Legislative Progress
Momentum (last 30 days)
0
score
0 actions · 0 new cosponsors · 0 votes
Speed vs cohort
43pct
7d open
vs 6,526 other HR bills in the 114th — cohort avg 56d
Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or the PATIENT Act of 2015 This bill amends the Federal Food, Drug, and Cosmetic Act to extend to five years the three-year marketing exclusivity period provided to certain new drugs that include an active ingredient that was already approved by the Food and Drug Administration. A drug is provided this extended exclusivity period if it is approved for a new indication or use, or the drug has been reformulated or redesigned to: promote greater patient adherence to an approved treatment regime, reduce the public health risks associated with the drug, reduce side effects or adverse events, provide benefits to the health-care system, or provide other comparable patient benefits.
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 (6)
2016 · third_quarter · Health Issues
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
Lobbied on issues related to abuse deterrent formulations of drugs and prescription drug abuse FDA proposed rule on generic drug labels S. 484 and HR 1353 PATIENTS Act of 2015 Senate HELP working group on Innovation for Healthier Americans
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · fourth_quarter · Pharmacy
Prescription drug abuse; drug labeling and electronic labeling proposals; counterfeit drug proposals; FY 2017 Appropriations for Agriculture, Rural Development, Food & Drug Administration and Related Agencies; FY 2017 Labor, HHS & Related Agencies Appropriations; "21st Century Cures" review/initiative; HR 9, Innovation Act; HR 1353 PATIENT Act; Section 505(b)(2) new drug applications and exclusivity period; drug pricing proposals and issues; and biosimilars reimbursement.
Client expense: $1,170,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2016 · fourth_quarter · Pharmacy
Prescription drug abuse; drug labeling and electronic labeling proposals; counterfeit drug proposals; FY 2017 Appropriations for Agriculture, Rural Development, Food & Drug Administration and Related Agencies; FY 2017 Labor, HHS & Related Agencies Appropriations; "21st Century Cures" review/initiative; HR 9, Innovation Act; HR 1353 PATIENT Act; Section 505(b)(2) new drug applications and exclusivity period; drug pricing proposals and issues; and biosimilars reimbursement.
Client expense: $930,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2016 · fourth_quarter · Health Issues
Lobbied on issues related to abuse deterrent formulations of drugs and prescription drug abuse FDA proposed rule on generic drug labels S. 484 and HR 1353 PATIENTS Act of 2015 21st Century Cures/innovation
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · third_quarter · Pharmacy
Prescription drug abuse; drug labeling and electronic labeling proposals; counterfeit drug proposals; FY 2017 Appropriations for Agriculture, Rural Development, Food & Drug Administration and Related Agencies; FY 2017 Labor, HHS & Related Agencies Appropriations; "21st Century Cures" review/initiative; HR 9, Innovation Act; HR 1353 PATIENT Act; Section 505(b)(2) new drug applications and exclusivity period; drug pricing proposals and issues; and biosimilars reimbursement.
Client expense: $940,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2016 · second_quarter · Health Issues
Lobbied on issues related to abuse deterrent formulations of drugs and prescription drug abuse FDA proposed rule on generic drug labels S. 484 and HR 1353 PATIENTS Act of 2015 Senate HELP working group on Innovation for Healthier Americans
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Health Issues
21st Century Cures; S. 484 and H.R. 1353, PATIENTS Act of 2015; Innovation for Healthier Americans
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Alcohol and Drug Abuse
21st Century Cures; S. 484 and H.R. 1353, PATIENTS Act of 2015; Innovation for Healthier Americans
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · second_quarter · Pharmacy
Prescription drug abuse; drug labeling and electronic labeling proposals; counterfeit drug proposals; FY 2017 Appropriations for Agriculture, Rural Development, Food & Drug Administration and Related Agencies; FY 2017 Labor, HHS & Related Agencies Appropriations; "21st Century Cures" review/initiative; HR 9, Innovation Act; HR 1353 PATIENT Act; Section 505(b)(2) new drug applications and exclusivity period; and drug pricing proposals and issues.
