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Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018
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Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 This bill amends the Federal Food, Drug, and Cosmetic Act to substantially revise how over-the-counter (OTC)drugs are approved.
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Filing registrants (28)
Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 518.
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 H6227-6235)
Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by voice vote.(text: CR H6227-6235)
DEBATE - The House proceeded with forty minutes of debate on H.R. 5333.
Considered under suspension of the rules. (consideration: CR H6227-6237)
Mr. Latta moved to suspend the rules and pass the bill, as amended.
Placed on the Union Calendar, Calendar No. 640.
Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 115-827.
Congress.gov source codes: 5000, H12200
Ordered to be Reported (Amended) by Voice Vote.
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2019 · first_quarter · Pharmacy
Repeals a requirement enacted into law as part of the PPACA of 2010 that requires consumers to obtain a prescription in order to utilize their FSA's and HSA's to purchase over-the-counter OTC medicines. FDA's proposed changes to generic drug labeling. "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018", H.R. 5333. "Over-the-Counter Drug Safety, Innovation, and Reform Act", S. 2315.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2019 · first_quarter · Consumer Issues/Safety/Products
Monitoring FDA regulation of cosmetics and Consumer Product Safety issues. Monitor data breach notification, cyber-security and digital privacy proposals. H.R.5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018.
Client expense: Not reported · Firm income: $50,000
Government targets: Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Office of the Vice President of the United States, SENATE, U.S. Trade Representative (USTR)
2019 · first_quarter · Pharmacy
Repeals a requirement enacted into law as part of the PPACA of 2010 that requires consumers to obtain a prescription in order to utilize their FSA's and HSA's to purchase over-the-counter OTC medicines. FDA's proposed changes to generic drug labeling. "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018", H.R. 5333. "Over-the-Counter Drug Safety, Innovation, and Reform Act", S. 2315.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Food Industry (safety, labeling, etc.)
OTC monograph legislation; S.2315, Over-the-Counter Drug Safety, Innovation, and Reform Act and H.R.5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. Implementation of the Food Safety Modernization Act (FSMA). Cleaning product labeling.
Client expense: $250,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Natl Security Council (NSC), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Health Issues
Health and Human Services Department Reform Health Care Reform (access to dental care, other dental-related issues) Affordable Care Act Repeal and Replace (dental-related programs) Better Care Reconciliation Act of 2017 (H.R. 1628, nature of a substitute) Graham-Cassidy health reform proposal (H.R. 1628, nature of a substitute) Childrens Health Insurance Program (CHIP) reauthorization H.R. 6-Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act H.R. 860-HEALTHIER Act of 2017 H.R. 1606-Dentist and Optometric Care Access Act (DOC Access Act) H.R. 1628-American Health Care Act of 2017 H.R. 1876-Good Samaritan Health Professionals Act of 2017 H.R. 2422-Action for Dental Health Act of 2017 H.R. 2430-FDA Reauthorization Act of 2017 H.R. 3921-HEALTHY KIDS Act H.R. 4684-Ensuring Access to Quality Sober Living Act of 2018 H.R. 5197-Alternatives to Opioids (ALTO) in the Emergency Department Act H.R. 5261-TEACH to Combat Addiction Act of 2018 H.R. 5327-Comprehensive Opioid Recovery Centers Act of 2018 H.R. 5333-Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 H.R. 5687-Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act H.R. 5774-Combatting Opioid Abuse for Care in Hospitals (COACH) Act H.R. 5776-Medicare and Opioid Safe Treatment (MOST) Act H.R. 5806-21st Century Tools for Pain and Addiction Treatments H.R. 5812-Creating Opportunities that Necessitate New and Enhanced Connections that Improve Opioid Navigating Strategies (CONNECTIONS) Act H.R. 6689-Ensuring Lasting Smiles Act H.R. 7000-Tribal Tax Empowerment and Jobs Act of 2018 S. 934-FDA Reauthorization Act of 2017 S. 1827-KIDS Act of 2017 S. 2315-Over-the-Counter Drug Safety, Innovation, and Reform Act S. 2456-CARA 2.0 Act of 2018 S. 2680-Opioid Crisis Response Act of 2018 S. 3016-Action for Dental Health Act of 2018
Committee Consideration and Mark-up Session Held.
