Over-the-Counter Drug Safety, Innovation, and Reform Act

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)

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

Legislative outreach and monitoring related to healthcare issues. S. 2315, Over-the-Counter Drug Safety, Innovation, and Reform Act.

Client expense: Not reported · Firm income: Not reported

Government targets: SENATE

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

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

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

S. 204/H.R. 878 (Trickett Wendler Right to Try Act of 2017); authorizes the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with state law. S. 469/H.R. 1245 (Affordable and Safe Prescription Drug Importation Act); amends the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors. S. 670/H.R. 1652 (Over-the-Counter Hearing Aid Act of 2017); provides for the regulation of over-the-counter hearing aids. S. 297/H.R. 749 (Increasing Competition in Pharmaceuticals Act/Lower Drug Costs through Competition Act); amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs in some circumstances. S. 974/ H.R. 2212 (CREATES Act of 2017); alters the market for drugs and biological products by changing the requirements for generic and biosimilar versions of drugs and biological products. R. 5247 (Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018); with regard to liability issues. S. 2315 (Over-the-Counter Drug Safety, Innovation, and Reform Act); amends the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application. H.R. 5795/ H.R. 6082 (Overdose Prevention and Patient Safety Act); amends the Public Health Service Act to protect the confidentiality of substance use disorder patient records by restricting use of patient records in any civil action. H.R. 5176 (Preventing Overdoses While in Emergency Rooms Act of 2018); requires the Department of Health and Human Services to establish a grant program to: (1) develop protocols for discharging patients who are treated for a drug overdose, and (2) enhance the integration and coordination of postdischarge care and treatment options for individuals with a substance use disorder. H.R. 5197 (ALTO Act); requires and provides funds for, the Department of Health and Human Services to carry out a three-year demonstration program awarding grants to hospitals and emergency departments to develop, implement, enhance, or study alternative pain management protocols and treatments that promote limited use of opioids in emergency departments. H.R. 5009 (Jessie's Law); requires the Department of Health and Human Services (HHS) to develop and disseminate best practices for health care providers and state agencies regarding the display of a patient's history of opioid addiction in the patient's medical records. S. 2981 (Opioid Overdose Reduction Act of 2018); limits an individual's civil liability for harm caused by the emergency administration of an opioid overdose reversal drug (e.g., naloxone). S. 2680 (Opioid Crisis Response Act of 2018); comprehensive bill to address the opioid crisis. S. 2315 (Over-the-Counter Drug Safety, Innovation, and Reform Act); to clarify the regulatory framework with respect to certain nonprescrption drugs that are marketed without an approved new drug application. General lobbying with regard to the federal preemption of state causes of action involving medical device and drug manufacturers. General lobbying with regard to off label promotion of pharmaceutical products. General lobbying with regard to pharmaceutical drug advertising. General lobbying with regard to pharmaceutical price-gouging. General lobbying with regard to biosimilar naming and labeling. General lobbying with regard to updating generic drug labeling responsibilities. General lobbying with regard to opioid manufacturer liability. General lobbying with regard to opioid superfund and Medicare Secondary Payer issues. General lobbying with regard to OTC monograph federal preemption issues.

Client expense: $1,300,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)

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

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

- 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

FDA regulation of cosmetics and Consumer Product Safety issues. Monitor data breach notification, cyber security and digital privacy proposals. S. 1113 - Personal Care Products Safety Act. S. 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act.

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)

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)

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

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

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

PL 114-255 - 21st Century Cures, implementation H.R. 878/S. 204 - Right to Try Act H.R. 1231/S. 456 - RACE for Children Act H.R. 2430 - FDA Reauthorization Act of 2017 H.R. 849/S. 260 - Protecting Seniors' Access to Medicare Act S. 2852 - Pandemic and All Hazards Preparedness Act S.2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act H.R. 6 - SUPPORT for Patients and Communities Act ***no specific bills, importation, supply chain integrity, 304b, biosimilars, orphan drugs, newborn screening, expanded access, priority review, transparency, drug shortages, IPAB

Client expense: Not reported · Firm income: $60,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Veterans Affairs, Dept of (VA)

Education and importance of various pharmaceutical industry issues, including issues affecting vaccines; emerging infectious diseases within S.2852, the Pandemic and All-Hazards Preparedness and Advancing Innovation Act; and over-the-counter monograph reform in S.2315, the Over-the-Counter Drug Safety Innovation and Reform Act.