Client expense: $930,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2016 · first_quarter · Health Issues
Lobbied on issues related to abuse deterrent formulations of drugs and prescription drug abuse FDA proposed rule on generic drug labels S. 484 and HR 1353 PATIENTS Act of 2015 Senate HELP working group on Innovation for Healthier Americans
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Pharmacy
Prescription drug abuse; drug labeling and electronic labeling proposals; counterfeit drug proposals; FY 2017 Appropriations for Agriculture, Rural Development, Food & Drug Administration and Related Agencies; FY 2017 Labor, HHS & Related Agencies Appropriations; "21st Century Cures" review/initiative; HR 9, Innovation Act; HR 1353 PATIENT Act; Section 505(b)(2) new drug applications and exclusivity period; and drug pricing proposals and issues.
Client expense: $1,240,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2016 · first_quarter · Alcohol and Drug Abuse
21st Century Cures; S. 484 and H.R. 1353, PATIENTS Act of 2015; Innovation for Healthier Americans
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2016 · first_quarter · Health Issues
21st Century Cures; S. 484 and H.R. 1353, PATIENTS Act of 2015; Innovation for Healthier Americans
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
H.R.2029 - Consolidated Appropriations Act, 2016 Lobbied on issues related to abuse deterrent formulations of drugs and prescription drug abuse FDA proposed rule on generic drug labels S. 484 and HR 1353 PATIENTS Act of 2015 Senate HELP working group on Innovation for Healthier Americans
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Health Issues
21st Century Cures; S. 484 and H.R. 1353, PATIENTS Act of 2015; Innovation for Healthier Americans
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Alcohol and Drug Abuse
21st Century Cures; S. 484 and H.R. 1353, PATIENTS Act of 2015; Innovation for Healthier Americans
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · fourth_quarter · Pharmacy
Prescription drug abuse; drug labeling and electronic labeling proposals; counterfeit drug proposals; FY 2016 Appropriations for Agriculture, Rural Development, Food & Drug Administration and Related Agencies; FY 2016 Labor, HHS & Related Agencies Appropriations; "21st Century Cures" review/initiative; HR 9, Innovation Act; HR 1353 PATIENT Act; Section 505(b)(2) new drug applications and exclusivity period; and drug pricing proposals and issues.
Client expense: $900,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2015 · third_quarter · Health Issues
21st Century Cures; S. 484 and H.R. 1353, PATIENTS Act of 2015; Innovation for Healthier Americans
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · third_quarter · Alcohol and Drug Abuse
21st Century Cures; S. 484 and H.R. 1353, PATIENTS Act of 2015; Innovation for Healthier Americans
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · third_quarter · Health Issues
Lobbied on issues related to abuse deterrent formulations of drugs and prescription drug abuse FDA proposed rule on generic drug labels S. 484 and HR 1353 PATIENTS Act of 2015 Senate HELP working group on Innovation for Healthier Americans
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · third_quarter · Copyright/Patent/Trademark
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
2015 · third_quarter · Copyright/Patent/Trademark
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 214 - Preserve Access to Affordable Generics Act (113th Congress) - Provisions related to patent settlements S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity S. 2019: Preserve Access to Affordable Generics Act - Provisions related to patent settlements S. 2023: Prescription Drug Affordability Act of 2015 - Provisions related to patent settlements S. 2030: Advancing Targeted Therapies for Rare Diseases Act of 2015 - Provisions related to leveraging of data S. 2041: Promoting Life-Saving New Therapies for Neonates Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Patent settlement policy issues Biopharmaceutical innovation and patent policy issues
2015 · third_quarter · Pharmacy
Prescription drug abuse; drug labeling and electronic labeling proposals; counterfeit drug proposals; FY 2016 Appropriations for Agriculture, Rural Development, Food & Drug Administration and Related Agencies; HR 406, Combination Drug Development Incentive Act of 2015; "21st Century Cures" review/initiative; HR 9, Innovation Act; HR 1353 PATIENT Act; Section 505(b)(2) new drug applications and exclusivity period; and drug pricing proposals and issues.
Client expense: $990,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2015 · second_quarter · Alcohol and Drug Abuse
21st Century Cures; S. 484 and H.R. 1353, PATIENTS Act of 2015; Innovation for Healthier Americans
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · second_quarter · Health Issues
21st Century Cures; S. 484 and H.R. 1353, PATIENTS Act of 2015; Innovation for Healthier Americans
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · second_quarter · Copyright/Patent/Trademark
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion S. 926: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law S. 1137: PATENT Act - Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office (PTO) S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to exclusivity H.R. 9: Innovation Act - Provisions related to patent litigation and post-grant proceedings at the PTO H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1353: PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity H.R. 1791: Grace Period Restoration Act of 2015 - Provisions related to grace period and patent law H.R. 1832: Innovation Protection Act - Provisions related to patent office fees H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 - Provisions related to demand letters Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues and issues related to post-grant proceedings at the PTO Biopharmaceutical innovation and patent policy issues
2015 · second_quarter · Medicare/Medicaid
Legislative and regulatory issues that affect the prescription drug benefit or prescription drug affordability, including: HR244 (MAC Pricing); HR471 (Controlled Substances Registration); HR592 (Pharmacy Provider Status); HR69 (ASP Prompt Pay Exclusion); HR793 (Any Willing Pharmacy); HR804 (Access to Medicare Data); HR818 (PRIME Act); HR971 (OPEN Act); HR1021 (PIMA); HR1353 (New Therapeutic Entities); HR1735 (NDAA); HR2175 (FEHBP Transparency); HR2298 (Medicare Rx Abuse Prevention); S31 (Direct Negotiation); S314 (Pharmacy Provider Status); S1083 (Medicare Rebates); S1190 (Any Willing Pharmacy); S1364 (Medicaid Generic Rebates); S1376 (NDAA); S1431(Rx Abuse Prevention & Treatment).
Client expense: Not reported · Firm income: Not reported
2015 · second_quarter · Health Issues
Legislative and regulatory issues that affect the prescription drug benefit or prescription drug affordability, including: HR244 (MAC Pricing); HR471 (Controlled Substances Registration); HR592 (Pharmacy Provider Status); HR69 (ASP Prompt Pay Exclusion); HR793 (Any Willing Pharmacy); HR804 (Access to Medicare Data); HR818 (PRIME Act); HR971 (OPEN Act); HR1021 (PIMA); HR1353 (New Therapeutic Entities); HR1735 (NDAA); HR2175 (FEHBP Transparency); HR2298 (Medicare Rx Abuse Prevention); S31 (Direct Negotiation); S314 (Pharmacy Provider Status); S1083 (Medicare Rebates); S1190 (Any Willing Pharmacy); S1364 (Medicaid Generic Rebates); S1376 (NDAA); S1431(Rx Abuse Prevention & Treatment).
Client expense: Not reported · Firm income: Not reported
2015 · second_quarter · Defense
Legislative and regulatory issues that affect the prescription drug benefit or prescription drug affordability, including: HR244 (MAC Pricing); HR471 (Controlled Substances Registration); HR592 (Pharmacy Provider Status); HR69 (ASP Prompt Pay Exclusion); HR793 (Any Willing Pharmacy); HR804 (Access to Medicare Data); HR818 (PRIME Act); HR971 (OPEN Act); HR1021 (PIMA); HR1353 (New Therapeutic Entities); HR1735 (NDAA); HR2175 (FEHBP Transparency); HR2298 (Medicare Rx Abuse Prevention); S31 (Direct Negotiation); S314 (Pharmacy Provider Status); S1083 (Medicare Rebates); S1190 (Any Willing Pharmacy); S1364 (Medicaid Generic Rebates); S1376 (NDAA); S1431(Rx Abuse Prevention & Treatment).
Client expense: Not reported · Firm income: Not reported
2015 · second_quarter · Labor Issues/Antitrust/Workplace
Legislative and regulatory issues that affect the prescription drug benefit or prescription drug affordability, including: HR244 (MAC Pricing); HR471 (Controlled Substances Registration); HR592 (Pharmacy Provider Status); HR69 (ASP Prompt Pay Exclusion); HR793 (Any Willing Pharmacy); HR804 (Access to Medicare Data); HR818 (PRIME Act); HR971 (OPEN Act); HR1021 (PIMA); HR1353 (New Therapeutic Entities); HR1735 (NDAA); HR2175 (FEHBP Transparency); HR2298 (Medicare Rx Abuse Prevention); S31 (Direct Negotiation); S314 (Pharmacy Provider Status); S1083 (Medicare Rebates); S1190 (Any Willing Pharmacy); S1364 (Medicaid Generic Rebates); S1376 (NDAA); S1431(Rx Abuse Prevention & Treatment).
Client expense: Not reported · Firm income: Not reported
2015 · second_quarter · Pharmacy
Legislative and regulatory issues that affect the prescription drug benefit or prescription drug affordability, including: HR244 (MAC Pricing); HR471 (Controlled Substances Registration); HR592 (Pharmacy Provider Status); HR69 (ASP Prompt Pay Exclusion); HR793 (Any Willing Pharmacy); HR804 (Access to Medicare Data); HR818 (PRIME Act); HR971 (OPEN Act); HR1021 (PIMA); HR1353 (New Therapeutic Entities); HR1735 (NDAA); HR2175 (FEHBP Transparency); HR2298 (Medicare Rx Abuse Prevention); S31 (Direct Negotiation); S314 (Pharmacy Provider Status); S1083 (Medicare Rebates); S1190 (Any Willing Pharmacy); S1364 (Medicaid Generic Rebates); S1376 (NDAA); S1431(Rx Abuse Prevention & Treatment).
Client expense: Not reported · Firm income: Not reported
2015 · second_quarter · Postal
Legislative and regulatory issues that affect the prescription drug benefit or prescription drug affordability, including: HR244 (MAC Pricing); HR471 (Controlled Substances Registration); HR592 (Pharmacy Provider Status); HR69 (ASP Prompt Pay Exclusion); HR793 (Any Willing Pharmacy); HR804 (Access to Medicare Data); HR818 (PRIME Act); HR971 (OPEN Act); HR1021 (PIMA); HR1353 (New Therapeutic Entities); HR1735 (NDAA); HR2175 (FEHBP Transparency); HR2298 (Medicare Rx Abuse Prevention); S31 (Direct Negotiation); S314 (Pharmacy Provider Status); S1083 (Medicare Rebates); S1190 (Any Willing Pharmacy); S1364 (Medicaid Generic Rebates); S1376 (NDAA); S1431(Rx Abuse Prevention & Treatment).
Client expense: Not reported · Firm income: Not reported
2015 · second_quarter · Taxation/Internal Revenue Code
Legislative and regulatory issues that affect the prescription drug benefit or prescription drug affordability, including: HR244 (MAC Pricing); HR471 (Controlled Substances Registration); HR592 (Pharmacy Provider Status); HR69 (ASP Prompt Pay Exclusion); HR793 (Any Willing Pharmacy); HR804 (Access to Medicare Data); HR818 (PRIME Act); HR971 (OPEN Act); HR1021 (PIMA); HR1353 (New Therapeutic Entities); HR1735 (NDAA); HR2175 (FEHBP Transparency); HR2298 (Medicare Rx Abuse Prevention); S31 (Direct Negotiation); S314 (Pharmacy Provider Status); S1083 (Medicare Rebates); S1190 (Any Willing Pharmacy); S1364 (Medicaid Generic Rebates); S1376 (NDAA); S1431(Rx Abuse Prevention & Treatment).
Client expense: Not reported · Firm income: Not reported
2015 · second_quarter · Copyright/Patent/Trademark
H.R. 2045H.R. 2045: Targeting Rogue and Opaque Letters Act of 2015 Provisions related to demand letters H.R. 1353 PATIENT Act of 2015 Provisions related to extension of marketing exclusivity H.R. 971 Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Provisions related to extension of marketing exclusivity S. 1421S. 1421: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 Provisions related to exclusivity S. 1137 PATENT Act Provisions related to patent litigation reform and post-grant proceedings at the Patent and Trademark Office S. 926 Grace Period Restoration Act of 2015 Provisions related to grace period and patent law S. 632 STRONG Patents Act of 2015 Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9Innovation Actprovisions related to patent litigation reform S. 131Fair and Immediate Release of Generic Drugs Actprovisions related to patent settlements S. 632STRONG Patents Act of 2015provisions relating to post grant proceedings, bad faith demand letters, and PTO diversion No bill # assignedBiopharmaceutical innovation policy issues No bill # assignedBiologics data protection issues No bill # assignedIntellectual property issues Additional data exclusivity request that was part of 21st Century Cures submission
Client expense: $1,123,000 · Firm income: Not reported
2015 · second_quarter · Pharmacy
Prescription drug abuse; drug labeling and electronic labeling proposals; counterfeit drug proposals; FY 2016 Appropriations for Agriculture, Rural Development, Food & Drug Administration and Related Agencies; HR 406, Combination Drug Development Incentive Act of 2015; "21st Century Cures" review/initiative; HR 9, Innovation Act; HR 1353 PATIENT Act; Section 505(b)(2) new drug applications and exclusivity period; and drug pricing proposals and issues.
Client expense: $980,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
2015 · first_quarter · Health Issues
S 2948 Medicaid Generic Drug Price Fainess Act H.R.1353 PATIENT Act of 2015 Lobbied on issues related to abuse deterrent formulations of drugs and prescription drug abuse FDA proposed rule on generic drug labels
Client expense: Not reported · Firm income: $50,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · first_quarter · Alcohol and Drug Abuse
21st Century Cures; S. 484 and H.R. 1353, PATIENTS Act of 2015; Innovation for Healthier Americans
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · first_quarter · Health Issues
21st Century Cures; S. 484 and H.R. 1353, PATIENTS Act of 2015; Innovation for Healthier Americans
Client expense: Not reported · Firm income: $60,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2015 · first_quarter · Copyright/Patent/Trademark
S. 131: Fair And Immediate Release of Generic Drugs Act (FAIR Generics Act) - Provisions related to patent settlements and patent enforcement S. 481: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration S. 632: Support Technology and Research for Our Nations Growth Patents Act of 2015 or STRONG Patents Act of 2015 - Provisions related to post-grant proceedings, bad faith demand letters, and PTO diversion H.R. 9: Innovation Act - Provisions related to patent litigation H.R. 406: Combination Drug Development Incentive Act of 2015 - Provisions related to exclusivity and clinical investigations essential to approval H.R. 639: Improving Regulatory Transparency for New Medical Therapies Act - Provisions related to patent term restoration H.R. 971: Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015 (OPEN Act) - Provisions related to extension of marketing exclusivity H.R. 1353: Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or PATIENT Act of 2015 - Provisions related to extension of marketing exclusivity Draft legislation on demand letters, including Targeting Rogue and Opaque Letters (TROL) Act (113th Congress) Issues related to abuse deterrent exclusivity incentives Patent litigation reform issues Biopharmaceutical innovation and patent policy issues
Client expense: $5,440,000 · Firm income: Not reported
2015 · first_quarter · Pharmacy
Prescription drug abuse; drug labeling and electronic labeling proposals; counterfeit drug proposals; FY 2016 Appropriations for Agriculture, Rural Development, Food & Drug Administration and Related Agencies; HR 406, Combination Drug Development Incentive Act of 2015; "21st Century Cures" review/initiative; HR 9, Innovation Act; HR 1353 PATIENT Act; Drug pricing proposals and issues.
Client expense: $1,200,000 · Firm income: Not reported
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)
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| IN |
Client expense: $4,240,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, U.S. Trade Representative (USTR)
Client expense: $842,000 · Firm income: Not reported
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Client expense: $4,820,000 · Firm income: Not reported
Government targets: Congressional Budget Office (CBO), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), Office of Science & Technology Policy (OSTP), Patent & Trademark Office (PTO), SENATE, U.S. Trade Representative (USTR)
Government targets: Commerce, Dept of (DOC), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR), White House Office
Government targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Patent & Trademark Office (PTO), SENATE, State, Dept of (DOS), U.S. Trade Representative (USTR)