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
| March 19, 2018 |
| Democratic |
| CO |
| Doris O. Matsui | Democratic | CA |
| Gene Green | Democratic | TX |
| Kurt Schrader | Democratic | OR |
| Michael C. Burgess | Republican | TX |
Client expense: $530,000 · Firm income: Not reported
Government targets: Drug Enforcement Administration (DEA), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), Office of Natl Drug Control Policy (NDCP), SENATE, Treasury, Dept of
2018 · fourth_quarter · Pharmacy
- OTC drugs, devices and cosmetics - OTC monograph reform - S.1113, Personal Care Products Safety Act - S.2315/H.R.5333, Over-the-Counter Drug Safety, Innovation, and Reform Act
Client expense: $693,588 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)
2018 · fourth_quarter · Health Issues
H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 6574: Medicare Fair Drug Pricing Act of 2018 - Provisions related to drug pricing HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act HR 7328 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 HR 394/S85 - Restoring Access to Medication Ac HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 Medicare Doughnjt hole -House/Senate Labor HHS AppropriationsHouse/Senate DoD AppropriationsDoggett bill Trump Administration IPI proposal, Trump Administration proposed changes to six protected classes. HR6378, Pandemic and All Hazards Preparedness and Advancing Innovation Act; HR4993/S3253, Vaccine Access Improvement Act; HR 4297/S2103, Protecting Seniors Through Immunization Act; H.R.4710 - 340B PAUSE ActH.R.4297 - Protecting Seniors Through Immunization Act of 2017 S. 3477 - Protecting Seniors through Immunization Act S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees -Know the Lowest Price Act of 2018Medicare Part D Six Protected Classes HHS Proposal on Medicare Part B International Pricing Index (IPI)340B Drug Discount Program S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling S. 3775: Affordable Drug Manufacturing Act of 2018 Drug cost and pricing policy issues Transparency 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 Compulsory licensing policy issues Foreign reference pricing policy issues 340B drug discount program policy issues Bipartisan Budget Act of 2018 (Public Law 115-123) - Part D provisions 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)
Client expense: $920,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Health Issues
Issues related to S.2315 "Over-the-Counter Drug Safety, Innovation, and Reform Act; general issues related to drug pricing;issues related to cosmetic regulations; issues related to insulin pricing;issues related H.R. 6378 "Pandemic and All Hazards Preparedness (PAHPA)Advancing Innovation Act"; issues related to Medicare Part D; issues related to flu and Veterans Affairs; issues related to seasonal influenza vaccination; issues related to 340B Reform; issues related to Drug Importation; issues related to vaccine safety;issues related to HR5333 "Over-the-Counter Monograph Safety, Innovation, and reform Act of 2018; issues related to HR2212 "CREATES Act of 2017";issues related to HR 2439 "Fair Accountability and Innovation Research Drug Act of 2017"; issues related S. 2852 "Pandemic and All-Hazards Preparedness and Advancing Innovation Act (PAHPA) of 2018"; issues related to PAHPA reauthorization; and issues related to S.2465 "Sickle Cell Disease and other Heritable Blood Disorders Research, Surveillance, Prevention and Treatment Act of 2018"
Client expense: $790,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Security Council (NSC), Office of Management & Budget (OMB), SENATE
2018 · fourth_quarter · Health Issues
H.R.6378/S.2852: Reauthorization of the Pandemic All-Hazards Preparedness Act (PAHPA). H.R.5333: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
H.R.5333: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. H.R.6378/S.2852: Reauthorization of PAHPA (Pandemic All-Hazards Preparedness Act).
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
H.R.5333: Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
Issues related to the over the counter drug monograph process including H. R. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 and S. 2315, the Over-the-Counter Drug Safety, Innovation, and Reform Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · 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. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 and S. 2315, the Over-the-Counter Drug Safety, Innovation, and Reform Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · 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 2019 Ag-FDA Appropriations bills and reports (H.R. 5961, S.2976); H.Res.282 on sunscreen use in schools; Sunscreen provisions in H.R. 5333, the Over-the-Counter Monograph Safety, Innovation and Reform Act of 2018, and S.2315, the Over-the-Counter Drug Safety, Innovation, and Reform Act; issues related to state bans on sunscreen ingredients.