Client expense: Not reported · Firm income: $40,000

Government targets: SENATE

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)

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

H.R.6261 - Improving Choices in Health Care Coverage Act S.3095 - Building a Health Care Workforce for the Future Act H.R.6128 - HSA Employer Flexibility Act H.R.6110 - Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018 H.R.6098 - Family Medical Leave Modernization Act H.R.6097 - State-Based Universal Health Care Act of 2018 H.R.6082 - Overdose Prevention and Patient Safety Act H.R.6 - SUPPORT for Patients and Communities Act S.3063 - Health Insurance Tax Relief Act of 2018 H.R.6071 - SERV Communities Act S.3053 - CHIP Mental Health and Addiction Parity Act S.3048 - Examining Opioid Treatment Infrastructure Act of 2018 H.R.6050 - Increasing Access to Care Act S.3016 - Action for Dental Health Act of 2018 S.3000 - Patient Advocacy Transparency Act H.R.5997 - Ensuring Patient Access to Critical Breakthrough Products Act of 2018 H.Res.915 - Expressing the sense of the Congress in support of protecting patients' access to medically appropriate, evidence-based healthcare and information, and the ethical and professional obligations of healthcare professionals to provide that care and information H.R.5966 - Women Veterans Access to Quality Care Act of 2018 H.R.5965 - Access to Infertility Treatment and Care Act H.R.5963 - To delay the reimposition of the annual fee on health insurance providers until after 2020 S.2960 - Access to Infertility Treatment and Care Act S.Res.526 - A resolution expressing the sense of the Senate that politicians should not interfere with a woman's personal health care decisions or attempt to prevent providers from offering their full medical recommendations to their patients H.R.5942 - Health Equity and Accountability Act of 2018 H.R.5933 - Substance Abuse Prevention Act of 2018 H.R.5932 - Increasing Access to Mental Health in Schools Act H.R.5925 - CRISIS Act S.2934 - Increasing Access to Mental Health in Schools Act H.R.5917 - Professional's Access to Health Workforce Integration Act of 2018 H.R.5914 - To require a study and report on policy and regulatory changes that may have contributed to the opioid epidemic S.2920 - Commit to Opioid Medical Prescriber Accountability and Safety for Seniors Act of 2018 S.2912 - Opioid Addiction Treatment Programs Enhancement Act H.R.6144 - Know the Lowest Price Act of 2018 S.204 - Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 S.2680 - Opioid Crisis Response Act of 2018 H.R.5511 - Healthy Communities Act of 2018 H.R.5491 - Rural Health Insurance Act of 2018 H.R.5455 - Accelerating Biomedical Research Act H.R.5641 - State Offices of Rural Health Reauthorization Act of 2018 H.R.5625 - Easy Enrollment Act of 2018 H.R.5624 - Pathway to Universal Coverage Act of 2018 H.R.5603 - Access to Telehealth Services for Substance Use Disorders Act S.2732 - Defending Access to Mental Health Care Act H.R.5699 - HOST Act of 2018 S.2802 - Responsible Additions and Increases to Sustain Employee Health Benefits Act of 2018 H.R.5725 - BEST Act S.2902 - Better Data Sharing to Combat the Opioid Crisis Act S.2901 - eTREAT Act H.R.5892 - To establish an Advisory Committee on Opioids and the Workplace to advise the Secretary of Labor on actions the Department of Labor can take to address the impact of opioid abuse on the workplace H.R.5858 - Primary Care Patient Protection Act of 2018 S.2875 - COMBAT Act of 2018 H.R.5795 - Overdose Prevention and Patient Safety Act S.2851 - Regional Health Care Emergency Preparedness and Response Systems Act H.R.5775 - Providing Reliable Options for Patients and Educational Resources Act of 2018 H.R.5769 - Expanding Access to Treatment Act S. 2608 - Reducing Opioid Risk Act S. 2589 - Comprehensive Opioid Recovery Centers Act of 2018 S. 