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Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017
Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
37pct
1d open
vs 7,393 other HR bills in the 115th — cohort avg 50d
Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 This bill amends the Federal Food, Drug, and Cosmetic Act to prevent an application for a new drug from being considered ineligible for approval because its labeling includes information describing abuse-deterrent properties that otherwise would be blocked by market exclusivity provisions. The Department of Health and Human Services shall issue draft guidance and publish final guidance regarding the award and scope of exclusivity for new drugs with properties designed to deter abuse and the exceptions to such exclusivity. The bill applies to applications and supplements to applications that are submitted or pending approval on or after January 1, 2017.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (9)
Referred to the Subcommittee on Health.
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
Bills with similar content found using semantic analysis.
Sources: Congress.gov
2018 · fourth_quarter · Pharmacy
Design and coverage of pharmacy benefits in Exchanges and the commercial market, including: eRx, EPCS, electronic prior authorization, PBM disclosure, MLR, and specialty pharmacy tiering. Implementation of biosimilars pathway from BPCIA. Policies placing restrictions on pharmacy benefit design. Issues relating to prescription drug affordability. REMS reform. Prescription drug user fee reauthorization. HR 1854; S 788; HR 2025; S 2553 and S 2554; HR 6.
Client expense: $840,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Personnel Management (OPM), SENATE, White House Office
2018 · fourth_quarter · Copyright/Patent/Trademark
H.R. 2025, the Abuse Deterrent Opioids Plan for Tomorrow.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
H.R. 2025, the Abuse Deterrent Opioids Plan for Tomorrow.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · fourth_quarter · Health Issues
HR 2025, Abuse-Deterrent Opioids Plan for Tomorrow Act; and FDA regulatory issues.
Client expense: Not reported · Firm income: $45,000
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 · Copyright/Patent/Trademark
H.R. 2025, the Abuse Deterrent Opioids Plan for Tomorrow.
Client expense: Not reported · Firm income: $20,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · third_quarter · Health Issues
H.R. 2025, the Abuse Deterrent Opioids Plan for Tomorrow.
Client expense: Not reported · Firm income: $20,000
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. 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. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder records H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2018 - Provisions related to substance use disorder information 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. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to loan repayment program 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. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding 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. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States 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. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements 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. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 3428: Lessening Addiction by Enhancing Labeling Opiods Act of 2018 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)
2018 · third_quarter · Pharmacy
Design and coverage of pharmacy benefits in Exchanges and the commercial market, including: eRx, EPCS, electronic prior authorization, PBM disclosure, MLR, and specialty pharmacy tiering. Implementation of biosimilars pathway from BPCIA. Policies placing restrictions on pharmacy benefit design. Issues relating to prescription drug affordability. REMS reform. Prescription drug user fee reauthorization. HR 1854; S. 788; HR 2025; S. 2553 and S. 2554; HR 6.
Client expense: $760,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Personnel Management (OPM), SENATE, White House Office
2018 · third_quarter · Health Issues
HR 2025, Abuse-Deterrent Opioids Plan for Tomorrow Act; and FDA regulatory issues.
Client expense: Not reported · Firm income: $45,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Health Issues
H.R. 2025, the Abuse Deterrent Opioids Plan for Tomorrow.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_quarter · Copyright/Patent/Trademark
H.R. 2025, the Abuse Deterrent Opioids Plan for Tomorrow.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · second_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. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications 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. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to controlled substances H.R. 3528: Every Prescription Conveyed Securely Act - e-Prescribing for coverage under part D of the Medicare program of prescription drugs that are controlled substances H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection 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. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers H.R. 5150: Protecting Medicare from Excessive Price Increases Act of 2018 - To require drug manufacturers to pay a Medicare part B rebate for certain drugs H.R. 5151: To amend the Public Health Service Act to reauthorize a grant program improving treatment for pregnant and postpartum women 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. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. 5477: Rural DOCS Act - To provide for a demonstration project to increase substance use provider capacity under the Medicaid program H.R. 5580: STOP Fentanyl Deaths Act of 2018 - To authorize the Secretary of Health and Human Services to conduct programs to address the usage of illicit drugs, particularly fentanyl H.R. 5598: 340B Optimization Act - Provisions related to transparency in the 340B program H.R. 5676: Stop Excessive Narcotics in our Retirement Communities Protection Act of 2018 - To authorize the suspension of payments by Medicare prescription drug plans and MA-PD plans pending investigations of credible allegations of fraud by pharmacies H.R. 5687: SOUND Disposal and Packaging Act - Provisions related to packaging and disposal methods with respect to certain drugs H.R. 5711: Improving Access to Mental Health Services Act - To allow National Health Service Corps members to provide obligated service as behavioral and mental health professionals at schools, other community-based settings, or patient homes H.R. 5723: Expanding Oversight of Opioid Prescribing and Payment Act of 2018 - To require the Medicare Payment Advisory Commission to report on opioid payment, adverse incentives, and data under the Medicare program H.R. 5752: Stop Illicit Importation Act of 2018 - Provisions related to importation H.R. 5762: Joint Task Force to Combat Opioid Trafficking Act of 2018 - To authorize a Joint Task Force to enhance integration of the Department of Homeland Securitys border security operations to detect, interdict, disrupt, and prevent narcotics, such as fentanyl and other synthetic opioids, from entering the United States H.R. 5774: Combating Opioid Abuse for Care in Hospitals Act of 2018 - Provisions related to opioids H.R. 5775: Providing Reliable Options for Patients and Educational Resources Act of 2018 - To require Medicare Advantage plans and part D prescription drug plans to include information on the risks associated with opioids, coverage of certain nonopioid treatments used to treat pain, and on the safe disposal of prescription drugs H.R. 5796: Responsible Education Achieves Care and Healthy Outcomes for Users' Treatment (REACH OUT) Act of 2018 - To require the Secretary of Health and Human Services to provide grants for eligible entities to provide technical assistance to outlier prescribers of opioids H.R. 5803: SAFETY Act of 2018 - Provisions related to drug approval H.R. 5811: Long-Term Opioid Efficacy Act of 2018 - Postapproval study requirements H.R. 6071: SERV Communities Act - Provisions related to transparency in the 340B program H.R. 6110: Dr. Todd Graham Pain Management, Treatment, and Recovery Act of 2018' H.R. 6142: Reducing Drug Waste Act of 2018 - Action plan and report on vial size waste S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness 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. 2312: HELP Act - Provisions related to 340B program S. 2406: ACE Research Act - Research initiatives of the NIH 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 - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding 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. 2680: Opioid Crisis Response Act of 2018 - Provisions related to opioids S. 2842: Opioid Addiction Recovery Fraud Prevention Act of 2018 - Provisions related to opioid treatment programs or products S. __: Drug Accepted Use Labeling Act of 2018 - Provisions related to 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 Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy 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 Opioids 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)
2018 · second_quarter · Pharmacy
Design and coverage of pharmacy benefits in Exchanges and the commercial market, including: eRx, EPCS, electronic prior authorization, PBM disclosure, MLR, and specialty pharmacy tiering. Implementation of biosimilars pathway from BPCIA. Policies placing restrictions on pharmacy benefit design. Issues relating to prescription drug affordability. REMS reform. Prescription drug user fee reauthorization. HR 1854; S. 788; HR 2025; S. 2553 and S. 2554.
Client expense: $815,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Personnel Management (OPM), SENATE, White House Office
2018 · second_quarter · Health Issues
HR 2025, Abuse-Deterrent Opioids Plan for Tomorrow Act; and FDA regulatory issues.
Client expense: Not reported · Firm income: $45,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Health Issues
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. 1231: RACE for Children Act - Provisions related to pediatric studies 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. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs 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. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications 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. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to drug rescheduling H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication-assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection 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.4297 - Protecting Seniors Through Immunization Act HR4993, Vaccine Access Improvement Act, Technical fix to efficiently add new vaccines to VICPHR4297/S2103, Protecting Seniors through Immunization Act, HR 1625 - Consolidated Appropriatons Act of 2018 - Part D Doughnut HoleHR 1625 - Consolidated Approriations Act of 2018 - Ryan White and ADAP FundingHR 1892 - Further Extension of Continuing Appropriations Act, 2018 - Part D Doughnut Hole HR 5333 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2018S 2315 - Over-the-Counter Drug Safety, Innovation, and Reform ActHR 4710 - 340B PAUSE ActS 2312 - HELP Act340B Drug Discount ProgramMedicare Part D - Doughnut Hole; Non-Interference ClauseFY19 Appropriations - DoD - Oral HealthFY19 Appropriations - HHS - Ryan White Program/ADAPHR 394 - Restoring Access to Medication ActS 85 - Restoring Access to Medication Act of 2017HR 4618 - To amend the Internal Revenue Code of 1986 to provide for a temporary moratorium on certain taxes affecting purchases of prescription medication. Medicaid - access for chronic care patients Prescription Drug PricingS469 - Affordable and Safe Prescription Drug Importation Act HR 1245 - Affordable and Safe Prescription Drug Importation Act Drug Importation HR 242 - Medicare Prescription Drug Price Negotiation Act of 2017Draft legislation on opioids - FDA packaging and disposal Draft legislation on opioids - Tableting and Encapsulating Machine Regulation Act of 2018 H.R. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers 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. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. __: FDA and International Mail - Provisions related to chemical importation H.R. __: FDA Long-term Efficacy - Provisions related to post-approval studies H.R. __: FDA Misuse/Abuse - Provisions related to misuse/abuse in approval decisions H.R. __: FDA Packaging and Disposal - Provisions related to drug packaging H.R. __: Tableting and Encapsulating Machine Regulation Act of 2018 - Provisions related to manufacturing equipment H.R. __: The Special Registration for Telemedicine Clarification Act of 2018 - Provisions related to telemedicine H.R. __: The Improving Access to Remote Behavioral Health Treatment Act of 2018 - Provisions related to telemedicine H.R. __: A Bill to Improve Fentanyl Testing and Surveillance - Provisions related to synthetic opioid detection grants H.R. __: A Bill to Enhance and Improve State-run Prescription Drug Monitoring Programs - Provisions related to evidence-based overdose prevention grants and other funding H.R. __: A Bill to Support the Peer Support Specialist Workforce - Provisions related to national youth recovery grants and other funding H.R. __: FDA Accelerated Approval and Breakthrough Therapy Status - Provisions related to expedited treatment for non-opioid medicines H.R. __: FDA Opioid Sparing - Provisions related to alternative models for data collection S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness 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. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals 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. 2456: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding S. __: Access to Increased Drug Disposal Act of 2018 - Provisions related to grants for disposal Biopharmaceutical innovation policy issues Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues National All Schedules Prescription Electronic Reporting Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Clinical trial 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 Confirmation of Alex Azar Opioids shortages policy issues
2018 · first_quarter · Pharmacy
Design and coverage of pharmacy benefits in Exchanges and the commercial market, including: EHB, grandfathering, Rx quality, eRx, EPCS, electronic prior authorization, PBM disclosure, MLR, and specialty pharmacy tiering. Implementation of biosimilars pathway from BPCIA. Policies placing restrictions on pharmacy benefit design. Issues relating to prescription drug affordability. REMS reform. Prescription drug user fee reauthorization. HR 1854; S. 788; HR 2025.
Client expense: $820,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Personnel Management (OPM), SENATE, White House Office
2018 · first_quarter · Health Issues
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. 1231: RACE for Children Act - Provisions related to pediatric studies 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. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs 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. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications 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. 2851: Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act - Provisions related to drug rescheduling H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 3545: Overdose Prevention and Patient Safety Act - Provisions related to substance use disorder information sharing H.R. 3692: Addiction Treatment Access Improvement Act of 2017 - Provisions related to medication-assisted treatment (MAT) access H.R. 4275: Empowering Pharmacists in the Fight Against Opioid Abuse Act - Provisions related to pharmacist education H.R. 4284: Indexing Narcotics, Fentanyl, and Opioids (INFO) Act of 2017 - Provisions related to substance data collection 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. 5002: Advancing Cutting Edge Research Act - Provisions related to non-addiction pain medication H.R. 5009: Jessies Law - Provisions related to patient information sharing H.R. 5041: The Safe Disposal of Unused Medication Act - Provisions related to drug disposal H.R. 5102: Substance Use Disorder Workforce Loan Repayment Act of 2018 - Provisions related to student loan repayment to substance use disorder (SUD) providers 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. 5247: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018 - Provisions related to use of unapproved medical products by patients with a terminal illness H.R. 5261: Treatment, Education, and Community Help to Combat Addiction Act of 2018 - Provisions related to grants for substance use disorder (SUD) prevention, treatment, and recovery H.R. 5311: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act H.R. 5327: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to opioid recovery center grants H.R. 5329: Poison Center Network Enhancement Act of 2018 - Provisions related to national poison center funding and other prevention funding H.R. 5353: Eliminating Opioid Related Infectious Diseases Act of 2018 - Provisions related to CDC infection surveillance and other funding H.R. __: FDA and International Mail - Provisions related to chemical importation H.R. __: FDA Long-term Efficacy - Provisions related to post-approval studies H.R. __: FDA Misuse/Abuse - Provisions related to misuse/abuse in approval decisions H.R. __: FDA Packaging and Disposal - Provisions related to drug packaging H.R. __: Tableting and Encapsulating Machine Regulation Act of 2018 - Provisions related to manufacturing equipment H.R. __: The Special Registration for Telemedicine Clarification Act of 2018 - Provisions related to telemedicine H.R. __: The Improving Access to Remote Behavioral Health Treatment Act of 2018 - Provisions related to telemedicine H.R. __: A Bill to Improve Fentanyl Testing and Surveillance - Provisions related to synthetic opioid detection grants H.R. __: A Bill to Enhance and Improve State-run Prescription Drug Monitoring Programs - Provisions related to evidence-based overdose prevention grants and other funding H.R. __: A Bill to Support the Peer Support Specialist Workforce - Provisions related to national youth recovery grants and other funding H.R. __: FDA Accelerated Approval and Breakthrough Therapy Status - Provisions related to expedited treatment for non-opioid medicines H.R. __: FDA Opioid Sparing - Provisions related to alternative models for data collection S. 204: Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness 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. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals 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. 2456: CARA 2.0 Act of 2018 - Provisions to reauthorize and expand the Comprehensive Addiction and Recovery Act S. 2553: Know the Lowest Price Act of 2018 - Provisions related to drug pricing S. 2554: Patient Right to Know Drug Prices Act - Provisions related to drug pricing S. 2589: Comprehensive Opioid Recovery Centers Act of 2018 - Provisions related to CDC infection surveillance and other funding S. __: Access to Increased Drug Disposal Act of 2018 - Provisions related to grants for disposal Biopharmaceutical innovation policy issues Drug cost and pricing policy issues Transparency policy issues Drug importation and counterfeiting policy issues Prescription drug take back and secure disposal policy issues National All Schedules Prescription Electronic Reporting Policy issues related to prescription drug abuse and opioids Expanded access policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development of FDA policy Patient assistance program policy issues Clinical trial 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 Confirmation of Alex Azar Opioids shortages policy issues
2018 · first_quarter · Copyright/Patent/Trademark
H.R. 2025, the Abuse Deterrent Opioids Plan for Tomorrow.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Health Issues
H.R. 2025, the Abuse Deterrent Opioids Plan for Tomorrow.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2018 · first_quarter · Health Issues
HR 2025, Abuse-Deterrent Opioids Plan for Tomorrow Act; and FDA regulatory issues.
Client expense: Not reported · Firm income: $45,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · fourth_quarter · Health Issues
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. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies 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. 892: Opioid Addiction Prevention Act of 2017 - Scheduling issues 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 H.R. 1: Tax Cuts and Jobs Act - An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 (Public Law 115-97) 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. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies 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. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Scheduling issues H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 4710: 340B Protecting Access for the Underserved and Safety-Net Entities Act or PAUSE Act - 340B program Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) 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 Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Clinical trial policy issues Cancer drug vial size policy issues A Better Deal economic platform proposal - Provisions related to drug cost and pricing policy issues TRICARE pharmacy pilot program Confirmation of Alex Azar HR 4710 - 340B PAUSE ActHR 4297 - Protecting Seniors Through Immunization Act of 2017H.J.Res. 123 - Making further continuing appropriations for fiscal year 2018, and for other purposes.Graham-Cassidy Health Care Bill (S. Amdt. 1030 to HR 1628, the American Health Care Act of 2017)HR 4297/S. 2103 - Protecting Seniors Through Immunization Act of 2017Monograph Reform House and Senate Continuing Resolution IPAB Legislation-House 340B Tax Reform
2017 · fourth_quarter · Health Issues
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. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies 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. 892: Opioid Addiction Prevention Act of 2017 - Scheduling issues 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 H.R. 1: Tax Cuts and Jobs Act - An Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 (Public Law 115-97) 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. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies 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. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Scheduling issues H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding H.R. 4710: 340B Protecting Access for the Underserved and Safety-Net Entities Act or PAUSE Act - 340B program Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) Ensuring Patient Access and Effective Drug Enforcement Act of 2016 (Public Law No. 114-145) 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 Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Clinical trial policy issues Cancer drug vial size policy issues A Better Deal economic platform proposal - Provisions related to drug cost and pricing policy issues Confirmation of Alex Azar TRICARE pharmacy pilot program
2017 · fourth_quarter · Pharmacy
Design and coverage of pharmacy benefits in Exchanges and the commercial market, including: EHB, grandfathering, Rx quality, eRx, EPCS, electronic prior authorization, PBM disclosure, MLR, and specialty pharmacy tiering. Implementation of biosimilars pathway from BPCIA. Policies placing restrictions on pharmacy benefit design. Issues relating to prescription drug affordability. REMS reform. Prescription drug user fee reauthorization. HR 1854; S. 788; HR 2025.
Client expense: $830,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Personnel Management (OPM), SENATE, White House Office
2017 · fourth_quarter · Copyright/Patent/Trademark
H.R. 2025, the Abuse Deterrent Opioids Plan for Tomorrow.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · fourth_quarter · Health Issues
H.R. 2025, the Abuse Deterrent Opioids Plan for Tomorrow.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · fourth_quarter · Pharmacy
H.R.2025, Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 Discussions regarding opioid abuse Discussions regarding 340B drug discount program
Client expense: $190,000 · Firm income: Not reported
2017 · fourth_quarter · Health Issues
HR 2025, Abuse-Deterrent Opioids Plan for Tomorrow Act; and FDA regulatory issues.
Client expense: Not reported · Firm income: $45,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · third_quarter · Health Issues
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. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies 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. 934: FDA Reauthorization Act of 2017 - Provisions related to user fee program 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 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. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies 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. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs 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. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2430: FDA Reauthorization Act of 2017 - Provisions related to user fee programsFSAs/HSAsMonograph ReformOver-the-Counter Monograph Safety, Innovation, and Reform Act of 2017Cosmetics Regulatory Reform at FDATax ReformLow Income Subsidy (LIS) Payments within Medicare Part DDirect and Indirect Remuneration (DIR) Payments within Medicare Part D,Independent Payment Advisory Board (IPAB) RepealChildren's Health Insurance Program (CHIP) Reauthorization H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Provisions related to amending the Controlled Substances Act to give DEA greater authority to schedule certain synthetic drugs H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) 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 Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Proposed Rule delaying the effective date of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; RIN 0906-AB11 (82 Fed. Reg. 39553 (August 21, 2017)) Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Clinical trial policy issues Cancer drug vial size policy issues A Better Deal economic platform proposal - Provisions related to drug cost and pricing policy issues TRICARE pharmacy pilot program HR 3358 - Labor, HHS, Education and Related Agencies Appropriations Act of 2018 S 1771 - Labor, HHS, Education and Related Agencies Appropriations Act of 2018 HR 3921 - Healthy Kids Act HR 849 - Protecting Seniors' Access to Medicare Act of 2017 S. 3477 (114th Congress) - Protecting Seniors through Immunization Act Monograph Reform Tax Reform 340 B Reform
2017 · third_quarter · Health Issues
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. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies 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. 934: FDA Reauthorization Act of 2017 - Provisions related to user fee program 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 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. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies 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. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs 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. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2430: FDA Reauthorization Act of 2017 - Provisions related to user fee programs H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Provisions related to amending the Controlled Substances Act H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) 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 Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Proposed Rule delaying the effective date of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; RIN 0906-AB11 (82 Fed. Reg. 39553 (August 21, 2017)) Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Clinical trial policy issues Tax reform policy issues Cancer drug vial size policy issues A Better Deal economic platform proposal - Provisions related to drug cost and pricing policy issues TRICARE pharmacy pilot program
2017 · third_quarter · Pharmacy
Design and coverage of pharmacy benefits in Exchanges and the commercial market, including: EHB, grandfathering, Rx quality, eRx, EPCS, electronic prior authorization, PBM disclosure, MLR, and specialty pharmacy tiering. Implementation of biosimilars pathway from BPCIA. Policies placing restrictions on pharmacy benefit design. Issues relating to prescription drug affordability. REMS reform. Prescription drug user fee reauthorization. HR 1854; S. 788; HR 2025.
Client expense: $685,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Personnel Management (OPM), SENATE, White House Office
2017 · third_quarter · Pharmacy
FDA regulation of opioid abuse deterrent formulations H.R. 2430 (FDA Reauthorization Act of 2017), provisions relating to drugs H.R. 2025 (Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017), all provisions
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Natl Drug Control Policy (NDCP), SENATE
2017 · third_quarter · Health Issues
H.R. 2025, the Abuse Deterrent Opioids Plan for Tomorrow.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · third_quarter · Copyright/Patent/Trademark
H.R. 2025, the Abuse Deterrent Opioids Plan for Tomorrow.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · third_quarter · Pharmacy
H.R.2025, Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 Discussions regarding opioid abuse Discussions regarding 340B drug discount program
Client expense: $110,000 · Firm income: Not reported
2017 · third_quarter · Health Issues
HR 2025, Abuse-Deterrent Opioids Plan for Tomorrow Act; and FDA regulatory issues.
Client expense: Not reported · Firm income: $45,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · second_quarter · Copyright/Patent/Trademark
Abuse-deterrent opioid exclusivity policy issues H.R. 2025, provisions related to abuse-deterrent opioid exclusivity
Client expense: $180,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · second_quarter · Health Issues
Better Care Reconciliation Act of 2017 - Provisions related to repeal of the Affordable Care Act (ACA) and changes to Medicaid (discussion draft) 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. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies 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. 934: FDA Reauthorization Act of 2017 - Provisions related to user fee program 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. 3477 (from the 114th Congress), Protecting Seniors Through Immunization Act of 2016- HR 1628, American Health Care Act- HR 1628, Better Care Reconciliation Act of 2017- HR 2810, National Defense Authorization Act- HR 2430, the FDA Reauthorization Act of 2017- S. 934, the FDA Reauthorization Act of 2017- HR 244, Consolidated Appropriations Act of FY 2017Issues:Drug ImportationMedicare Non-interferenceTaxesBiosecurityHIV OTC Monograph Reform HR 2430/S 934 - FDA Reauthorization Act of 2017HR 1628 - American Health Care Act, Provisions related to reimbursement of OTC drugs under flexible and health savings accounts 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. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies 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. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs 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. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2430: FDA Reauthorization Act of 2017 - Provisions related to user fee programs H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Provisions related to amending the Controlled Substances Act to give DEA greater authority to schedule certain synthetic drugs H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Biologics User Fee Act (BsUFA) reauthorization Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) 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 Expanded access policy issues Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Interim Final Rule delaying the effective date of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; RIN 0906-AA89 (82 Fed. Reg. 14332 (March 20, 2017)) Orphan Drug Act policy issues Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Clinical trial policy issues Cancer drug vial size policy issues Nomination and Confirmation of Scott Gottlieb as FDA Commissioner
2017 · second_quarter · Health Issues
Trickett Wendler Right to Try Act of 2017 (S.204); Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 (H.R. 2851/S. 1327); Food and Drug Administration Reauthorization Act (S. 934/H.R. 2430); Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 (H.R. 2025); Medical Product Communications Act of 2017 (H.R. 1705); S. Amendment 178 to S. Con. Res. 3 (on importation of drugs from Canada); Fair Access for Safe and Timely (FAST) Generics Act (H.R. 2051) and CREATES Act (H.R. 2212/S. 974); Lower Drug Costs through Competition Act (H.R. 749) and Senate counterpart (S. 297, Increasing Competition in Pharmaceuticals Act); Affordable and Safe Prescription Drug Importation Act (S. 469/H.R. 1245); RACE for Children Act (S. 456/H.R. 1231); Safe and Affordable Drugs from Canada Act of 2017 (S. 92); Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2018 (H.R.3268); Preserving Patient Access to Compounded Medications Act of 2017 (H.R. 2781)
Client expense: Not reported · Firm income: $430,000
2017 · second_quarter · Health Issues
Better Care Reconciliation Act of 2017 - Provisions related to repeal of the Affordable Care Act (ACA) and changes to Medicaid (discussion draft) 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. 204: Trickett Wendler Right to Try Act of 2017 - Provisions related to use of unapproved medical products by patients with a terminal illness S. 297: Increasing Competition in Pharmaceuticals Act - Provisions related to generic drug approvals S. 456: RACE for Children Act - Provisions related to pediatric studies 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. 934: FDA Reauthorization Act of 2017 - Provisions related to user fee program 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 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. 1108: Recall Unsafe Drugs Act of 2017 - Provisions related to drug recalls H.R. 1231: RACE for Children Act - Provisions related to pediatric studies 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. 1703: Medical Product Communications Act of 2017 - Provisions related to communications regarding intended uses of drugs 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. 2025: Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 - Provisions related to labeling information describing abuse-deterrent properties H.R. 2026: Pharmaceutical Information Exchange Act - Provisions related to economic and scientific information communications H.R. 2212: CREATES Act of 2017 - Provisions related to REMS and limited distribution systems H.R. 2430: FDA Reauthorization Act of 2017 - Provisions related to user fee programs H.R. 2851: Stop the Importation and Trafficking of Synthetic Analogues Act of 2017 - Provisions related to amending the Controlled Substances Act to give DEA greater authority to schedule certain synthetic drugs H.R. 2871: Preserving Patient Access to Compounded Medications Act of 2017 - Provisions related to drug compounding Prescription Drug User Fee Act (PDUFA) reauthorization and related issues Biologics User Fee Act (BsUFA) reauthorization Biopharmaceutical innovation policy issues Reforms to the Pediatric Research Equity Act (PREA) and Best Pharmaceuticals for Children Act (BPCA) 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 Expanded access policy issues Expedited drug approval policy issues Generic drug approval process policy issues Sharing of truthful and non-misleading information about medicines with healthcare professionals and payors Risk Evaluation and Mitigation Strategy (REMS) policy issues Vaccines policy issues Limited distribution systems in the pharmaceutical supply chain policy issues FDA modernization policy issues 340B drug discount program policy issues Interim Final Rule delaying the effective date of the 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation; RIN 0906-AA89 (82 Fed. Reg. 14332 (March 20, 2017)) Orphan Drug Act policy issues 21st Century Cures Act (Public Law 114-255) - Provisions related to biopharmaceutical discovery, development, delivery, and transparency Senate HELP Committee Innovation Agenda - Provisions related to biopharmaceutical discovery and development and FDA policy Food and Drug Administration Safety and Innovation Act (FDASIA) policy issues Biologics Price Competition and Innovation Act (BPCIA) implementation issues Patient assistance program policy issues Biosimilar approval and reimbursement policy issues Drug compounding policy issues including federal oversight of compounded drugs Clinical trial policy issues Cancer drug vial size policy issues Nomination and Confirmation of Scott Gottlieb as FDA Commissioner
2017 · second_quarter · Pharmacy
Design and coverage of pharmacy benefits in Exchanges and the commercial market, including: EHB, grandfathering, Rx quality, eRx, EPCS, electronic prior authorization, PBM disclosure, MLR, and specialty pharmacy tiering. Implementation of biosimilars pathway from BPCIA. Policies placing restrictions on pharmacy benefit design. Issues relating to prescription drug affordability. REMS reform. Prescription drug user fee reauthorization. HR 1854; S. 788; HR 2025.
Client expense: $680,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Personnel Management (OPM), SENATE, White House Office
2017 · second_quarter · Pharmacy
FDA regulation of opioid abuse deterrent formulations H.R. 2430 (FDA Reauthorization Act of 2017), provisions relating to drugs H.R. 2025 (Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017), all provisions
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Natl Drug Control Policy (NDCP), SENATE, Vice President of the U.S., White House Office
2017 · second_quarter · Health Issues
H.R. 2025, the Abuse Deterrent Opioids Plan for Tomorrow.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · second_quarter · Copyright/Patent/Trademark
H.R. 2025, the Abuse Deterrent Opioids Plan for Tomorrow.
Client expense: Not reported · Firm income: $30,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · second_quarter · Pharmacy
H.R.2025, Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017 H.R.2430 and S.934, FDA Reauthorization Act of 2017
Client expense: $150,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES
2017 · second_quarter · Health Issues
Prescription Drug User Fee Act Re-authorization; HR 2025, Abuse-Deterrent Opioids Plan for Tomorrow Act.
Client expense: Not reported · Firm income: $15,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2017 · second_quarter · Health Issues
Prescription Drug User Fee Act Re-authorization, H.R. 2025, the Abuse-Deterrent Opioids Plan for Tomorrow Act.
Client expense: Not reported · Firm income: Not reported
2017 · second_quarter · Health Issues
H.R. 2025, the Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017.
Client expense: Not reported · Firm income: Not reported
2017 · second_quarter · Copyright/Patent/Trademark
H.R. 2025, the Abuse-Deterrent Opioids Plan for Tomorrow Act of 2017.
Client expense: Not reported · Firm income: Not reported
2017 · first_quarter · Pharmacy
Design and coverage of pharmacy benefits in Exchanges and the commercial market, including: EHB, grandfathering, Rx quality, eRx, EPCS, PBM disclosure, MLR, and specialty pharmacy tiering. Implementation of biosimilars pathway from BPCIA. Policies placing restrictions on pharmacy benefit design. Issues relating to prescription drug affordability. REMS reform. Prescription drug user fee reauthorization. HR 1854; S. 788; HR 2025.
Client expense: $645,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Internal Revenue Service (IRS), Labor, Dept of (DOL), Medicare Payment Advisory Commission (MedPAC), Office of Personnel Management (OPM), SENATE, White House Office
Client expense: $5,990,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
Client expense: $5,540,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Federal Trade Commission (FTC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institute of Standards & Technology (NIST), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Client expense: $1,110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Congressional Budget Office (CBO), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Administration, Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
Client expense: $9,960,000 · 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), Office of Administration, Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE
Client expense: $1,110,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Labor, Dept of (DOL), Natl Economic Council (NEC), Office of Management & Budget (OMB), Patent & Trademark Office (PTO), SENATE
Client expense: $5,880,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Council of Economic Advisers (CEA), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE
Client expense: $650,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE
Client expense: $5,570,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Defense, Dept of (DOD), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Natl Economic Council (NEC), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, White House Office
Client expense: $780,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR), White House Office
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: $6,000,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Executive Office of the President (EOP), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Health Resources & Services Administration (HRSA), Office of Management & Budget (OMB), Office of the Vice President of the United States, Patent & Trademark Office (PTO), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR), White House Office