Client expense: Not reported · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Lobby members of Congress to support H. Res. 282 to encourage proper sun safety practices for youth under care of schools and camps. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 2871, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077, Restoring Patients Voice Act. Support H.R. 1316, Prescription Drug Price Transparency Act. Support H.R. 2051, Fair Access for Safe and Timely Generics Act. Support H.R. 2212/S. 974, Creating and Restoring Equal Access to Equivalent Samples Act. Support H.R. 2999, Patients Access to Treatments Act. Support H.R. 3928, the Truth in Healthcare Marketing Act of 2017. Support S. 637, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support H.R. 5958, Phair Pricing Act. Support H.R. 6689/S. 3368, Ensuring Lasting Smiles Act. Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 4841/H.R. 5773/Section 6062 of H.R. 6 (SUPPORT for Patients & Communities Act), Standardizing Electronic Prior Authorization for Safe Prescribing Act and S. 2908, Electronic Prior Authorization in Medicare Part D Act. Support sunscreen related provisions in S. 2315, OTC Drug Safety, Innovation & Reform Act/H.R. 5333, OTC Monograph Safety, Innovation, & Reform Act. Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Advocate for access to dermatological procedures for veterans through the Veterans Choice Program. Advocate for the continued funding of Community Health Centers. Advocate against including physician advocacy and membership organization in the Physician Payment Sunshine Act requirements as originally included in S. 3000; advocated against inclusion in S. Amendment 4013 to H.R. 6.
Client expense: $360,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Pharmacy
Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Support H.R. 2871, Preserving Patient Access to Compounded Medications Act. Support H.R. 1316, Prescription Drug Price Transparency Act Support S. 637, C-THRU Act. Support H.R. 5958, Phair Pricing Act Support sunscreen related provisions in S. 2315, OTC Drug Safety, Innovation & Reform Act/H.R. 5333, OTC Monograph Safety, Innovation, & Reform Act; provisions also included in H.R. 7328, Pandemic and All-Hazards Preparedness and Advancing Innovation Act.
Client expense: $360,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Health Issues
- S. 469/H.R. 1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. - S. 771/H.R. 1776, "Improving Access To Affordable Prescription Drugs Act", regarding all provisions. - H.R. 575, "Cosmetic Modernization Amendments of 2017", regarding all provisions. - H.R. 1271, "DXM Abuse Prevention Act of 2017", regarding all provisions. - S. 404/H.R. 1736, "To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.", regarding all provisions. - Issues regarding drug pricing. - Issues related to diagnostic reform. - S 260/SJ Res 17/HR 849, Protecting Seniors' Access to Medicare Act of 2017, regarding all provisions - S 251/SJ Res 16, Protecting Medicare from Executive Action Act of 2017, regarding all provisions - S 204/HR 878, Right to Try Act of 2017, regarding all provisions - HR 2026, Pharmaceutical Information Exchange Act, regarding all provisions - HR 1703, Medical Product Communications Act of 2017, regarding all provisions - Issues related to VA procurement of medical devices - HR 2474, Medical Product Review Harmonization Act, regarding all provisions - HR 2144, Risk Based Classification of Accessories Act - Issues related to AMA resolution 208(A-16) regarding attorney ads on drug side effects - S.1113, "Personal Care Products Safety Act", regarding all provisions - HR 2790, "Humane Cosmetics Act", regarding all provisions - HR 3271, "Protecting Access to Diabetes Supplies Act", regarding all provisions - Issues regarding medical device repeal - Issues regarding NIH Funding - HR 2164, "Medical Device Safety Act", regarding all provisions - Issues related to 340B - Issues related to HIV vaccines - S. 2852, "Pandemic & All Hazards Preparedness and Advancing Innovations Act of 2018", regarding all provisions. - Issues related to reauthorization of the Pandemic All-Hazards Preparedness Act programs. (House version) - HR 5492, "MOTHER Act of 2018", regarding all provisions. - Issues related to access to essential surgery - Issues related to contact lens safety - HR 6, "SUPPORT for Patients and Communities Act", regarding all provisions. - S. 2315, "Over-the-Counter Drug Safety, Innovation, and Reform Act", regarding all provisions. - HR 5333 "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018", regarding all provisions. - Issues related to antimicrobial resistance - Issues related to regulations on medication product packaging - H.R. 6294, " Re-Valuing Anti-Microbial Products Act of 2018", regarding all provisions - H.R. 1318, "Preventing Maternal Deaths Act of 2018", regarding all provisions
Client expense: $2,340,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office
2018 · fourth_quarter · Consumer Issues/Safety/Products
Implementation of the Sunscreen Innovation Act (PL-113-195). Renewal and improvement of the Sunscreen Innovation Act in context of possible reform of the Over-the-Counter drug process at FDA, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018, H.R. 5333, S. 2315. Legislation to reform the Over the Counter drug monograph process
Client expense: $410,000 · Firm income: Not reported
Government targets: Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Health Issues
Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products. Implementation of the 21st Century Cures Act (P.L.114-255). S.1113, Personal Care Products Safety Act. S.2003, FDA Cosmetic Safety and Modernization Act. S.2315, Over-the-Counter Drug Safety, Innovation, and Reform Act. H.R.5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. H.R.6, SUPPORT for Patients and Communities Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
Issues related to Over the Counter (OTC) Monograph reform, influenza, and drug pricing; S.2852/H.R.6378, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; S.2434/H.R.5554, Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (P.L.115-234); S.2315, Over-the-Counter Drug Safety, Innovation, and Reform Act; H.R.5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
Monitored issues related to H.R. 7217, IMPROVE Act. H.R. 2422, Action for Dental Health Act of 2017, S. 3016, Action for Dental Health Act of 2018 and issues regarding access to dental services. S.2315, Over-the-Counter Drug Safety, Innovation, and Reform Act; H.R.5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 and issues related to over the counter medications. Issues related to opioids, including prescription fill limits, prescription drug monitoring programs, mandatory compulsory education and prescriber patterns. H.R 6, SUPPORT for Patients and Communities Act. S. 2680, The Opioid Crisis Response Act of 2018.