2582 - Consumer Health Insurance Protection Act of 2018 S. 2554 - Patient Right to Know Drug Prices Act H.R. 5258 - Affordable Health Insurance for the Middle Class Act H.R. 5254 - To direct the Secretary of HHS to conduct a study on the feasibility of expanding eligibility for enrollment in Medicare Advantage plans to individuals enrolled under the Medicaid program or enrolled under a group health plan H.R. 5223 - Health Care Workplace Violence Prevention Act S. 2507 - Improving Choice in Health Care Coverage Act H.R. 5155 - Undo Sabotage and Expand Affordability of Health Insurance Act of 2018 S. 2496 - Small Business Health Account Act of 2018 S. 2494 - Fair Care Act H.R. 5138 - Bipartisan HSA Improvement Act of 2018 H.R. 5124 - Community Action Opioid Response Act of 2018 H.R. 5097 - PAVE Act of 2018 H.R. 5080 - COMBAT Act of 2018 H.R. 5062 - Advancing Access to Precision Medicine Act H.R. 5047 - VA Community Care Enhancement Act S. 2437 - Opioid Response Enhancement Act S. 2415 - Accelerating Kids Access to Care Act H.R. 4978 - Chronic Disease Management Act of 2018 S. 2410 - Chronic Disease Management Act of 2018 H.R. 4952 - To direct the Secretary of HHS to conduct a study and submit a report on the effects of the inclusion of quality increases in the determination of blended benchmark amounts under part C of the Medicare program H.R. 4938 - Respond NOW Act H.R. 4894 - Harmful Tax Prevention Act H.R. 4841 - Standardizing Electronic Prior Authorization for Safe Prescribing Act of 2018 H.R. 4831 - Healthcare Tax Relief Act H.R. 4820 - ASK Act S. 2315 - Over-the-Counter Drug Safety, Innovation, and Reform Act H.R. 4808 - Transparent Health Care Pricing Act of 2018 S. 2312 - HELP Act H.R. 4784 - ACA OUTREACH Act H.R. 4778 - Behavioral Health Coverage Transparency Act of 2018 S. 2302 - Access to Independent Health Insurance Advisors Act of 2018 S. 2301 - Behavioral Health Coverage Transparency Act of 2018 H.R. 4575 - A bill to amend title XXVII of the Public Health Service Act to preserve consumer and employer access to licensed independent insurance producers. S. 2303 - A bill to amend title XXVII of the Public Health Service Act to preserve consumer and employer access to licensed independent insurance producers. H.R. 1625 - Consolidated Appropriations Act, 2018 S. 2553 - Know the Lowest Price Act of 2018 H.R. 5343 - Prescription Transparency Act of 2018 H.R. 5150 - Protecting Medicare from Excessive Price Increases Act of 2018 H.R. 4874 - End The Shutdown Act of 2018 H.R. 4872 - End The Shutdown Act of 2018 H.R. 5104 - A bill to amend title XVIII of the Social Security Act to provide for a special enrollment period under Medicare for individuals enrolled in COBRA continuation coverage, and for other purposes H.R. 6 - SUPPORT for Patients and Communities Act S. 2554 - Patient Right to Know Drug Prices Act S. 2553 - Know the Lowest Price Act of 2018 H.R. 302 - FAA Re authorization Act of 2018 H. R. 6662 - Empowering Seniors Enrollment Decision Act of 2018 H.R. 6305 - Bipartisan HSA Improvement Act of 2018 H.R. 6312 - Personal Health Investment Today (PHIT) Act H.R. 6309 - To amend the Internal Revenue Code of 1986 to allow individuals entitled to Medicare Part A by reason of being over age 65 to contribute to health savings accounts H.R. 4616 - To amend the Patient Protection and Affordable Care Act to provide for a temporary moratorium on the employer mandate and to provide for a delay in the implementation of the excise tax on high cost employer-sponsored health coverage H.R. 6311 - To amend the Internal Revenue Code of 1986 and the Patient Protection and Affordable Care Act to modify the definition of qualified health plan for purposes of the health insurance premium tax credit and to allow individuals purchasing health insurance in the individual market to purchase a lower premium copper plan

Client expense: $330,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Internal Revenue Service (IRS), Labor, Dept of (DOL), SENATE, Treasury, Dept of, White House Office

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

General education about federal policies impacting pharmaceutical development, approval, and reimbursement (including Medicare, Medicaid, Affordable Care Act issues). Policies impacting public health preparedness and prevention. Pandemic All Hazards Preparedness Authorization Act of 2018, H.R. 6378, S. 2851, H.R. 7328, S. 2852. Over-the-Counter Drug Safety Innovations and Reform Act, S. 2315, H.R. 7328. H.R. 6 Support for Patients and Communities Act.

Client expense: Not reported · Firm income: $60,000

Government targets: HOUSE OF REPRESENTATIVES, SENATE

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

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

H.R. 7328 - Pandemic and All Hazards Preparedness and Advancing Innovation (PAHPAI) Act of 2018 - SUpport of PAHPA reauthorization and OTC monograph reform. H.R. 6 - Support for Patients and Communities Act - Support for policies that help to fight the opioid epidemic with a focus on public health. S. 3120 - Helping to End Addiction and Lessen Substance Use Disorders Act - Support for policies that help to fight the opioid epidemic with a focus on public health. S. 2315 - The Over the Counter Drug Safety Innovation and Reform Act - Support for amending and improving OTC Monograph Reform. S. 2852 - the Pandemic and All Hazards Preparedness and Advancing Innovation Act of 2018 - Issues related to the continues attention required to antibiotic resistance as a public health threat and policies to ensure the adequacy and development of antibiotics to ward against threats to the common good. Trump Administration's Blueprint for lowering the price of prescription medications in the United States. CMS regulations related to Medicare Part D and promulgation of laws related to curbing substance use disorder among Medicare beneficiaries. H.R. 2871 - The Preserving Patient Access to Compounded Medications Act of 2017 - Concerns about how the bill could compromise safety protocols for compounded medications. Issues related to antibiotic innovation and advancement Issues related to health information technology, unique device identifiers on Medicare claims forms, and other critical policies to promote device safety. Issues related to over the counter medications and supplements. Issues related to HIT needs and capabilities within the Veteran's health care system.

Client expense: Not reported · Firm income: $30,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

H.R. 6 - Support for Patients and Communities Act - Support for policies that help to fight the opioid epidemic with a focus on public health. S. 3120 - Helping to End Addiction and Lessen Substance Use Disorders Act - Support for policies that help to fight the opioid epidemic with a focus on public health. S. 2315 - The Over the Counter Drug Safety Innovation and Reform Act - Support for amending and improving OTC Monograph Reform. S. 2852 - the Pandemic and All Hazards Preparedness and Advancing Innovation Act of 2018 - Issues related to the continues attention required to antibiotic resistance as a public health threat and policies to ensure the adequacy and development of antibiotics to ward against threats to the common good. Trump Administration's Blueprint for lowering the price of prescription medications in the United States. CMS regulations related to Medicare Part D and promulgation of laws related to curbing substance use disorder among Medicare beneficiaries. H.R. 2871 - The Preserving Patient Access to Compounded Medications Act of 2017 - Concerns about how the bill could compromise safety protocols for compounded medications. Issues related to antibiotic innovation and advancement Issues related to over the counter medications and supplements.

Client expense: Not reported · Firm income: $30,000

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

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

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

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

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

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

S. 204/H.R. 878 (Trickett Wendler Right to Try Act of 2017); authorizes the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with State law. S. 469/H.R. 1245 (Affordable and Safe Prescription Drug Importation Act); amends the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors. S. 670/H.R. 1652 (Over-the-Counter Hearing Aid Act of 2017); provides for the regulation of over-the-counter hearing aids. S. 297/H.R. 749 (Increasing Competition in Pharmaceuticals Act/Lower Drug Costs through Competition Act); amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs in some circumstances. S. 974 (CREATES Act of 2017); alters the market for drugs and biological products by changing the requirements for generic and biosimilar versions of drugs and biological products. R. 5247 (Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018); with regard to liability issues. S. 2315 (Over-the-Counter Drug Safety, Innovation, and Reform Act); amends the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application. H.R. 5795/ H.R. 6082 (Overdose Prevention and Patient Safety Act); amends the Public Health Service Act to protect the confidentiality of substance use disorder patient records by restricting use of patient records in any civil action. H.R. 5176 (Preventing Overdoses While in Emergency Rooms Act of 2018); requires the Department of Health and Human Services to establish a grant program to: (1) develop protocols for discharging patients who are treated for a drug overdose, and (2) enhance the integration and coordination of postdischarge care and treatment options for individuals with a substance use disorder. H.R. 5197 (ALTO Act); requires and provides funds for, the Department of Health and Human Services to carry out a three-year demonstration program awarding grants to hospitals and emergency departments to develop, implement, enhance, or study alternative pain management protocols and treatments that promote limited use of opioids in emergency departments. H.R. 5009 (Jessie's Law); requires the Department of Health and Human Services (HHS) to develop and disseminate best practices for health care providers and state agencies regarding the display of a patient's history of opioid addiction in the patient's medical records. S. 2981 (Opioid Overdose Reduction Act of 2018); limits an individual's civil liability for harm caused by the emergency administration of an opioid overdose reversal drug (e.g., naloxone). S. 2680 (Opioid Crisis Response Act of 2018); comprehensive bill to address the opioid crisis. General lobbying with regard to the preemption of states causes of action involving medical device and drug manufacturers. General lobbying with regard to off label promotion of pharmaceutical products. General lobbying with regard to pharmaceutical drug advertising. General lobbying with regard to pharmaceutical price-gouging. General lobbying with regard to biosimilar naming and labeling. General lobbying with regard to updating generic drug labeling responsibilities. General lobbying with regard to opioid manufacturer liability. General lobbying with regard to opioid superfund and Medicare Secondary Payer issues. General lobbying with regard to OTC monograph preemption issues.

