-10] - biosimilar drugs H.R. 3831 - Seniors Securing Access to Vital and Essential Prescription Drugs Act - Rep. Lee, Susie [D-NV-3] - Part D H.R. 4121 - PRO Seniors Act - Rep. Arrington, Jodey C. [R-TX-19] - drug rebates H.R. 4417 - Capping Drug Costs for Seniors Act of 2021 - Rep. Horsford, Steven [D-NV-4] - reduces out of pocket spending H.R. 4418 - SPIKE Act - Rep. Horsford, Steven [D-NV-4] - Medicare drug price threshold H.R. 5623 - The Insulin Cost Reduction Act - Rep. Grothman, Glenn [R-WI-6] - insulin prices under part D H.R. 6000 - Cures 2.0 Act - Rep. DeGette, Diana [D-CO-1] - drug development H.R. 6228 - To limit cost sharing for prescription drugs - Rep. Manning, Kathy E. [D-NC-6] - cost sharing S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Sen. Blackburn, Marsha [R-TN] - PBMs S. 833 - Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Sen. Klobuchar, Amy [D-MN] - Part D price negotiation S. 898 - Fair Accountability and Innovative Research Drug Pricing Act of 2021 - Sen. Baldwin, Tammy [D-WI] - reporting price increases S. 908 - Medicare Drug Price Negotiation Act - Sen. Sanders, Bernard [I-VT] - Part D price negotiation S. 1123 - PING Act - Sen. Blackburn, Marsha [R-TN] - Part D non-interference S. 1323 - End Price Gouging for Medications Act - Sen. Merkley, Jeff [D-OR] - reference prices S. 1428 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy [D-MN] - biosimilar drugs S. 2257 - Expanding Access to Affordable Prescription Drugs and Medical Devices Act - Sen. Rosen, Jacky [D-NV] - drug shortages and costs S. 2304 - DTC Act of 2021- Sen. Durbin, Richard J. [D-IL] - drug pricing S. 2327 - Seniors Prescription Drug Relief Act - Sen. Cassidy, Bill [R-LA] - Medicare part D modernization redesign and reduces out of pocket spending S. 2815 - Seniors Saving on Insulin Act - Sen. Kennedy, John [R-LA] - Part D Senior Savings model S. 3339 - A bill to limit cost sharing for prescription drugs - Sen. Warnock, Raphael G. [D-GA] - cost sharing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
2021 · fourth_quarter · Health Issues
HR 432 and S 828 To provide for the coverage of marriage and family therapist services and mental health counselor services under Medicare. HR 708 and S 168 To provide temporary licensing reciprocity for telehealth and interstate health care treatment. HR 1384 and S 445 Loosens restrictions on doctors prescribing buprenorphine for addiction treatment. HR 2503 To direct the HHS Secretary to establish an interagency council on social determinants of health. S 660 Improves access to tele-mental health during the length of the COVID-19 PHE. S 674 To support public health infrastructure (funding up to $4.5 billion). HR 2255/S. 1024 To recapture unused immigrant visas and allocate them to doctors and nurses to help in the fight against COVID-19. HR 2903/S. 1512 Comprehensive bill to expand telehealth access and make permanent telehealth flexibilities available during COVID-19 pandemic. HR 3203/S. 773 To enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program. S. 1162 To expand access to Programs of All-Inclusive Care for the Elderly (PACE). HR 4118 To authorize the HHS Secretary to invest in community-based violence reduction initiatives. S. 2257 To reduce drug and device shortages and costs. HR 5801 To apply additional payments, discounts, and other financial assistance towards the cost-sharing requirements of health insurance plans. Health care workforce shortage concerns.