Client expense: Not reported · Firm income: $63,750
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · fourth_quarter · Food Industry (safety, labeling, etc.)
OTC monograph legislation; S.2315, Over-the-Counter Drug Safety, Innovation, and Reform Act and H.R.5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. Implementation of the Food Safety Modernization Act (FSMA). Cleaning product labeling.
Client expense: $230,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Natl Economic Council (NEC), Natl Security Council (NSC), SENATE, State, Dept of (DOS), Treasury, Dept of, U.S. Trade Representative (USTR)
2018 · fourth_quarter · Food Industry (safety, labeling, etc.)
OTC monograph legislation S.2315 Over-the-Counter Drug Safety, Innovation, and Reform Act H.R.5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 Implementation of FSMA Cleaning product labeling
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Pharmacy
H.R. 1038/S. 413 - Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.592/S. 109 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 1316 - Prescription Drug Price Transparency Act H.R. 623 - Fairness to Pet Owners Act Letter to HHS/CMS on direct and indirect remuneration (DIR) fees Discussions with House committees on pharmacy benefit managers (PBMs) H.R.6 - SUPPORT for Patients and Communities Act - FDA Guidelines Section 3004 Letter S. 2680 - Opioid Crisis Response Act of 2018 H.R. 6733, Know the Cost Act of 2018 S. 2553, Know the Lowest Price Act S. 2554, the Patient Right to Know Drug Prices Act H.R. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018
Client expense: $160,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Federal Reserve System, HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Manufacturing
OTC Drug Review Monograph H.R. 5333/S.2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act. Legislation to update and modernize the Over-the-Counter Drug Review Monograph system, which regulates the manufacture, labeling, and marketing of specific over-the-counter (OTC) drugs. H.R. 7328 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018 H.R.6903 - Safe Cosmetics and Personal Care Products Act of 2018
Client expense: $197,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, Treasury, Dept of
2018 · fourth_quarter · Pharmacy
Repeals a requirement enacted into law as part of the PPACA of 2010 that requires consumers to obtain a prescription in order to utilize their FSA's and HSA's to purchase over-the-counter OTC medicines. FDA's proposed changes to generic drug labeling. "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018", H.R. 5333. "Over-the-Counter Drug Safety, Innovation, and Reform Act", S. 2315.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Alcohol and Drug Abuse
S.892 Opioid Addiction Prevention Act of 2017 H.R.4408 - Opioid Addiction Prevention Act of 2017 H.R.3964 - Opioid Addiction Prevention Act of 2017 H.R. 5219 - Opioid Prescription Verification Act H.R. 4275 - Empowering Pharmacists in the Fight Against Opioids Act H.R. 4275 - Safe Disposal of Unused Medication Act H.R. 2063 - Opioid Preventing Abuse through Continuing Education Act S. 3120 Helping to End Addiction and Lessen (HEAL) Substance Use Disorders Act of 2018 S. 2789, Substance Abuse Prevention Act of 2018 S. 2838, Using Data to Prevent Opioid Diversion Act of 2018 S. 2460, Every Prescription Conveyed Security Act of 2018 H.R. 5812, Creating Opportunities that Necessitate New and Enhanced Connections That Improve Opioid Navigation Strategies Act (CONNECTIONS) Act H.R. 4275, Empowering Pharmacists in the Fight Against Opioid Abuse Act H.R. 3528, Every Prescription Conveyed Securely Act H.R. 4841, Standardizing Electronic Prior Authorization for Safe Prescribing Act H.R. 5675, To amend title XVIII of the Social Security Act to require prescription drug plan sponsors under the Medicare program to establish drug management programs for at-risk beneficiaries H.R. 5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act H.R. 5687, Securing Opioids and Unused Narcotics with Deliberate Disposal and Packaging Act H.R.6 - SUPPORT for Patients and Communities Act S. 2465 - AIDD Act S 2837 - Preventing Drug Diversion Act S. 3282 - DEA Order Clearinghouse Act S. 2383 - Using Data to Prevent Opioid Diversion Act