Client expense: $1,430,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE

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

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

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

- 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)

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

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

S. 204/H.R. 878 (Trickett Wendler Right to Try Act of 2017); authorizes the use of unapproved medical products by patients diagnosed with a terminal illness in accordance with state law. S. 469/H.R. 1245 (Affordable and Safe Prescription Drug Importation Act); amends the Federal Food, Drug, and Cosmetic Act to allow for the importation of affordable and safe drugs by wholesale distributors. S. 670/H.R. 1652 (Over-the-Counter Hearing Aid Act of 2017); provides for the regulation of over-the-counter hearing aids. S. 297/H.R. 749 (Increasing Competition in Pharmaceuticals Act/Lower Drug Costs through Competition Act); amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs in some circumstances. S. 974 (CREATES Act of 2017); alters the market for drugs and biological products by changing the requirements for generic and biosimilar versions of drugs and biological products. R. 5247 (Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018); with regard to liability issues. S. 2315 (Over-the-Counter Drug Safety, Innovation, and Reform Act); amends the Federal Food, Drug, and Cosmetic Act to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved new drug application. H.R. 5795/ H.R. 6082 (Overdose Prevention and Patient Safety Act); amends the Public Health Service Act to protect the confidentiality of substance use disorder patient records by restricting use of patient records in any civil action. H.R. 5176 (Preventing Overdoses While in Emergency Rooms Act of 2018); requires the Department of Health and Human Services to establish a grant program to: (1) develop protocols for discharging patients who are treated for a drug overdose, and (2) enhance the integration and coordination of postdischarge care and treatment options for individuals with a substance use disorder. H.R. 5197 (ALTO Act); requires and provides funds for, the Department of Health and Human Services to carry out a three-year demonstration program awarding grants to hospitals and emergency departments to develop, implement, enhance, or study alternative pain management protocols and treatments that promote limited use of opioids in emergency departments. H.R. 5009 (Jessie's Law); requires the Department of Health and Human Services (HHS) to develop and disseminate best practices for health care providers and state agencies regarding the display of a patient's history of opioid addiction in the patient's medical records. S. 2981 (Opioid Overdose Reduction Act of 2018); limits an individual's civil liability for harm caused by the emergency administration of an opioid overdose reversal drug (e.g., naloxone). S. 2680 (Opioid Crisis Response Act of 2018); comprehensive bill to address the opioid crisis. General lobbying with regard to the federal preemption of state causes of action involving medical device and drug manufacturers. General lobbying with regard to off label promotion of pharmaceutical products. General lobbying with regard to pharmaceutical drug advertising. General lobbying with regard to pharmaceutical price-gouging. General lobbying with regard to biosimilar naming and labeling. General lobbying with regard to updating generic drug labeling responsibilities. General lobbying with regard to opioid manufacturer liability. General lobbying with regard to opioid superfund and Medicare Secondary Payer issues. General lobbying with regard to OTC monograph federal preemption issues.

Client expense: $1,510,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE, Securities & Exchange Commission (SEC)

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

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

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

- 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

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

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