Client expense: $200,000 · Firm income: Not reported
2021 · fourth_quarter · Health Issues
Support for non-profit pharmaceutical manufacturers, S. 2257
Client expense: Not reported · Firm income: $5,250
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · third_quarter · Pharmacy
H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act - Rep. Pallone, Frank, Jr. [D-NJ-6] - drug pricing H.R. 153 - Protecting Consumer Access to Generic Drugs Act of 2021 - Rep. Rush, Bobby L. [D-IL-1] - generic drugs H.R. 1829 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Rep. Harshbarger, Diana [R-TN-1] - PBMs H.R. 1873 - Advancing Education on Biosimilars Act of 2021 - Rep. Bucshon, Larry [R-IN-8] - drug education H.R. 2071 - Medicare Prescription Drug Price Negotiation Act of 2021 - Rep. Welch, Peter [D-VT-At Large] - Part D price negotiation H.R. 2139 - Medicare Drug Price Negotiation Act - Rep. Doggett, Lloyd [D-TX-35] - Part D price negotiation H.R. 2148 - Prescription Drug Price Relief Act of 2021 - Rep. Khanna, Ro [D-CA-17] - excessive drug pricing H.R. 2608 - Ensuring Seniors Access to Local Pharmacies Act of 2021 - Rep. Welch, Peter [D-VT-At Large] - rural health H.R. 2829 - End Price Gouging for Medications Act - Rep. Welch, Peter [D-VT-At Large] - reference prices H.R. 2846 - Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021 - Rep. McKinley, David B. [R-WV-1] - biosimilar drugs H.R. 2855 - Star Rating for Biosimilars Act - Rep. Tonko, Paul [D-NY-20] - biosimilar drugs H.R. 2891 - Preserve Access to Affordable Generics and Biosimilars Act - Rep. Nadler, Jerrold [D-NY-10] - biosimilar drugs H.R. 3831 - Seniors Securing Access to Vital and Essential Prescription Drugs Act - Rep. Lee, Susie [D-NV-3] - Part D H.R. 4121 - PRO Seniors Act - Rep. Arrington, Jodey C. [R-TX-19] - drug rebates H.R. 4417 - Capping Drug Costs for Seniors Act of 2021 - Rep. Horsford, Steven [D-NV-4] - reduces out of pocket spending H.R. 4418 - SPIKE Act - Rep. Horsford, Steven [D-NV-4] - Medicare drug price threshold S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Sen. Blackburn, Marsha [R-TN] - PBMs S. 833 - Empowering Medicare Seniors to Negotiate Drug Prices Act of 2021 - Sen. Klobuchar, Amy [D-MN] - Part D price negotiation S. 898 - Fair Accountability and Innovative Research Drug Pricing Act of 2021 - Sen. Baldwin, Tammy [D-WI] - reporting price increases S. 908 - Medicare Drug Price Negotiation Act - Sen. Sanders, Bernard [I-VT] - Part D price negotiation S. 1123 - PING Act - Sen. Blackburn, Marsha [R-TN] - Part D non-interference S. 1323 - End Price Gouging for Medications Act - Sen. Merkley, Jeff [D-OR] - reference prices S. 1428 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy [D-MN] - biosimilar drugs S. 2257 - Expanding Access to Affordable Prescription Drugs and Medical Devices Act - Sen. Rosen, Jacky [D-NV] - drug shortages and costs S. 2304 - DTC Act of 2021- Sen. Durbin, Richard J. [D-IL] - drug pricing S. 2327 - Seniors Prescription Drug Relief Act - Sen. Cassidy, Bill [R-LA] - Medicare part D modernization redesign and reduces out of pocket spending S. 2815 - Seniors Saving on Insulin Act - Sen. Kennedy, John [R-LA] - Part D Senior Savings model Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
2021 · third_quarter · Health Issues
National Cancer Research Month (S Res 253) Health disparities Access to clinical trials for underrepresented populations Improving Social Determinants of Health Act (S.104/H.R.379) Comprehensive Breast Reconstruction Act of 2021 (H.R. 469) Expanding Access to Affordable Prescription Drugs and Medical Devices Act (S.2257) CURES 2.0 draft legislation Policies related to cancer survivorship Policies related to development of the Advanced Research Projects Agency for Health Policies related to medications access in during emergencies Polices related to PBM and drug cost transparency Policies related to COVID-19 vaccination distribution Policies impacting immunocompromised people Policies related to development of a public option Guidance related to use of patient reported outcomes in clinical trials Request to become Health People 2030 Champion Responding to Social Determinants of Health Caucus Request for Information OMB RFI on Methods and Leading Practices for Advancing Equity and Support for Underserved Communities through Government
Client expense: Not reported · Firm income: $42,000
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Natl Institutes of Health (NIH), Office of Management & Budget (OMB), SENATE
2021 · third_quarter · Health Issues
HR 432 and S 828 To provide for the coverage of marriage and family therapist services and mental health counselor services under Medicare. HR 708 and S 168 To provide temporary licensing reciprocity for telehealth and interstate health care treatment. HR 1384 and S 445 Loosens restrictions on doctors prescribing buprenorphine for addiction treatment. HR 2503 To direct the HHS Secretary to establish an interagency council on social determinants of health. S 660 Improves access to tele-mental health during the length of the COVID-19 PHE. S 674 To support public health infrastructure (funding up to $4.5 billion). HR 2255/S. 1024 To recapture unused immigrant visas and allocate them to doctors and nurses to help in the fight against COVID-19. HR 2903/S. 1512 Comprehensive bill to expand telehealth access and make permanent telehealth flexibilities available during COVID-19 pandemic. HR 3203/S. 773 To enable certain hospitals that were participating in or applied for the drug discount program under section 340B of the Public Health Service Act prior to the COVID-19 public health emergency to temporarily maintain eligibility for such program. S. 1162 To expand access to Programs of All-Inclusive Care for the Elderly (PACE). HR 4118 To authorize the HHS Secretary to invest in community-based violence reduction initiatives. S. 2257 To reduce drug and device shortages and costs. Workforce shortage concerns.
Client expense: $200,000 · Firm income: Not reported
2021 · third_quarter · Health Issues
Support for non-profit pharmaceutical manufacturers, S. 2257
Client expense: Not reported · Firm income: $11,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · second_quarter · Pharmacy
H.R. 3 - Elijah E. Cummings Lower Drug Costs Now Act - Rep. Pallone, Frank, Jr. [D-NJ-6] - drug pricing H.R. 153 - Protecting Consumer Access to Generic Drugs Act of 2021 - Rep. Rush, Bobby L. [D-IL-1] - generic drugs H.R. 1829 - To require the Government Accountability Office to study the role pharmaceutical benefit managers play in the pharmaceutical supply chain and provide Congress with appropriate policy recommendations, and for other purposes - Rep. Harshbarger, Diana [R-TN-1] - PBMs H.R. 1873 - To educate health care providers and the public on biosimilar biological products, and for other purposes - Rep. Bucshon, Larry [R-IN-8] - drug education H.R. 2071 - To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries - Rep. Welch, Peter [D-VT-At Large] - Part D price negotiation H.R. 2139 - Medicare Drug Price Negotiation Act - Rep. Doggett, Lloyd [D-TX-35] - Part D price negotiation H.R. 2148 - Prescription Drug Price Relief Act of 2021 - Rep. Khanna, Ro [D-CA-17] - excessive drug pricing H.R. 2608 - Ensuring Seniors Access to Local Pharmacies Act of 2021 - Rep. Welch, Peter [D-VT-At Large] - rural health H.R. 2829 - To require the Secretary of Health and Human Services to establish reference prices for prescription drugs for purposes of Federal health programs - Rep. Welch, Peter [D-VT-At Large] - reference prices H.R. 2846 - Ensuring Access to Lower-Cost Medicines for Seniors Act of 2021 - Rep. McKinley, David B. [R-WV-1] - biosimilar drugs H.R. 2855 - Star Rating for Biosimilars Act - Rep. Tonko, Paul [D-NY-20] - biosimilar drugs H.R. 2891 - Preserve Access to Affordable Generics and Biosimilars Act - Rep. Nadler, Jerrold [D-NY-10] - biosimilar drugs H.R. 3831 - Seniors Securing Access to Vital and Essential Prescription Drugs Act - Rep. Lee, Susie [D-NV-3] - Part D H.R. 4121 - To codify a final rule issued by the Secretary of Health and Human Services relating to fraud and abuse and the removal of safe harbor protection for certain drug rebates - Rep. Arrington, Jodey C. [R-TX-19] - drug rebates S. 298 - Pharmacy Benefit Manager Accountability Study Act of 2021 - Sen. Blackburn, Marsha [R-TN] - PBMs S. 833 - A bill to amend XVIII of the Social Security Act to allow the Secretary of Health and Human Services to negotiate fair prescription drug prices under part D of the Medicare program - Sen. Klobuchar, Amy [D-MN] - Part D price negotiation S. 898 - Fair Accountability and Innovative Research Drug Pricing Act of 2021 - Sen. Baldwin, Tammy [D-WI] - reporting price increases S. 908 - Medicare Drug Price Negotiation Act - Sen. Sanders, Bernard [I-VT] - Part D price negotiation S. 1123 - PING Act - Sen. Blackburn, Marsha [R-TN] - Part D non-interference S. 1132 - A bill to establish a cap on out-of-pocket costs for insulin - Sen. Kennedy, John [R-LA] - out-of-pocket costs S. 1323 - A bill to require the Secretary of Health and Human Services to establish reference prices for prescription drugs for purposes of Federal health programs - Sen. Merkley, Jeff [D-OR] - reference prices S. 1428 - Preserve Access to Affordable Generics and Biosimilars Act - Sen. Klobuchar, Amy [D-MN] - biosimilar drugs S. 2257 - A bill to provide Federal support for nonprofit generic and essential medicine and device manufacturers to increase the availability of drugs and devices in order to reduce drug or device shortages and drug and device costs - Sen. Rosen, Jacky [D-NV] - drug shortages and costs S. 2304 - A bill to amend title XI of the Social Security Act to require that direct-to-consumer advertisements for prescription drugs and biological products include an appropriate disclosure of pricing information - Sen. Durbin, Richard J. [D-IL] - drug pricing Regulatory Issues: Issues relating to long term safety and effectiveness of medical devices and drugs, including registries; issues relating to post-market surveillance of drugs and medical devices; issues relating to price of drugs and biologics and proposals to limit high prices; issues related to prescription drug coupons and discount programs; issues relating to vaccines; issues related to health equity; issues related to vaccination; potential Medicare NCD relating to monoclonal antibodies for treatment of Alzheimers disease; Executive Orders relating to international pricing, Part D rebates, insulin costs, and importation; issues related to drug patents and market exclusivity; issues related to pharmacy benefit managers; issues related to biosimilars; issues related to approval of drugs and biologics; issues relating to opioids; issues relating to COVID-19, including vaccines and therapeutics; issues related to health care price transparency; issues relating to prescription drug rebates; direct-to-consumer advertising for prescription drugs; issues related to proposed changes to removal of safe harbor protection for rebates (proposed rule); issues relating to access for investigational drugs; and other issues relating to health care reform implementation.
2021 · second_quarter · Health Issues
Support for non-profit pharmaceutical manufacturers, S. 2257
Client expense: Not reported · Firm income: $9,600
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
Client expense: $2,630,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), SENATE
Client expense: $2,250,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, Treasury, Dept of, White House Office
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), SENATE
Client expense: $2,510,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Management & Budget (OMB), Office of Personnel Management (OPM), SENATE, Treasury, Dept of, White House Office