Client expense: $640,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Drug Enforcement Administration (DEA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
OTC drugs and cosmetics reform, including Personal Care Products Safety Act (S. 1113), FDA Cosmetic Safety and Modernization Act (S. 2003), Modernization of Cosmetics Regulation Act of 2018 (Senate HELP Committee Discussion Draft), Over-the-Counter Drug Safety, Innovation and Reform Act (S. 2315), and Over-the-Counter Monograph Safety, Innovation and Reform Act of 2018 (H.R. 5333)
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Consumer Issues/Safety/Products
In support of passage of H.R. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act, legislation to update the US Food & Drug Administration's OTC monograph process.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Medical/Disease Research/Clinical Labs
H.R. 5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Consumer Issues/Safety/Products
Modernization of Cosmetic Regulations H.R. 575 - Cosmetic Modernization Amendments of 2017 S. 1113 - Personal Care Products Safety Act Safety of Cosmetic/Personal Care/Household Cleaning Products & Ingredients FDA Regulation of OTC Drugs OTC Drug Monograph Reform - H.R. 5333 & S. 2315 Ingredient Disclosure - Cleaning Products
Client expense: Not reported · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Government Issues
Food and Drug Administration and cleaning products (H.R. 5333, H.R. 7328, H.R. 695, S. 2315)
Client expense: $60,000 · Firm income: Not reported
Government targets: Consumer Product Safety Commission (CPSC), Environmental Protection Agency (EPA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Consumer Issues/Safety/Products
Issues related to the study and approval of certain over the counter antimicrobial hand soaps. S. 2315, Over-the-Counter Drug Safety, Innovation, and Reform Act and H.R. 5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. Issues related to regulation and safe use of liquid laundry detergent packets. Issues related to Consumer Product Safety Commission nominations. Issues related to cleaning product ingredients labeling,disclosure and transparency.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Chemicals/Chemical Industry
Issues related to the study and approval of certain over the counter antimicrobial hand soaps. S. 2315, Over-the-Counter Drug Safety, Innovation, and Reform Act and H.R. 5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. Issues related to cleaning product ingredients labeling,disclosure and transparency. H.R. 7328 Over-the-Counter Monograph Safety pandemic and all hazards preparedness and advancing innovation Act.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Food Industry (safety, labeling, etc.)
Issues related to the study and approval of certain over the counter antimicrobial hand soaps. S. 2315, Over-the-Counter Drug Safety, Innovation, and Reform Act and H.R. 5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. Issues related to cleaning product ingredients,labeling,disclosure and transparency.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Consumer Issues/Safety/Products
Lobbying on behalf of P&G in connection with H.R. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act.
Client expense: Not reported · Firm income: Not reported
2018 · third_quarter · Health Issues
Legislative outreach and monitoring related to healthcare issues. S. 2315, Over-the-Counter Drug Safety, Innovation, and Reform Act. H.R. 5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018.
Client expense: Not reported · Firm income: $10,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
H.R. 6: SUPPORT for Patients and Communities Act - To provide for opioid use disorder prevention, recovery, and treatment, and for other purposes H.R. 449: Synthetic Drug Awareness Act: Provisions related to synthetic drug report H.R. 749: Lower Drug Costs through Competition Act - Provisions related to generic drug approvals H.R. 878: Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 1245: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation H.R. 1480: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation H.R. 1628: American Health Care Act of 2017 - Provisions related to the biopharmaceutical industry including repeal of brand pharmaceutical manufacturer fee and individual and employer mandates, insurance affordability provisions, and Medicaid reforms H.R. 1776: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing H.R. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2051: FAST Generics Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2063: Opioid Preventing Abuse through Continuing Education (PACE) Act of 2017 - Provisions related to prescriber training H.R. 2212: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems H.R. 4710: 340B Protecting Access for the Underserved and Safety-net Entities Act or PAUSE Act - Provisions related to the 340B program H.R. 4482: Opioid Abuse Deterrence, Research, and Recovery Act of 2017 - Provisions related to prescriber requirements H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5202: Ensuring Patient Access to Substance Use Disorder Treatments Act of 2018 - Provisions related to drug delivery H.R. 5228: SCREEN Act - Provisions related to drug recall authority H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5582: Abuse Deterrent Access Act of 2018 H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5788: Synthetics Trafficking and Overdose Prevention Act of 2018 or STOP Act of 2018 H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 6143: Patient Right to Know Drug Prices Act - Provisions related to drug pricing H. Res. 949: Providing for consideration of the bill (H.R. 6) to provide for opioid use disorder prevention, recovery, and treatment, and for other purposes; providing for consideration of the bill (H.R. 5797) to amend title XIX of the Social Security Act to allow States to provide under Medicaid services for certain individuals with opioid use disorders in institutions for mental diseases; and providing for consideration of the bill (H.R. 6082) to amend the Public Health Service Act to protect the confidentiality of substance use disorder patient records S. 64: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 92: Safe and Affordable Drugs from Canada Act of 2017 - Provisions related to importation S. 469: Affordable and Safe Prescription Drug Importation Act - Provisions related to importation S. 771: Improving Access to Affordable Prescription Drugs Act - Provisions related to drug pricing S. 974: CREATES Act of 2017 - Provisions related to Risk Evaluation and Mitigation Strategies (REMS) and limited distribution systems S. 1131: Fair Accountability and Innovative Research Drug Pricing Act of 2017 - Provisions related to drug pricing S. 1327: SITSA Act - Provisions related to controlled substances S. 2157: Drug-Price Transparency in Communications Act S. 2312: HELP Act - Provisions related to 340B program S. 2453: Ensuring the Value of the 340B Program Act of 2018 - Provisions to increase transparency in the 340B program S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - To ensure that health insurance issuers and group health plans do not prohibit pharmacy providers from providing certain information to enrollees S. 2665: A bill to require guidance on how the Food and Drug Administration will consider claims of opioid sparing and on the conditions under which the Food and Drug Administration will consider misuse and abuse of drugs in making certain determinations of safety S. 3519: A bill to establish a process for the Food and Drug Administration to determine whether to modify the labeling of drugs whose labeling may be outdated, including drugs with accepted uses that are not reflected in the approved labeling Drug cost and pricing policy issues Transparency 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 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 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) HR6, SUPPORT for Patients and Communities Act, Provisions related to BBA technical correction (Part D) HR 394/S 85 - Restoring Access to Medication Act of 2017Vaccine manufacturing practices HR 4297/S2103, Protecting Seniors Through Immunization Act; HR4993/S3253, Vaccine Access Improvement Act; HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018Durbin/Grassley Amendment HR 6199 - Restoring Access to Medication and Modernizing Health Savings Accounts Act of 2018 H.R.6378 To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act' S.2852 Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018
Client expense: $1,130,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Food Industry (safety, labeling, etc.)
OTC monograph legislation; S.2315, Over-the-Counter Drug Safety, Innovation, and Reform Act and H.R.5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. Implementation of the Food Safety Modernization Act (FSMA). Cleaning product labeling.
Client expense: $240,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Energy, Dept of, Environmental Protection Agency (EPA), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), Treasury, Dept of
2018 · third_quarter · Pharmacy
- OTC drugs, devices and cosmetics - OTC monograph reform - S.1113, Personal Care Products Safety Act - S.2315/H.R.5333, Over-the-Counter Drug Safety, Innovation, and Reform Act
Client expense: $810,232 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Consumer Product Safety Commission (CPSC), Energy, Dept of, Environmental Protection Agency (EPA), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Homeland Security, Dept of (DHS), Intl Trade Administration (ITA), Justice, Dept of (DOJ), Natl Security Council (NSC), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), Transportation, Dept of (DOT), Treasury, Dept of, U.S. Agency for International Development (USAID), U.S. Customs & Border Protection, U.S. Immigration & Customs Enforcement (ICE), U.S. International Trade Commission (ITC), U.S. Trade Representative (USTR)
2018 · third_quarter · Health Issues
H.R. 1606, The Dental and Optometric Care Access Act. H.R. 2422, Action for Dental Health Act of 2017, S. 3016, Action for Dental Health Act of 2018 and issues regarding access to dental services. S.2315, Over-the-Counter Drug Safety, Innovation, and Reform Act; H.R.5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 and issues related to over the counter medications. Issues related to opioids, including prescription fill limits, prescription drug monitoring programs, mandatory compulsory education and prescriber patterns. H.R 6, SUPPORT for Patients and Communities Act. S. 2680, The Opioid Crisis Response Act of 2018.
Client expense: Not reported · Firm income: $63,750
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Health Issues
Issues related to S.2315 "Over-the-Counter Drug Safety, Innovation, and Reform Act; general issues related to drug pricing;issues related to cosmetic regulations; issues related to insulin pricing;issues related H.R. 6378 "Pandemic and All Hazards Preparedness (PAHPA)Advancing Innovation Act"; issues related to Medicare Part D; issues related to flu and Veterans Affairs; issues related to seasonal influenza vaccination; issues related to 340B Reform; issues related to Drug Importation; issues related to vaccine safety;issues related to HR5333 "Over-the-Counter Monograph Safety, Innovation, and reform Act of 2018; issues related to HR2212 "CREATES Act of 2017";issues related to HR 2439 "Fair Accountability and Innovation Research Drug Act of 2017"; issues related to Medicare rebate disclosure; issues related to S. 2852 "Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018"; issues related to S. 297 "Increasing Competition in Pharmaceuticals Act"; and issues related to S.2465 "Sickle Cell Disease and other Heritable Blood Disorders Research, Surveillance, Prevention and Treatment Act of 2018"
Client expense: $760,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Pharmacy
H.R. 1038/S. 413 - Improving Transparency and Accuracy in Medicare Part D Spending Act H.R.592/S. 109 - Pharmacy and Medically Underserved Areas Enhancement Act H.R. 1316 - Prescription Drug Price Transparency Act H.R. 623 - Fairness to Pet Owners Act Letter to HHS/CMS on direct and indirect remuneration (DIR) fees Discussions with House committees on pharmacy benefit managers (PBMs) H.R.6 - SUPPORT for Patients and Communities Act - FDA Guidelines Section 3004 Letter S. 2680 - Opioid Crisis Response Act of 2018 H.R. 6733, Know the Cost Act of 2018 S. 2553, Know the Lowest Price Act S. 2554, the Patient Right to Know Drug Prices Act H.R. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018
Client expense: $180,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Commerce, Dept of (DOC), Federal Reserve System, HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Lobby members of Congress regarding issues related to telemedicine. Advocate for increased transparency regarding drug pricing. Lobby members of the House to join the Congressional Skin Cancer Caucus. Lobby members of Congress to support H. Res. 282 to encourage proper sun safety practices for youth under care of schools and camps. Advocate for adequate and accurate network coverage for dermatologic care within health insurance exchange networks. Support H.R. 2871, Preserving Patient Access to Compounded Medications Act. Support H.R. 2077, Restoring Patients Voice Act. Support H.R. 1316, Prescription Drug Price Transparency Act. Support H.R. 2051, Fair Access for Safe and Timely Generics Act. Support H.R. 2212/S. 974, Creating and Restoring Equal Access to Equivalent Samples Act. Support H.R. 2999, Patients Access to Treatments Act. Support H.R. 3928, the Truth in Healthcare Marketing Act of 2017. Support S. 637, C-THRU Act. Support S. 989, Ensuring Childrens Access to Specialty Care Act. Support S. 2553, Know the Lowest Prices Act. Support S. 2554, Patient Right to Know Drug Prices Act. Support H.R. 5958, Phair Pricing Act. Support H.R. 5343, Prescription Transparency Act. Support H.R. 6689/S. 3368, Ensuring Lasting Smiles Act. Advocate for relief for from prior authorization requirements under Medicare Advantage and Medicare Part D plans. Support H.R. 4841/H.R. 5773/Section 6062 of H.R. 6 (SUPPORT for Patients & Communities Act), Standardizing Electronic Prior Authorization for Safe Prescribing Act and S. 2908, Electronic Prior Authorization in Medicare Part D Act. Support sunscreen related provisions in S. 2315, OTC Drug Safety, Innovation & Reform Act/H.R. 5333, OTC Monograph Safety, Innovation, & Reform Act. Support pediatric subspecialty loan repayment in any reauthorization of the Title VII programs. Advocate for access to dermatological procedures for veterans through the Veterans Choice Program. Advocate for the continued funding of Community Health Centers. Advocate against including physician advocacy and membership organization in the Physician Payment Sunshine Act requirements as originally included in S. 3000; advocated against inclusion in S. Amendment 4013 to H.R. 6.
Client expense: $500,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Pharmacy
Lobby members of Congress to conduct oversight of implementation of Public Law 113-54, the Drug Quality and Security Act and to protect and preserve the use of compounded pharmaceuticals in the physician office prior to receipt of a patient prescription. Lobby members of Congress to direct the FDA to issue rulemaking pertaining to physicians access to compounded medications for use in the physician office setting. Support H.R. 2871, Preserving Patient Access to Compounded Medications Act. Support H.R. 1316, Prescription Drug Price Transparency Act Support S. 637, C-THRU Act. Support S. 2553, Know the Lowest Price Act. Support S. 2554, Patient Right to Know Drug Prices Act. Support H.R. 5958, Phair Pricing Act. Support H.R. 5343, Prescription Transparency Act. Support sunscreen related provisions in S. 2315, OTC Drug Safety, Innovation & Reform Act/H.R. 5333, OTC Monograph Safety, Innovation, & Reform Act.
Client expense: $500,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2018 · third_quarter · Food Industry (safety, labeling, etc.)
OTC monograph legislation S.2315 Over-the-Counter Drug Safety, Innovation, and Reform Act H.R.5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 Implementation of FSMA Cleaning product labeling
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
- S. 469/H.R. 1245, "Affordable and Safe Prescription Drug Importation Act", regarding all provisions. - S. 771/H.R. 1776, "Improving Access To Affordable Prescription Drugs Act", regarding all provisions. - H.R. 575, "Cosmetic Modernization Amendments of 2017", regarding all provisions. - H.R. 1271, "DXM Abuse Prevention Act of 2017", regarding all provisions. - S. 404/H.R. 1736, "To amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications.", regarding all provisions. - Issues regarding drug pricing. - Issues related to diagnostic reform. - S 260/SJ Res 17/HR 849, Protecting Seniors' Access to Medicare Act of 2017, regarding all provisions - S 251/SJ Res 16, Protecting Medicare from Executive Action Act of 2017, regarding all provisions - S 204/HR 878, Right to Try Act of 2017, regarding all provisions - HR 2026, Pharmaceutical Information Exchange Act, regarding all provisions - HR 1703, Medical Product Communications Act of 2017, regarding all provisions - Issues related to VA procurement of medical devices - HR 2474, Medical Product Review Harmonization Act, regarding all provisions - HR 2144, Risk Based Classification of Accessories Act - Issues related to AMA resolution 208(A-16) regarding attorney ads on drug side effects - S.1113, "Personal Care Products Safety Act", regarding all provisions - HR 2790, "Humane Cosmetics Act", regarding all provisions - HR 3271, "Protecting Access to Diabetes Supplies Act", regarding all provisions - Issues regarding medical device repeal - Issues regarding NIH Funding - HR 2164, "Medical Device Safety Act", regarding all provisions - Issues related to 340B - Issues related to HIV vaccines - S. 2852, "Pandemic & All Hazards Preparedness and Advancing Innovations Act of 2018", regarding all provisions. - Issues related to reauthorization of the Pandemic All-Hazards Preparedness Act programs. (House version) - HR 5492, "MOTHER Act of 2018", regarding all provisions. - Issues related to access to essential surgery - Issues related to contact lens safety - HR 6, "SUPPORT for Patients and Communities Act", regarding all provisions. - S. 2315, "Over-the-Counter Drug Safety, Innovation, and Reform Act", regarding all provisions. - HR 5333 "Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018", regarding all provisions. - Issues related to antimicrobial resistance - Issues related to regulations on medication product packaging - H.R. 6294, " Re-Valuing Anti-Microbial Products Act of 2018", regarding all provisions
Client expense: $1,980,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE, Veterans Affairs, Dept of (VA), White House Office
2018 · third_quarter · Health Issues
Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products. Implementation of the 21st Century Cures Act (P.L.114-255). S.1113, Personal Care Products Safety Act. S.2003, FDA Cosmetic Safety and Modernization Act. S.2315, Over-the-Counter Drug Safety, Innovation, and Reform Act. H.R.5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018. S.2680, Opioid Crisis Response Act of 2018. H.R.6, SUPPORT for Patients and Communities Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
Issues related to Over the Counter (OTC) Monograph reform, influenza, and drug pricing; S.2852, Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018; H.R.6378, To reauthorize certain programs under the Pandemic and All-Hazards Preparedness Reauthorization Act; S.2434/H.R.5554, Animal Drug and Animal Generic Drug User Fee Amendments of 2018 (P.L.115-234); S.2315, Over-the-Counter Drug Safety, Innovation, and Reform Act; H.R.5333, Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · 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. 5333, the Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018 and S. 2315, the Over-the-Counter Drug Safety, Innovation, and Reform Act.
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE