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Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
96pct
350d open
vs 9,062 other HR bills in the 116th — cohort avg 39d
Safeguarding Therapeutics Act This bill authorizes the Food and Drug Administration to destroy imported counterfeit medical devices.
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 (11)
Became Public Law No: 116-304.
Became Public Law No: 116-304.
Signed by President.
Signed by President.
Presented to President.
Presented to President.
Motion to reconsider laid on the table Agreed to without objection.
On motion that the House agree to the Senate amendment Agreed to without objection. (text: CR H7131)
Resolving differences -- House actions: On motion that the House agree to the Senate amendment Agreed to without objection.(text: CR H7131)
Mrs. Dingell asked unanimous consent to take the bill, H.R. 5663 from the Speaker's Table and agree to the Senate amendment. (consideration: CR H7131)
Mrs. Dingell asked unanimous consent that the House agree to the Senate amendment.
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2021 · fourth_quarter · Health Issues
Issues related to the sterilization of medical devices. Issues related to digital health, data interoperability, and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. H.R. 5663, Safeguarding Therapeutics Act. Issues related to telemedicine and remote patient monitoring, including H.R.4670 - Advanced Safe Testing at Residence Telehealth Act of 2021. Issues related to global medical supply chains. Issues related to H.R. 6000, Cures 2.0 Act. Issues related to servicing of medical devices. Issues related to ONC and CMS implementation of effective and efficient interoperability standards. Issues related to opioid-induced respiratory compromise continuous patient monitoring, including H.R. 5932 - Inpatient Opioid Safety Act of 2021. Issues related to disparities of care. Support for the Cardiovascular Advances in Research and Opportunity Legacy (CAROL) Act (H.R. 1193 and S. 1133). Issue related to H.R. 5376, Build Back Better Act. Issues pertaining to FDA, including medical device user fee reauthorization.
Client expense: $800,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Pipeline & Hazardous Materials Safety Administration, SENATE, Transportation, Dept of (DOT), White House Office
2021 · third_quarter · Health Issues
Issues related to the sterilization of medical devices. Issues related to digital health, interoperability, and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. H.R. 5663, Safeguarding Therapeutics Act. Issues related to telemedicine and remote patient monitoring. Issues related to global medical supply chains. Issues related to draft legislation for 21st Century Cures 2.0. S. 4473/H.R. 7956, Critical Medical Infrastructure Right to Repair Act of 2020. Issues related to ONC and CMS implementation of effective and efficient interoperability standards. Issues related to opioid-induced respiratory compromise patient monitoring. Support for the Amputation Reduction and Compassion Act (H.R. 2631 - ARC Act of 2021). Issues related to preventative health screenings. Issues related to disparities of care. Support for the Cardiovascular Advances in Research and Opportunity Lageacy (CAROL) Act (H.R. 1193 and S. 1133). Issues related to The Build Back Better Act, A bill to provide for Reconciliation pursuant to title II of the concurrent Resolution on the Budget for Fiscal Year 2022 S. Con Res. 14.
Client expense: $2,267,000 · Firm income: Not reported
2021 · second_quarter · Health Issues
Issues related to value-based healthcare and modernization of fraud and abuse laws. Issues related to the sterilization of medical devices. Issues related to digital health, interoperability, and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. H.R. 5663, Safeguarding Therapeutics Act. Issues related to telemedicine and remote patient monitoring. Issues related to global medical supply chains. Issues related to draft legislation for 21st Century Cures 2.0. S. 4473/H.R. 7956, Critical Medical Infrastructure Right to Repair Act of 2020. Issues related to ONC and CMS implementation of effective and efficient interoperability standards. Issues related to opioid induced respiratory compromise patient monitoring. Support for the Amputation Reduction and Compassion Act (H.R. 2631 - ARC Act of 2021). Issues related to preventative health screenings. Issues related to disparities of care. Support for the Cardiovascular Advances in Research and Opportunity Lageacy (CAROL) Act (H.R. 1193 and S. 1133).
Client expense: $1,096,000 · Firm income: Not reported
2021 · first_quarter · Health Issues
Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; Implementation of H.R.748, CARES Act (P.L.116-136); H.R.5663/S.4225, Safeguarding Therapeutics Act (P.L.116-304); H.R.1319, American Rescue Plan Act of 2021 (P.L.117-2).
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2021 · first_quarter · Health Issues
Issues related to value-based healthcare and modernization of fraud and abuse laws. Issues related to the sterilization of medical devices. Issues related to digital health, interoperability, and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. H.R. 5663, Safeguarding Therapeutics Act. Issues related to telemedicine and remote patient monitoring. Issues related to global medical supply chains. Issues related to draft legislation for 21st Century Cures 2.0. S. 4473/H.R. 7956, Critical Medical Infrastructure Right to Repair Act of 2020. Issues related to ONC and CMS implementation of effective and efficient interoperability standards. Issues related to opioid induced respiratory compromise patient monitoring. Support for the Amputation Reduction and Compassion Act. Issues related to the coverage and payment of preventative screenings. Issues related to disparities of care.
Client expense: $930,000 · Firm income: Not reported
Message on Senate action sent to the House.
Passed Senate with an amendment by Unanimous Consent. (text of amendment in the nature of a substitute: CR S7286)
Passed/agreed to in Senate: Passed Senate with an amendment by Unanimous Consent.
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Senate Committee on Health, Education, Labor, and Pensions discharged by Unanimous Consent.
Measure laid before Senate by unanimous consent. (consideration: CR S7286)
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Motion to reconsider laid on the table Agreed to without objection.
On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote. (text: CR H4635)
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.
DEBATE - The House proceeded with forty minutes of debate on H.R. 5663.
Considered under suspension of the rules. (consideration: CR H4635-4636)
Mrs. Dingell moved to suspend the rules and pass the bill, as amended.
Placed on the Union Calendar, Calendar No. 412.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 116-512.
Congress.gov source codes: 5000, H12200
Ordered to be Reported (Amended) by Voice Vote.
Committee Consideration and Mark-up Session Held.
Subcommittee Consideration and Mark-up Session Held.
Ordered to be Reported by Voice Vote.
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
| House |
| Markup by |
| July 15, 2020 |
| Energy and Commerce Committee | House | Referred to | January 21, 2020 |
| September 21, 2020 |
| Reported in House | September 17, 2020 |
| Introduced in House | January 21, 2020 |
| Enrolled Bill | -- |
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, White House Office
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR), White House Office
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Health Issues
- H.R. 863 - DXM Abuse Prevention Act of 2019, regarding all provisions - S. 726 - Personal Care Products Safety Act, regarding all provisions - Issues related to the regulation of over-the-counter drugs - Issues related to cosmetic regulatory reform - Issues related to cosmetic animal testing - Issues related to biosimilars - Issues related to maternal mortality - Issues related to contact lens safety - Issues related to medical product communications - Issues related to medical product review - Issues related to ingredient safety - Issues related to diversity in clinical trials - Issues related to health care pricing transparency - Issues related to peripheral artery disease - H.R. 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - Issues related to drug importation - S. 2543, "Prescription Drug Pricing Reduction Act of 2019", regarding all provisions - H.R. 19, "Lower Costs, More Cures Act of 2019", regarding all provisions - H.R. 748/ S. 3458, "'Coronavirus Aid, Relief, and. Economic Security Act'', regarding all provisions - H.R. 6074, "Coronavirus Preparedness and Response Supplemental Appropriations Act", regarding all provisions - H.R. 6201, "Families First Coronavirus Response Act", regarding all provisions - H.R. 3975, the Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 5663, the Safeguarding Therapeutics Act, regarding all provisions - Issues related to counterfeit health care goods - S. 3468, Preventing Essential Medical Device Shortages Act of 2020 - Issues related to counterfeit medical devices and combination products and authority to destroy counterfeit medical products - Issues related to reporting medical device shortages - Issues related to pandemic response - S. 2740, "Over the Counter Monograph Safety, Innovation, and Reform Act of 2019", regarding all provisions - H.R. 5279, "Cosmetic Safety Enhancement Act", regarding all provisions - H.R. 4296, "Safe Cosmetics and Personal Care Products Act of 2019", regarding all provisions - Issues related to social determinants of health - H.R. 5076/S. 1872, "Protecting Seniors Through Immunization", regarding all provisions - H.R.6062, "To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes", regarding all provisions. - H.R.6952, "To direct the President to appoint a Medical Supplies Response Coordinator to coordinate the efforts of the Federal Government regarding the supply and distribution of certain supplies and equipment relating to COVID-19", regarding all provisions - S.3942, "Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act", regarding all provisions - S.3945, "Bring Entrepreneurial Advancements To Consumers Here In North America Act", regarding all provisions - S.3780, "HOME Act", regarding all provisions - S.3781, "PART Act", regarding all provisions - Issues related to diversity in clinical trials - Issues related to 340B - S.4613, The Contact Lens Rule Modernization Act, regarding all provisions - H.R.3107, "Improving Seniors Timely Access to Care Act of 2019, regarding all provisions - Executive Order 13948: Lowering Drug Prices by Putting America First - Executive Order 13939: Lowering Prices for Patients by Eliminating Kickbacks to Middlemen - Executive Order 13938: Increasing Drug Importation To Lower Prices for American Patients - Executive Order 13937: Access to Affordable Life-Saving Medications -H.R.133 - Consolidated Appropriations Act, 2021, including legislation regarding average sales price (ASP) reporting requirements for certain hyaluronic acid (HA) products that are classified as devices, but reimbursed as drugs under Medicare Part B
Client expense: $1,450,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2020 · fourth_quarter · Health Issues
Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; Implementation of H.R.6201, Families First Coronavirus Response Act (P.L.116-127); Implementation of H.R.748, CARES Act (P.L.116-136); H.R.6800, The Heroes Act; Implementation of H.R.266, Paycheck Protection Program and Health Care Enhancement Act (P.L.116-139); H.R.8337, Continuing Appropriations Act, 2021 and Other Extensions Act; H.R.5663/S.4225, Safeguarding Therapeutics Act; H.R.133, Making consolidated appropriations for the fiscal year ending September 30, 2021, providing coronavirus emergency response and relief, and for other purposes (P.L.116-260).
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
Issues related to value-based health care and modernization of fraud and abuse laws. Issues related to the sterilization of medical devices. Issues related to digital health, interoperability, and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. S. 3468, Preventing Essential Medical Device Shortages Act. P.L 116-136, Coronavirus Aid, Relief, and Economic Security Act, provisions related to device shortage reporting. H.R. 5663, Safeguarding Therapeutics Act. H.R. 6049, Medical Supply Chain Security Act. Issues related to telemedicine and remote patient monitoring including the H.R. 7885, The RPM Access Act. Issues related to global medical supply chains. Issues related to draft legislation for 21st Century Cures 2.0. S. 4473/H.R. 7956, Critical Medical Infrastructure Right to Repair Act of 2020. Issues related to ONC and CMS implementation of effective and efficient interoperability standards.
Client expense: $771,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2020 · fourth_quarter · Pharmacy
Issues related to prescription drug importation; HR 5663 - the Safeguarding Therapeutics Act
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Copyright/Patent/Trademark
Counterfeiting H.R. 5663, Safeguarding Therapeutics Act
Client expense: $1,350,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Army, Dept of (Corps of Engineers), Bureau of Citizenship & Immigration Services (BCIS), Centers For Disease Control & Prevention (CDC), Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Council on Environmental Quality (CEQ), Defense Information Systems Agency, Defense, Dept of (DOD), Energy, Dept of, Environmental Protection Agency (EPA), Equal Employment Opportunity Commission (EEOC), Export-Import Bank of the United States (EXIM Bank), Federal Emergency Management Agency (FEMA), Federal Trade Commission (FTC), Food & Drug Administration (FDA), General Services Administration (GSA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Homeland Security, Dept of (DHS), Interior, Dept of (DOI), Internal Revenue Service (IRS), Justice, Dept of (DOJ), Labor, Dept of (DOL), Natl Economic Council (NEC), Natl Security Council (NSC), Office of Management & Budget (OMB), Office of the Comptroller of the Currency (OCC), Patent & Trademark Office (PTO), Postal Regulatory Commission, SENATE, Securities & Exchange Commission (SEC), Small Business Administration (SBA), State, Dept of (DOS), Treasury, Dept of, U.S. Customs & Border Protection, U.S. Trade Representative (USTR), White House Office
2020 · third_quarter · Consumer Issues/Safety/Products
HR 5663 - "Safeguarding Therapeutics Act". To amend the Federal Food, Drug, and Cosmetic Act to give authority to the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to destroy counterfeit devices.
Client expense: $34,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
H.R.6102: VALID Act of 2020. H.R.5663: Safeguarding Therapeutics Act. Education related to COVID-19 testing.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES
2020 · third_quarter · Health Issues
Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; Implementation of H.R.6201, Families First Coronavirus Response Act (P.L.116-127); Implementation of H.R.748, CARES Act (P.L.116-136); H.R.6800, The Heroes Act; Implementation of H.R.266, Paycheck Protection Program and Health Care Enhancement Act (P.L.116-139); H.R.8337, Continuing Appropriations Act, 2021 and Other Extensions Act; H.R.5663/S.4225, Safeguarding Therapeutics Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
Issues related to value-based health care and modernization of fraud and abuse laws. Issues related to the sterilization of medical devices. Issues related to digital health, interoperability, and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. S. 3468, Preventing Essential Medical Device Shortages Act. P.L 116-136, Coronavirus Aid, Relief, and Economic Security Act, provisions related to device shortage reporting. H.R. 5663, Safeguarding Therapeutics Act. H.R. 6049, Medical Supply Chain Security Act. Issues related to telemedicine and remote patient monitoring. Issues related to global medical supply chains. Issues related to draft legislation for 21st Century Cures 2.0. S. 4473/H.R. 7956, Critical Medical Infrastructure Right to Repair Act of 2020. Issues related to ONC and CMS implementation of effective and efficient interoperability standards.
Client expense: $1,867,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, U.S. Trade Representative (USTR)
2020 · third_quarter · Health Issues
- H.R. 863 - DXM Abuse Prevention Act of 2019, regarding all provisions - S. 726 - Personal Care Products Safety Act, regarding all provisions - Issues related to the regulation of over-the-counter drugs - Issues related to cosmetic regulatory reform - Issues related to cosmetic animal testing - Issues related to biosimilars - Issues related to maternal mortality - Issues related to contact lens safety - Issues related to medical product communications - Issues related to medical product review - Issues related to ingredient safety - Issues related to diversity in clinical trials - Issues related to health care pricing transparency - Issues related to peripheral artery disease - H.R. 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - Issues related to drug importation - S. 2543, "Prescription Drug Pricing Reduction Act of 2019", regarding all provisions - H.R. 19, "Lower Costs, More Cures Act of 2019", regarding all provisions - H.R. 748/ S. 3458, "'Coronavirus Aid, Relief, and. Economic Security Act'', regarding all provisions - H.R. 6074, "Coronavirus Preparedness and Response Supplemental Appropriations Act", regarding all provisions - H.R. 6201, "Families First Coronavirus Response Act", regarding all provisions - H.R. 3975, the Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 5663, the Safeguarding Therapeutics Act, regarding all provisions - Issues related to counterfeit health care goods - S. 3468, Preventing Essential Medical Device Shortages Act of 2020 - Issues related to counterfeit medical devices and combination products and authority to destroy counterfeit medical products - Issues related to reporting medical device shortages - Issues related to pandemic response - S. 2740, "Over the Counter Monograph Safety, Innovation, and Reform Act of 2019", regarding all provisions - H.R. 5279, "Cosmetic Safety Enhancement Act", regarding all provisions - H.R. 4296, "Safe Cosmetics and Personal Care Products Act of 2019", regarding all provisions - Issues related to social determinants of health - H.R. 5076/S. 1872, "Protecting Seniors Through Immunization", regarding all provisions - H.R.6062, "To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes", regarding all provisions. - H.R.6952, "To direct the President to appoint a Medical Supplies Response Coordinator to coordinate the efforts of the Federal Government regarding the supply and distribution of certain supplies and equipment relating to COVID-19", regarding all provisions - S.3942, "Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act", regarding all provisions - S.3945, "Bring Entrepreneurial Advancements To Consumers Here In North America Act", regarding all provisions - S.3780, "HOME Act", regarding all provisions - S.3781, "PART Act", regarding all provisions - Issues related to diversity in clinical trials - Issues related to 340B - S.4613, The Contact Lens Rule Modernization Act, regarding all provisions - H.R.3107, "Improving Seniors Timely Access to Care Act of 2019, regarding all provisions - Executive Order 13948: Lowering Drug Prices by Putting America First - Executive Order 13939: Lowering Prices for Patients by Eliminating Kickbacks to Middlemen - Executive Order 13938: Increasing Drug Importation To Lower Prices for American Patients - Executive Order 13937: Access to Affordable Life-Saving Medications
Client expense: $860,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2020 · third_quarter · Pharmacy
Issues related to prescription drug importation, H.R. 5663 - the Safeguarding Therapeutics Act, S. 3201 - which extends the DEA's temporary scheduling of fentanyl-related substances; S. 4225 - the Safeguarding Therapeutics Act; Statement for the Record for House Committee on Energy & Commerce, Subcommittee on Consumer Protection & Commerce Hearing on Consumers Beware: Increased Risks During the COVID-19 Pandemic"; Statement on COVID-19 frauds and scams pertaining to medicines and medical supplies.
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Pharmacy
Opioids; CREATES Act; Drug Pricing H.R.6193 - 116th Congress Medication Access in Emergencies Act of 2020 Sponsor: Rep Pappas, Chris [D-NH-1] H.R.5691 - 116th Congress Transparency in Prescription Drug Advertising Act Sponsor: Rep Davids, Sharice [D-KS-3] H.R. 5894 - 116th Congress - Second Session Insulin Affordability Data Collection Act H.R. 5894 - 116th Congress - Second Session Transparency in Prescription Drug Advertising Act Sponsor: Rep. Sharice Davids (D-KS-03) H.R. 5927 - 116th Congress - Second Session Safe Medicine Act Sponsor: Rep. Bill Posey (R-FL-08) H.R. 5663 - 116th Congress - Second Session Safeguarding Therapeutics Act Sponsor: Rep Brett Guthrie (R-KY-02) H.R. 2477 - 116th Congress Beneficiary Enrollment Notification and Eligibility Simplification Act of 2019 Sponsor: Rep. Raul Ruiz (D-CA-36) H.R. 5749 - 116th Congress - Second Session Affordable Insulin for All Act Sponsor: Rep. Charlie Crist (D-FL-13) H.R. 6731 - 116th Congress - Second Session Securing America's Pharmaceutical Supply Chain Act Sponsor: Rep. Pete Stauber (R-MN-08) H.R. 5982 - 116th Congress - Second Session Safe Medicine Act Sponsor: Rep. Bill Posey (R-FL-08)
Client expense: Not reported · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Health Issues
- H.R. 863 - DXM Abuse Prevention Act of 2019, regarding all provisions - S. 726 - Personal Care Products Safety Act, regarding all provisions - Issues related to the regulation of over-the-counter drugs - Issues related to cosmetic regulatory reform - Issues related to cosmetic animal testing - Issues related to biosimilars - Issues related to maternal mortality - Issues related to contact lens safety - Issues related to medical product communications - Issues related to medical product review - Issues related to ingredient safety - Issues related to diversity in clinical trials - Issues related to health care pricing transparency - Issues related to peripheral artery disease - H.R. 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - Issues related to drug importation - S. 2543, "Prescription Drug Pricing Reduction Act of 2019", regarding all provisions - H.R. 19, "Lower Costs, More Cures Act of 2019", regarding all provisions - H.R. 748/ S. 3458, "'Coronavirus Aid, Relief, and. Economic Security Act'', regarding all provisions - H.R. 6074, "Coronavirus Preparedness and Response Supplemental Appropriations Act", regarding all provisions - H.R. 6201, "Families First Coronavirus Response Act", regarding all provisions - H.R. 3975, the Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 5663, the Safeguarding Therapeutics Act, regarding all provisions - Issues related to counterfeit health care goods - S. 3468, Preventing Essential Medical Device Shortages Act of 2020 - Issues related to counterfeit medical devices and combination products and authority to destroy counterfeit medical products - Issues related to reporting medical device shortages - Issues related to pandemic response - S. 2740, "Over the Counter Monograph Safety, Innovation, and Reform Act of 2019", regarding all provisions - H.R. 5279, "Cosmetic Safety Enhancement Act", regarding all provisions - H.R. 4296, "Safe Cosmetics and Personal Care Products Act of 2019", regarding all provisions - Issues related to social determinants of health - H.R. 5076/S. 1872, "Protecting Seniors Through Immunization", regarding all provisions - H.R.6062, "To amend certain provisions in the Federal Food, Drug, and Cosmetic Act relating to the discontinuance or interruption in the production of life-saving drugs so as to apply such provisions with respect to life-saving devices, and for other purposes", regarding all provisions. - H.R.6952, "To direct the President to appoint a Medical Supplies Response Coordinator to coordinate the efforts of the Federal Government regarding the supply and distribution of certain supplies and equipment relating to COVID-19", regarding all provisions - S.3942, "Securing America's Medical Supply Chain and Advancing the Production of Life Saving Medicines Act", regarding all provisions - S.3945, "Bring Entrepreneurial Advancements To Consumers Here In North America Act", regarding all provisions - S.3780, "HOME Act", regarding all provisions - S.3781, "PART Act", regarding all provisions - Issues related to diversity in clinical trials
Client expense: $1,760,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2020 · second_quarter · Health Issues
Issues related to value-based health care and modernization of fraud and abuse laws. Issues related to the sterilization of medical devices. Issues related to digital health, interoperability, and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. S. 3468, Preventing Essential Medical Device Shortages Act. P.L 116-136, Coronavirus Aid, Relief, and Economic Security Act, provisions related to device shortage reporting. H.R. 5663, Safeguarding Therapeutics Act. H.R. 6049, Medical Supply Chain Security Act. Issues related to telemedicine and remote patient monitoring. Issues related to global medical supply chains. Issues related to draft legislation for 21st Century Cures 2.0.
Client expense: $1,019,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Transportation, Dept of (DOT), U.S. Trade Representative (USTR)
2020 · second_quarter · Pharmacy
Opioids; CREATES Act; Drug Pricing; H.R. 6193 - 116th Congress - Second Session Medication Access in Emergencies Act of 2020 Sponsor: Rep. Chris Pappas (D-NH-01) H.R. 5578 - 116th Congress - Second Session Recall Unsafe Drugs Act of 2020 Sponsor: Rep. Rosa DeLauro (D-CT-03) H.R. 5691 - 116th Congress - Second Session Sponsor: Insulin Affordability Data Collection Act H.R. 5894 - 116th Congress - Second Session Transparency in Prescription Drug Advertising Act Sponsor: Rep. Sharice Davids (D-KS-03) H.R. 5927 - 116th Congress - Second Session Safe Medicine Act Sponsor: Rep. Bill Posey (R-FL-08) H.R. 5663 - 116th Congress - Second Session Safeguarding Therapeutics Act Sponsor: Rep. Brett Guthrie (R-KY-02) R. 4712 - 116th Congress - First Session Fairness in Orphan Drug Exclusivity Act Sponsor: Rep. Madeleine Dean (D-PA-04) H.R. 2477 - 116th Congress - First Session Beneficiary Enrollment Notification and Eligibility Simplification Act of 2019 Sponsor: Rep. Raul Ruiz (D-CA-36) H.R. 5749 - 116th Congress - Second Session Affordable Insulin for All Act Sponsor: Rep. Charlie Crist (D-FL-13) H.R. 6731 - 116th Congress - Second Session Securing America's Pharmaceutical Supply Chain Act Sponsor: Rep. Pete Stauber (R-MN-08) H.R. 5982 - 116th Congress - Second Session Safe Medicine Act Sponsor: Rep. Bill Posey (R-FL-08)
Client expense: $1,690,000 · 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), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office
2020 · second_quarter · Pharmacy
Opioids (Epidemic, Deterrence, Economic Impact Zones); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs Rx Rebates; Direct-to-Consumer Rx Advertising;Rx Rebates; Biosimilars; Drug approval; Drug patents, generic drugs, Part D Reform, Biosimilars, Civica RX H.R. 938 - 116th Congress (2019-2020) BLOCKING Act of 2019 Sponsor: Rep. Schrader, Kurt (D-OR-5) H.R.1520 - 116th Congress (2019-2020) Purple Book Continuity Act of 2019 Sponsor: Rep. Eshoo, Anna G. [D-CA-18] H.R.1503 - 116th Congress (2019-2020) Orange Book Transparency Act of 2019 Sponsor: Rep. Kelly, Robin L. [D-IL-2] H.R.1499 - 116th Congress (2019-2020) Protecting Consumer Access to Generic Drugs Act of 2019 Sponsor: Rep. Rush, Bobby L. [D-IL-1] H.R.965 - 116th Congress (2019-2020) CREATES Act of 2019 Sponsor: Rep. Cicilline, David N. [D-RI-1] H.R.3 - 116th Congress (2019-2020) Lower Drug Costs Now Act of 2019 Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6] H.R.275 - 116th Congress (2019-2020) Medicare Prescription Drug Price Negotiation Act of 2019 Sponsor: Rep. Welch, Peter [D-VT-At Large] H.R.448 - 116th Congress (2019-2020) Medicare Drug Price Negotiation Act Sponsor: Rep. Cummings, Elijah E. [D-MD-7] S. 3902 - 116th Congress (2019-2020) Expanding Access to Low Cost Generics act of 2019 Sponsor: Sen. Tina Smith (D-MN) HR 1046 - 116th Congress (2019-2020) Medicare Negotiation and Competitive Licensing Act of 2019 Sponsor: Rep. Doggett, Lloyd (D-TX-35) S. 2546 - 116th Congress (2019-2020) Safe Step Act Sen. Lisa Murkowski (R-AK) H.R. 19 - 116th Congress First Session Lower Costs, More Cures Act of 2019 Rep. Greg Walden (R-OR-02) H.R. 5691 - 116th Congress Second Session Insulin Affordability Data Collection Act H.R. 5894 - 116th Congress Second Session Transparency in Prescription Drug Advertising Act Rep. Sharice Davids (D-KS-03) H.R. 5927 - 116th Congress Second Session Safe Medicine Act Rep. Bill Posey (R-FL-08) H.R. 5663 - 116th Congress Second Session Safeguarding Theraputics Act Rep. Brett Guthrie (R-KY-2)
Client expense: $104,240 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Pharmacy
Issues related to Drug importation; Prescription Drug importation; H.R. 5663- Safeguarding Therapeutics Act; Lock & Suspend illicit domain registrars; restoring WHOIS access; H.Res. 875 - Expressing the sense of the House of Representatives that domain name registration information, referred to as "WHOIS" information, is critical to the protection of the United States national and economic security, intellectual property rights enforcement, cybersecurity, as well as the health, safety, and privacy of its citizens, and should remain readily accessible; H.R. 7002 - the Stop Coronavirus Scams Act; S. 3148 - Stopping Overdoses on Fentanyl Analogues Act .
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Pharmacy
Opioids; CREATES Act; Drug Pricing HR 4712 (116th Congress), Fairness in Orphan Drug Exclusivity Act, by Rep. Madeleine Dean (D-PA). Amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs. HR 5578 (116th Congress), Recall Unsafe Drugs Act of 2020, by Rep. Rosa DeLauro (D-CT). Provide for the mandatory recall of drugs regulated by the Food and Drug Administration. HR 5663 (116th Congress), Safeguarding Therapeutics Act, by Rep. Brett Guthrie (R-KY). Give authority to the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to destroy counterfeit devices. HR 5691 (116th Congress), Insulin Affordability Data Collection Act, by Rep. Angie Craig (D-MN). Require the Secretary to conduct a study and issue a report on the affordability of insulin. HR 5749 (116th Congress), Affordable Insulin for All Act, by Rep. Charlie Crist (D-FL). Establish the American Insulin Program to provide for lower prices for insulin drugs, to maintain effort throughout the insulin supply chain. HR 5894 (116th Congress), Transparency in Prescription Drug Advertising Act, by Rep. Sharice Davids (D-KS). Directs the Secretary of Health and Human Services to issue guidance requiring the list prices of drugs to be included in advertisements for such drugs. HR 5927 (116th Congress), Safe Medicine Act, by Rep. Bill Posey (R-FL). Directs the Secretary of Health and Human Services to study American dependence on unsafe Chinese pharmaceuticals and to empower the Food and Drug Administration to mandate drug recalls in the case of critical contamination. HR 5982 (116th Congress), Safe Medicine Act, by Rep. Bill Posey (R-FL). Directs the Secretary of Health and Human Services to study American dependence on Chinese pharmaceuticals and to empower the Food and Drug Administration to issue boxed warnings in the case of critical contamination. HR 6193 (116th Congress), Medication Access in Emergencies Act of 2020, by Rep. Chris Pappas (D-NH). Require group health plans and health insurance issuers offering group or individual health insurance coverage to provide benefits under such plan or such coverage for a 30-day refill of prescription drugs to individuals who reside in emergency areas during emergency periods. HR 6731 (116th Congress), Securing Americas Pharmaceutical Supply Chain Act, by Rep. Pete Stauber (R-MN). Require executive agencies to purchase pharmaceuticals from the United States.
Client expense: $350,000 · 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), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office
2020 · second_quarter · Consumer Issues/Safety/Products
HR 5663 - "Safeguarding Therapeutics Act". To amend the Federal Food, Drug, and Cosmetic Act to give authority to the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to destroy counterfeit devices.
Client expense: $34,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · first_quarter · Pharmacy
Opioids (Epidemic, Deterrence, Economic Impact Zones); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs Rx Rebates; Direct-to-Consumer Rx Advertising;Rx Rebates; Biosimilars; Drug approval; Drug patents, generic drugs, Part D Reform, Biosimilars, Civica RX H.R. 938 - 116th Congress (2019-2020) BLOCKING Act of 2019 Sponsor: Rep. Schrader, Kurt (D-OR-5) H.R.1520 - 116th Congress (2019-2020) Purple Book Continuity Act of 2019 Sponsor: Rep. Eshoo, Anna G. [D-CA-18] H.R.1503 - 116th Congress (2019-2020) Orange Book Transparency Act of 2019 Sponsor: Rep. Kelly, Robin L. [D-IL-2] H.R.1499 - 116th Congress (2019-2020) Protecting Consumer Access to Generic Drugs Act of 2019 Sponsor: Rep. Rush, Bobby L. [D-IL-1] H.R.965 - 116th Congress (2019-2020) CREATES Act of 2019 Sponsor: Rep. Cicilline, David N. [D-RI-1] H.R.3 - 116th Congress (2019-2020) Lower Drug Costs Now Act of 2019 Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6] H.R.275 - 116th Congress (2019-2020) Medicare Prescription Drug Price Negotiation Act of 2019 Sponsor: Rep. Welch, Peter [D-VT-At Large] H.R.448 - 116th Congress (2019-2020) Medicare Drug Price Negotiation Act Sponsor: Rep. Cummings, Elijah E. [D-MD-7] S. 3902 - 116th Congress (2019-2020) Expanding Access to Low Cost Generics act of 2019 Sponsor: Sen. Tina Smith (D-MN) HR 1046 - 116th Congress (2019-2020) Medicare Negotiation and Competitive Licensing Act of 2019 Sponsor: Rep. Doggett, Lloyd (D-TX-35) S. 2546 - 116th Congress (2019-2020) Safe Step Act Sen. Lisa Murkowski (R-AK) H.R. 19 - 116th Congress First Session Lower Costs, More Cures Act of 2019 Rep. Greg Walden (R-OR-02) H.R. 5691 - 116th Congress Second Session Insulin Affordability Data Collection Act H.R. 5894 - 116th Congress Second Session Transparency in Prescription Drug Advertising Act Rep. Sharice Davids (D-KS-03) H.R. 5927 - 116th Congress Second Session Safe Medicine Act Rep. Bill Posey (R-FL-08) H.R. 5663 - 116th Congress Second Session Safeguarding Theraputics Act Rep. Brett Guthrie (R-KY-2)
Client expense: $102,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · first_quarter · Health Issues
Issues related to value based health care and modernization of fraud and abuse laws. The Patient Affordability Value and Efficiency Act; issues pertaining to protections for value-based arrangements. Issues related to medical device, non-oral opioid pain treatment alternatives, including in implementation of the SUPPORT for Patients and Communities Act (P.L. 115-271) and H.R. 5172, the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act. Issues related to the sterilization of medical devices. Issues related to digital health, interoperability and electronic health records. Issues related to medical devices and COVID-19. Issues related to stroke care and routing protocol policies pertaining to emergent large vessel occlusion stroke. S. 3468, Preventing Essential Medical Device Shortages Act. H.R. 748, Coronavirus Aid, Relief, and Economic Security Act, provisions related to device shortage reporting. H.R. 5663, Safeguarding Therapeutics Act. H.R. 6049, Medical Supply Chain Security Act.
Client expense: $1,346,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Transportation, Dept of (DOT)
2020 · first_quarter · Pharmacy
Opioids (Epidemic, Deterrence, Economic Impact Zones); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs Rx Rebates; Biosimilars; Drug approval; Drug patents, generic drugs, Part D Reform, Biosimilars, Civica Rx H.R.1781 - 116th Congress (2019-2020) Payment Commission Data Act of 2019 Sponsor: Rep. Carter, Earl L. "Buddy" [R-GA-1] H.R.938 - 116th Congress (2019-2020) BLOCKING Act of 2019 Sponsor: Rep. Schrader, Kurt [D-OR-5] H.R.1520 - 116th Congress (2019-2020) Purple Book Continuity Act of 2019 Sponsor: Rep. Eshoo, Anna G. [D-CA-18] H.R.1503 - 116th Congress (2019-2020) Orange Book Transparency Act of 2019 Sponsor: Rep. Kelly, Robin L. [D-IL-2] H.R.1499 - 116th Congress (2019-2020) Protecting Consumer Access to Generic Drugs Act of 2019 Sponsor: Rep. Rush, Bobby L. [D-IL-1] H.R.965 - 116th Congress (2019-2020) CREATES Act of 2019 Sponsor: Rep. Cicilline, David N. [D-RI-1] H.R.3 - 116th Congress (2019-2020) Lower Drug Costs Now Act of 2019 Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6] H.R.275 - 116th Congress (2019-2020) Medicare Prescription Drug Price Negotiation Act of 2019 Sponsor: Rep. Welch, Peter [D-VT-At Large] H.R.448 - 116th Congress (2019-2020) Medicare Drug Price Negotiation Act Sponsor: Rep. Cummings, Elijah E. [D-MD-7] H.R.1046 - 116th Congress (2019-2020) Medicare Negotiation and Competitive Licensing Act of 2019 Sponsor: Rep. Doggett, Lloyd [D-TX-35] S. 3092 -- 116th Congress (2019-2020) Expanding Access to Low-Cost Generics Act of 2019 Sponsor: Sen. Tina Smith (D-MN) S. 2546 - 116th Congress (2019-2020) Safe Step Act Sen. Lisa Murkowski (R-AK) S. 3374 - 116th Congress - Second Session Protecting Jessica Grubb's Legacy Act Sen. Joe Manchin (D-WV) H.R. 19 - 116th Congress - First Session Lower Costs, More Cures Act of 2019 Rep. Greg Walden (R-OR-02) H.R. 6193 - 116th Congress - Second Session Medication Access in Emergencies Act of 2020 Rep. Chris Pappas (D-NH-01) H.R. 5578 - 116th Congress - Second Session Recall Unsafe Drugs Act of 2020 Rep. Rosa DeLauro (D-CT-03) H.R. 5691 - 116th Congress - Second Session Insulin Affordability Data Collection Act H.R. 5894 - 116th Congress - Second Session Transparency in Prescription Drug Advertising Act Rep. Sharice Davids (D-KS-03) H.R. 5927 - 116th Congress - Second Session Safe Medicine Act Rep. Bill Posey (R-FL-08) H.R. 5663 - 116th Congress - Second Session Safeguarding Therapeutics Act Rep. Brett Guthrie (R-KY-02) R. 4712 - 116th Congress - First Session Fairness in Orphan Drug Exclusivity Act Rep. Madeleine Dean (D-PA-04) H.R. 2477 - 116th Congress - First Session Beneficiary Enrollment Notification and Eligibility Simplification Act of 2019 Rep. Raul Ruiz (D-CA-36)
Client expense: $1,880,000 · 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), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office
2020 · first_quarter · Health Issues
- H.R. 863 - DXM Abuse Prevention Act of 2019, regarding all provisions - S. 726 - Personal Care Products Safety Act, regarding all provisions - Issues related to the regulation of over-the-counter drugs - Issues related to cosmetic regulatory reform - Issues related to cosmetic animal testing - Issues related to biosimilars - Issues related to maternal mortality - Issues related to contact lens safety - Issues related to medical product communications - Issues related to medical product review - Issues related to ingredient safety - Issues related to diversity in clinical trials - Issues related to health care pricing transparency - Issues related to peripheral artery disease - H.R. 3, "Elijah E. Cummings Lower Drug Costs Now Act", regarding all provisions - Issues related to drug importation - S. 2543, "Prescription Drug Pricing Reduction Act of 2019", regarding all provisions - H.R. 19, "Lower Costs, More Cures Act of 2019", regarding all provisions - H.R. 748/ S. 3458, "'Coronavirus Aid, Relief, and. Economic Security Act'', regarding all provisions - H.R. 6074, "Coronavirus Preparedness and Response Supplemental Appropriations Act", regarding all provisions - H.R. 6201, "Families First Coronavirus Response Act", regarding all provisions - H.R. 3975, the Contact Lens Prescription Verification Modernization Act, regarding all provisions - H.R. 5663, the Safeguarding Therapeutics Act, regarding all provisions - Issues related to counterfeit health care goods - S. 3468, Preventing Essential Medical Device Shortages Act of 2020 - Issues related to counterfeit medical devices and combination products and authority to destroy counterfeit medical products - Issues related to reporting medical device shortages - Issues related to pandemic response - S. 2740, "Over the Counter Monograph Safety, Innovation, and Reform Act of 2019", regarding all provisions - H.R. 5279, "Cosmetic Safety Enhancement Act", regarding all provisions - H.R. 4296, "Safe Cosmetics and Personal Care Products Act of 2019", regarding all provisions
Client expense: $1,480,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, White House Office
2020 · first_quarter · Pharmacy
Issues related to H.R. 5663- Safeguarding Therapeutics Act; S. 3384- Lowering Prescription Drug Prices for America's Seniors and Families Act of 2020; drug importation; prescription drug importation; counterfeit drugs; counterfeit medical supplies; price gouging; COVID-19
Client expense: Not reported · Firm income: $5,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · first_quarter · Pharmacy
Opioids (Epidemic, Deterrence, Economic Impact Zones); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs; Rx Rebates; Biosimilars; Drug Approval; Drug Patents; Generic Drugs; Part D Reform, Civica Rx HR 3 (116th Congress), Lower Drug Costs Now Act of 2019, by Rep. Frank Pallone, Jr. (D-NJ). To establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees, and for other purposes. HR 19 (116th Congress), Lower Costs, More Cures Act of 2019, by Rep. Greg Walden (R-OR). To provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, the Food and Drug Administration, and for other purposes. HR 275 (116th Congress), Medicare Prescription Drug Price Negotiation Act of 2019, by Rep. Peter Welch (D-VT). 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. HR 448 (116th Congress), Medicare Drug Price Negotiation Act, by Rep. Elijah Cummings (D-MD). To amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes. HR 938 (116th Congress), Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (the BLOCKING Act) of 2019, by Rep. Kurt Schrader (D-OR). To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes. HR 965 (116th Congress), CREATES Act of 2019, by Rep. David Cicilline (D-RI). To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1046 (116th Congress), Medicare Negotiation and Competitive Licensing Act of 2019, by Rep. Lloyd Doggett (D-TX). To amend title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate prices of prescription drugs furnished under part D of the Medicare program. HR 1499 (116th Congress), Protecting Consumer Access to Generic Drugs Act of 2019, by Rep. Bobby Rush (D-IL). To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes. HR 1503 (116th Congress), Orange Book Transparency Act of 2019, by Rep. Robin Kelly (D-IL). To amend the Federal Food, Drug, and Cosmetic Act regarding the list under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, and for other purposes. HR 1520 (116th Congress), Purple Book Continuity Act of 2019, by Rep. Anna Eshoo (D-CA). To amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes. HR 1781 (116th Congress), Payment Commission Data Act of 2019, by Rep. Earl Carter (D-GA). To amend titles XVIII and XIX of the Social Security Act to provide the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information. HR 4712 (116th Congress), Fairness in Orphan Drug Exclusivity Act, by Rep. Madeleine Dean (D-PA). To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes. HR 5578 (116th Congress), Recall Unsafe Drugs Act of 2020, by Rep. Rosa DeLauro (D-CT). To provide for the mandatory recall of drugs regulated by the Food and Drug Administration. HR 5663 (116th Congress), Safeguarding Therapeutics Act, by Rep. Brett Guthrie (R-KY). To amend the Federal Food, Drug, and Cosmetic Act to give authority to the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to destroy counterfeit devices. HR 5691 (116th Congress), Insulin Affordability Data Collection Act, by Rep. Angie Craig (D-MN). To require the Secretary to conduct a study and issue a report on the affordability of insulin. HR 5894 (116th Congress), Transparency in Prescription Drug Advertising Act, by Rep. Sharice Davids (D-KS). To direct the Secretary of Health and Human Services to issue guidance requiring the list prices of drugs to be included in advertisements for such drugs. HR 5927 (116th Congress), Safe Medicine Act, by Rep. Bill Posey (R-FL). To direct the Secretary of Health and Human Services to study American dependence on unsafe Chinese pharmaceuticals and to empower the Food and Drug Administration to mandate drug recalls in the case of critical contamination. HR 6193 (116th Congress), Medication Access in Emergencies Act of 2020, by Rep. Chris Pappas (D-NH). To amend title XXVII of the Public Health Service Act to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide benefits under such plan or such coverage for a 30-day refill of prescription drugs to individuals who reside in emergency areas during emergency periods. S 2546 (116th Congress), Safe Step Act, by Sen. Lisa Murkowski (R-AK). To amend the Employee Retirement Income Security Act of 1974 to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes. S 3092 (116th Congress), Expanding Access to Low-Cost Generics Act of 2019, by Sen. Tina Smith (D-MN). To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes.
Client expense: $230,000 · 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), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office
2020 · first_quarter · Consumer Issues/Safety/Products
HR 5663 - "Safeguarding Therapeutics Act". To amend the Federal Food, Drug, and Cosmetic Act to give authority to the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to destroy counterfeit devices.
Client expense: $34,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE