STEVEN GIULI

S. 2296, the National Defense Authorization Act for 2026, Section 878, Country-of-Origin Disclosure Requirements for Generic Drugs Purchased by the Department of Defense, provisions relating to prohibiting the Department of Defense from procuring for resale any generic drug unless the seller of such generic drug discloses the country the drug was manufactured in and the country of origin of all active pharmaceutical ingredients and key starting materials; Federal policy relating to providing incentives and federal funding to strengthen capabilities for domestic manufacturing of generic drugs; and Federal policy relating to inspection of foreign generic drug manufacturing facilities.

Federal policy relating to addressing drug shortages and strengthening pharmaceutical supply chains through partnerships with North American and other allied countries; Federal policy relating to providing preferential federal direct and indirect purchasing treatment for domestic and North American manufactured pharmaceuticals; S. 43, Skinny Labels Big Savings Act, provisions relating to providing a safe harbor from infringement for a method of use patent relating to drugs or biological products; and HR 1483/S. 1302, The Increasing Transparency in Generic Drug Applications Act, provisions relating to the Food and Drug Administrations authority to share information about ingredients and deviations in inactive ingredient concentration with generic pharmaceutical product applicants.

Executive Order 14231 and 14325, Amendment to Duties To Address the Flow of Illicit Drugs Across our Northern Border, provisions relating to the imposition of tariffs on products from Canada and the exemption of pharmaceuticals compliant with the United States-Mexico-Canada trade agreements from such tariffs; Executive Order 14257, Regulating Imports With A Reciprocal Tariff To Rectify Practices That Contribute To Large And Persistent Annual United States Goods Trade Deficits, provisions relating to the exemption of pharmaceuticals from reciprocal tariffs; Executive Order 14326, Further Modifying the Reciprocal Tarriff Rate, provisions relating to a zero percent tariff rate for non-patented articles for use in pharmaceutical applications; Federal policy relating to the United States-European Union Framework on an Agreement on Reciprocal, Fair, and Balanced Trade and the exemption of generic pharmaceuticals and their ingredients and precursor materials from tariffs; and Federal policy relating to the Department of Commerce's Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients [Docket No. 250414-006] and the exemption of pharmaceuticals compliant with the United States-Mexico-Canada trade agreement from any tariffs implemented following the completion of the Section 232 investigation.

Federal policy relating to requiring the Department of Defense to purchase domestically manufactured generic drugs and use active pharmaceutical ingredients and key starting materials sourced domestically or from eligible countries; and Federal policy relating to providing incentives and federal funding to strengthen capabilities for domestic manufacturing of generic drugs.

Federal policy relating to addressing drug shortages and strengthening pharmaceutical supply chains through partnerships with North American and other allied countries; Federal policy relating to providing preferential federal direct and indirect purchasing treatment for domestic and North American manufactured pharmaceuticals; and Federal policy relating to the structure of the Department of Health and Human Services.

Federal policy relating to requiring the Department of Defense to purchase domestically manufactured generic drugs and use active pharmaceutical ingredients and key starting materials sourced domestically or from eligible countries; and Federal policy relating to providing incentives to spur domestic manufacturing of generic drugs.

Federal policy relating to addressing drug shortages and strengthening pharmaceutical supply chains through partnerships with North American and other allied countries; Federal policy relating to the implementation of a pharmaceutical manufacturer reliability rating system and incentives in the Medicare program for providers to purchase generic drugs from manufacturers with higher reliability ratings; and Federal policy relating to the structure of the Department of Health and Human Services.

Federal policy relating to addressing drug shortages and strengthening pharmaceutical supply chains through partnerships with North American and other allied countries; Draft Senate Finance Committee drug shortage legislation (no bill number), provisions relating to Medicare reimbursement policies for generic drugs; Federal policy relating to the implementation of a pharmaceutical manufacturer reliability rating system and incentives in the Medicare program for providers to purchase generic drugs from manufacturers with higher reliability ratings; S. 5573, The Skinny Label Big Savings Act, provisions relating to creating a safe harbor for the use of the skinny labeling pathway for generic pharmaceuticals and biosimilars.

S. 4683, the National Defense Authorization Act for Fiscal Year 2025, Section 887, Requirement to produce domestically produced generic drugs, provisions relating to requiring the Department of Defense to purchase domestically manufactured generic drugs and use active pharmaceutical ingredients and key starting materials sourced domestically or from eligible countries; and Federal policy relating to providing incentives to spur domestic manufacturing of generic drugs.

Federal policy relating to addressing drug shortages and strengthening pharmaceutical supply chains through partnerships will North American and other allied countries; Draft Senate Finance Committee drug shortage legislation, provisions relating to Medicare reimbursement policies for generic drugs; Federal policy relating to the implementation of a pharmaceutical manufacturer reliability rating system and incentives in the Medicare program for providers to purchase generic drugs from manufacturers with higher reliability ratings;

S. 4683, the National Defense Authorization Act for Fiscal Year 2025, Section 887, Requirement to produce domestically produced generic drugs, provisions relating to requiring the Department of Defense to purchase domestically manufactured generic drugs and use active pharmaceutical ingredients and key starting materials sourced domestically or from eligible countries; Federal policy relating to providing tax incentives to spur domestic manufacturing of generic drugs; and Federal policy related to Administration for Strategic Preparedness and Response initiatives to strengthen domestic pharmaceutical manufacturing capabilities.

S. 2510, the RAPID Reserve Act, provisions relating to awarding contracts to US or OECD based generic drug manufacturers to establish a reserve of essential medicines; Federal policy relating to addressing drug shortages and strengthening domestic pharmaceutical manufacturing capabilities; Federal policy relating to requiring the military to purchase domestically manufactured generic drugs and use active pharmaceutical ingredients and key starting materials sourced domestically; Draft Senate Finance Committee drug shortage legislation, provisions relating to Medicare reimbursement policies for generic drugs; and Federal policy relating to rebating impacts on access to biosimilars

S. 2510, the RAPID Reserve Act, provisions relating to awarding contracts to US or OECD based generic drug manufacturers to establish a reserve of essential medicines; and Federal policy relating to addressing drug shortages and strengthening domestic pharmaceutical manufacturing capabilities.

S. 2510, the RAPID Reserve Act, provisions relating to awarding contracts to US or OECD based generic drug manufacturers to establish a reserve of essential medicines; and Federal policy relating to addressing drug shortages and strengthening domestic pharmaceutical manufacturing capabilities.

Federal policy relating to the approval of generic versions of pharmaceutical inhalation products; and Federal policy relating to DEA quotas and the availability of generic ADHD medicines

S. 2510, the RAPID Reserve Act, provisions relating to awarding contracts to US or OECD based generic drug manufacturers to establish a reserve of essential medicines; and Federal policy relating to addressing drug shortages and strengthening domestic pharmaceutical manufacturing capabilities.

Federal policy relating to the approval of generic versions of pharmaceutical inhalation products; and Federal policy relating to DEA quotas and the availability of generic ADHD medicines

Federal policy relating to formulary placement of generic drugs and biosimilars; and S. 2333, the Pandemic and All-Hazards Preparedness Act, Title V, Section 501, Improving Notification Procedures In Case of Increased Demand for Critical Drugs, provisions relating to reporting the discontinuance of manufacturing drugs and active pharmaceutical ingredients.

S. 2510, the RAPID Reserve Act, provisions relating to awarding contracts to US or OECD based generic drug manufacturers to establish a reserve of essential medicines; S. Amendment 532 to S. 2226, the National Defense Authorization Act, provisions relating to reviewing domestic biopharmaceutical manufacturing capabilities; and Federal policy relating to addressing drug shortages and strengthening domestic pharmaceutical manufacturing capabilities.

Federal policy relating to addressing drug shortages and strengthening domestic pharmaceutical manufacturing capabilities.

S 1114, the Expanding Access to Low-Cost Generics Act, provisions relating to the amendment of the Hatch-Waxman Act's 180-day exclusivity framework.

S 1114, the Expanding Access to Low-Cost Generics Act, provisions relating to the amendment of the Hatch-Waxman Act's 180-day exclusivity framework

Federal policy relating to the strengthening domestic pharmaceutical manufacturing capabilities

H.R. 2853, the BLOCKING Act, provisions relating to amending the Hatch-Waxman Act's 180-day exclusivity structure; and S. 4348, the Food and Drug Safety and Landmark Advancements Act, Section 515, 180 Day Exclusivity Period, provisions relating to amending the Hatch-Waxman Act's 180-day exclusivity structure to prevent market blockages.

HR 6833, the Continuing Appropriations and Ukraine Supplemental Appropriations Act of 2023, provisions in Division F, User Fee Reauthorization Act of 2022, relating to the reauthorization of the Generic Drug User Fee Act.

HR 5376, The Inflation Reduction Act, provisions in Subtitle B-Prescription drug pricing relating to authorization of to Medicare negotiate Part D and B drug prices with pharmaceutical manufacturers, prescription drug inflation rebates, and changes to the Medicare Part D program.

HR 7667, the Food and Drug Amendments of 2022, Title III, Fees Relating to Generic Drugs, provisions relating to the reauthorization of the Generic Drug User Fee Act; S 4348, Food and Drug Safety and Landmark Advancement Act, Title III, Fees Relating to Generic Drugs, provisions relating to the reauthorization of the Generic Drug User Fee Act; Senator Tina Smith Amendment #1 to S 4348, provisions relating to amending the Hatch-Waxman 180 exclusivity structure to prevent market blockages; HR 2853, the BLOCKING Act, provisions relating to amending the Hatch-Waxman Act 180-day exclusivity structure; and S2910, Expanding Access to Low Cost Generics Act, provisions relating to amending the Hatch-Waxman Act's 180-day exclusivity structure.

HR 2853, the BLOCKING Act, provisions relating to amending the Hatch-Waxman Act 180-day exclusivity structure; S2910, Expanding Access to Low Cost Generics Act, provisions relating to amending the Hatch-Waxman Act's 180-day exclusivity structure; and HR 6431, the Data Transparency and Drug Safety Act of 2022, provisions relating to drug manufacturing data retentions requirements.

Federal policy relating to strengthening domestic manufacturing of active pharmaceutical ingredients and finished dosages.

Executive Order No. 14017, America's Supply Chains (February 24, 2021), provisions relating to strengthening domestic manufacturing of active pharmaceutical ingredients and finished dosages

HR 5376, the Build Back Better Act, Sections 139001, 139101, 131902 provisions relating to negotiating Medicare prescription drug prices, Medicare Part B pharmaceutical rebates, and Medicare Part D rebates respectively; HR 2853, the BLOCKING Act, provisions relating to amending the Hatch-Waxman Act 180-day exclusivity structure; S2910, Expanding Access to Low Cost Generics Act, provisions relating to amending the Hatch-Waxman Act's 180-day exclusivity structure; S2740, the Promoting Readiness and Ensuring Proper Active pharmaceutical ingredient Reserves of Essential Medicines Act of 2021, provisions relating to establishing a strategic national stockpile of active pharmaceutical ingredients for essential medicines; and HR 2870, the Essential Medicines Strategic Stockpile Act of 2021, provisions relating to creating a pilot program with private entities to test the effectiveness of acquiring, maintaining, managing, and distributing a stockpile of generic drugs at risk of shortage.

Federal policy relating to the establishment of a strategic national stockpile for active pharmaceutical ingredients; HR 2853, the BLOCKING Act, provisions relating to amending the Hatch-Waxman Act 180-day exclusivity structure; Federal policy relating to amending the Hatch-Waxman Act's 180 day exclusivity framework to prevent market blockages; Federal policy relating to the establishment of an enhanced approval pathway for complex generic drugs; and Federal policy related to suitability petitions and the submission of Abbreviate New Drug Applications (ANDAs).

Executive Order No. 14017, America's Supply Chains (February 24, 2021), provisions relating to strengthening domestic manufacturing of active pharmaceutical ingredients and finished dosages.

Federal policy relating to the establishment of a strategic national stockpile for active pharmaceutical ingredients; HR 2853, the BLOCKING Act, provisions relating to amending the Hatch-Waxman Act 180-day exclusivity structure; Federal policy relating to amending the Hatch-Waxman Act's 180 day exclusivity framework to prevent market blockages; Federal policy relating to the establishment of an enhanced approval pathway for complex generic drugs; and Federal policy related to suitability petitions and the submission of Abbreviate New Drug Applications (ANDAs).

Executive Order No. 14017, America's Supply Chains (February 24, 2021), provisions relating to strengthening domestic manufacturing of active pharmaceutical ingredients and finished dosages.

Federal policy relating to the Hatch-Waxman Act's 180 day exclusivity framework; Federal policy relating to the approval of complex generic drug product applications; and Federal policy relating to the US pharmaceutical supply chain.

HR 938, the Bringing Low-cost Options and Competition while Keeping Incentives for new Generics (BLOCKING) Act of 2019, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework

HR 8529, the Protecting Access to Affordable Medicines Act, provisions relating to Medicaid rebate penalties on generic drugs

HR 938, the Bringing Low-cost Options and Competition while Keeping Incentives for new Generics (BLOCKING) Act of 2019, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework; and Federal policy relating to global drug supply chain issues.

HR 938, the Bringing Low-cost Options and Competition while Keeping Incentives for new Generics (BLOCKING) Act of 2019, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework; and HR 748, the Coronavirus Aid, Relief, and Economic Security (CARES) Act (P.L. 116-136), Part 1-Addressing Supply Shortages, Section 3112, additional manufacturer reporting requirements in response to drug shortages, provisions relating to reporting requirements for pharmaceutical manufacturers; and Federal policy relating to global drug supply chain issues.

HR 938, the Bringing Low-cost Options and Competition while Keeping Incentives for new Generics (BLOCKING) Act of 2019, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework; and HR 748, the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Part 1-Addressing Supply Shortages, Section 3112, additional manufacturer reporting requirements in response to drug shortages, provisions relating to the volume of pharmaceutical products manufactured for commercial sale in the US market.

HR 987, the Strengthening Health Care and Lowering Prescription Drug Costs Act, Title I, Subtitle A, Section 101, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework; S. 1895, the Lower Health Care Costs Act, Title II, Section 205, Preventing Blocking of Generic Drugs, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework; Federal policy relating to pharmaceutical market blockages caused by parked Hatch-Waxman 180-day exclusivity periods; HR 1865, the Further Consolidated Appropriations Act, Subtitle F, Section 605, provisions relating to the definition of chemically synthesized biologic products; and S. 3092, the Expanding Access to Low-Cost Generics Act, provisions relating to the amendment of the Hatch-Waxman Act to prevent parked 180-day exclusivity periods from blocking timely competition in the pharmaceutical marketplace

HR 987, the Strengthening Health Care and Lowering Prescription Drug Costs Act, Title I, Subtitle A, Section 101, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework; S. 1895, the Lower Health Care Costs Act, Title II, Section 205, Preventing Blocking of Generic Drugs, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework; and Federal policy relating to pharmaceutical market blockages caused by parked Hatch-Waxman 180-day exclusivity periods

S.340/HR 965, the Creating and Restoring Equal Access to Equivalent Samples Act of 2017, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, and for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals; H.R. 1506, the Fair And Immediate Release of Generic Drugs Act, provisions relating to pharmaceutical market blockages caused by "parked" Hatch-Waxman 180 day exclusivity periods; HR 938, the Bringing Low-cost Options and Competition While Keeping Incentives for New Generics Act, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework; HR 987, Strengthening Health Care and Lowering Prescription Drug Costs, Title I, Subtitle A, Section 101, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework; S. 1895-Lower Health Care Costs Act Section 205, Preventing Blocking of Generic Drugs, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework; Federal policy relating to pharmaceutical market blockages caused by parked Hatch-Waxman 180-day exclusivity periods; and HR 1499, the Protecting Consumer Access to Generic Drugs Act of 2019, provisions relating to patent settlements between brand and generic drug companies.

S. 340/HR965, the Creating and Restoring Equal Access to Equivalent Samples Act of 2017, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, and for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals; HR 938, the Bringing Low-cost Options and Competition While Keeping Incentives for New Generics Act, provisions relating to the Hatch-Waxman Acts 180-day exclusivity framework; Federal policy relating to pharmaceutical market blockages caused by parked Hatch-Waxman 180-day exclusivity periods; HR 1520, the Purple Book Continuity Act of 2019, provisions relating to publication of patents for biological products in the FDA Purple Book; HR 1503, the Orange Book Transparency Act of 2019, provisions relating to ensuring the FDAs Orange Book is accurate and up to date; HR 1499, the Protecting Consumer Access to Generic Drugs Act of 2019, provisions relating to patent settlements between brand and generic drug companies; Federal policy relating to generic pharmaceutical drug prices; and Implementation of Public Law 115-52, the FDA Reauthorization Act of 2017, Section 808, Incentivizing Generic Drug Developments, provisions relating to exclusivity for competitive generic therapies.

Federal policy related to the inclusion of provisions that enhance and facilitate generic drug and biosimilar competition in the United States Mexico Canada Trade Agreement.

S. 974/HR2212, the Creating and Restoring Equal Access to Equivalent Samples Act of 2017, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, and for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals; S. 2476, the Expanding Access to Low Cost Generics Act, provisions relating to pharmaceutical market blockages caused by "parked" Hatch-Waxman 180-day exclusivity periods; Federal policy relating to pharmaceutical market blockages caused by parked Hatch-Waxman 180-day exclusivity periods; Federal policy relating to generic pharmaceutical drug prices; Public Law 115-52, the FDA Reauthorization Act of 2017, Section 808, Incentivizing Generic Drug Developments, provisions relating to exclusivity for competitive generic therapies; and Federal policy relating to FDA proposed rule Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products, Docket No. FDA-2007-N-0363, RIN 0910-AG18

Federal policy related to the inclusion of provisions that enhance and facilitate generic drug and biosimilar competition in a revised North American Free Trade Agreement;

S. 974/H.R. 2212, the Creating and Restoring Equal Access to Equivalent Samples Act of 2017, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, and for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals; S. 2476, the Expanding Access to Low Cost Generics Act, provisions relating to pharmaceutical market blockages caused by "parked" Hatch-Waxman 180-day exclusivity periods; Federal policy relating to the Trump Administration's Fiscal Year 2019 Budget proposal to address pharmaceutical market blockages caused by parked Hatch-Waxman 180-day exclusivity periods; S. 2514, the Preserving Access to Cost Effective Drugs Act, provisions relating to the prohibition of the use of sovereign immunity to subvert review of patents; Federal policy relating to generic pharmaceutical drug prices; and Federal policy relating to generic pharmaceutical drug prices.

S. 974/H.R. 2212, the Creating and Restoring Equal Access to Equivalent Samples Act of 2017, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, and for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals; S. 2476, the Expanding Access to Low Cost Generics Act, provisions relating to pharmaceutical market blockages caused by "parked" Hatch-Waxman 180 day exclusivity periods; Federal policy relating to the Trump Administration's Fiscal Year 2019 Budget proposal to address pharmaceutical market blockages caused by parked Hatch-Waxman 180 day exclusivity periods; S. 124, the Preserve Access to Affordable Generics Act, provisions relating to pharmaceutical patent settlements between generic and brand drug manufacturers; and Federal policy relating to the impact of rebates on the development of the biosimilars market.

Federal policy related to the inclusion of provisions that enhance and facilitate generic drug and biosimilar competition in a revised North American Free Trade Agreement; and Federal policy related to the exclusion of pharmaceutical products from the list of products imported from China identified by the Trump Administration that are subject to additional tariffs.

Federal policy related to the inclusion of provisions that enhance and facilitate generic drug and biosimilar competition in a revised North American Free Trade Agreement

Federal policy related to Section 603, Applying the Medicaid additional rebate requirement to generics, of Public Law No 114-67, the Bipartisan Budget Act of 2015; and S. 2476, the Expanding Access to Low Cost Generics Act, provisions relating to pharmaceutical market blockages caused by "parked" Hatch-Waxman 180 day exclusivity periods.

HR 1892, the Bipartisan Budget Act of 2018, related to the inclusion of S.974/HR 2212, the Creating and Restoring Equal Access to Equivalent Samples Act; and HR 1625, the Consolidated Appropriations Act of 2018, related to the inclusion of S.974/HR 2212, the Creating and Restoring Equal Access to Equivalent Samples Act.

Federal policy related to Section 603, Applying the Medicaid additional rebate requirement to generics, of Public Law No 114-67, the Bipartisan Budget Act of 2015; and S. 2476, the Expanding Access to Low Cost Generics Act, provisions relating to pharmaceutical market blockages caused by "parked" Hatch-Waxman 180 day exclusivity periods.

Federal policy relating to inter partes review challenges of pharmaceutical and biotechnology patents.

Federal policy related to the inclusion of provisions that enhance and facilitate generic drug and biosimilar competition in a revised North American Free Trade Agreement

HR 2212/S. 974, the Creating and Restoring Equal Access to Equivalent Samples Act of 2017, and HR 2051, the Fair Access for Safe and Timely Generics Act of 2017, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, and for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals;and Federal policy relating to pharmaceutical pricing

HR 2430, the FDA Reauthorization Act of 2017, Title VIII, Improving Generic Drug Access, provisions relating to enhancing the generic drug approval process, spurring the development and approval of generic versions of drugs with limited competition, and generic drug exclusivity; and HR 2212/S. 974, the Creating and Restoring Equal Access to Equivalent Samples Act of 2017, and HR 2051, the Fair Access for Safe and Timely Generic Act of 2017, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, and for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals.

Federal policy relating to inter partes review challenges of pharmaceutical and biotechnology patents

HR 2430, the FDA Reauthorization Act of 2017, Title VIII, Improving Generic Drug Access, provisions relating to enhancing the generic drug approval process, spurring the development and approval of generic versions of drugs with limited competition, and generic drug exclusivity; S. 934, the FDA Reauthorization Act of 2017, Title IX, Generic Drug Access, provisions relating to enhancing the generic drug approval process and spurring the development and approval of generic versions of drugs with limited competition; HR 2212, the Creating and Restoring Equal Access to Equivalent Samples Act of 2017, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, and for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals; S. 974, the Creating and Restoring Equal Access to Equivalent Samples Act of 2017, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, and for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals; HR 2051, the Fair Access for Safe and Timely Generic Act of 2017, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, and for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals; and Federal policy related to repealing Section 603, Applying the Medicaid additional rebate requirement to generics, of Public Law No 114-67, the Bipartisan Budget Act of 2015

Federal policy relating to the reauthorization of the Generic Drug User Fee Act; Federal policy relating to the cost of prescription pharmaceuticals; Federal policy relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, and for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals; HR 749, the Lower Drug Costs Through Competition Act, provisions relating to priority review vouchers for and expedited approval of certain generic drug applications, and Risk Evaluation and Mitigation (REMS) programs; and Draft legislation (no bill number) related to generic drug exclusivity and the review of Abbreviated New Drug Applications (ANDAs).

Legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, including: H.R. 2841, The FAST Generics Act of 2015; S. 3056, the CREATES Act; H.R. 34, 21st Century Cures Act; and House Energy & Commerce Committee/Senate Health, Education, Labor and Pensions Committee draft legislative proposal.

Legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing, including: H.R. 2841, The FAST Generics Act of 2015; S. 3056, the CREATES Act; H.R. 34, 21st Century Cures Act; and House Energy & Commerce Committee/Senate Health, Education, Labor and Pensions Committee draft legislative proposal.

H.R. 2841, The FAST Generics Act of 2015, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; S. 3056, the CREATES Act, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; and Federal policy relating to the approval of pending abbreviated new drug applications for generic versions of Crestor

H.R. 2841, The FAST Generics Act of 2015, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; S. 3056, the CREATES Act, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; Federal policy relating to the approval of pending abbreviated new drug applications for generic versions of Crestor; and S. 1137, The Patent Act, Technical corrections to the Leahy-Smith American Invents Act and other improvements, provisions in Section 14 relating to the inter partes review process, including federal policy relating to the use of inter partes review challenges of pharmaceutical and biotechnology patents.

CMS final rule CMS-1631-FC, Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 16,provisions relating to reimbursement for biosimilar products

H.R. 2841, The FAST Generics Act of 2015, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; S. 2615, the Increasing Competition in Pharmaceuticals Act, provisions relating to priority review vouchers for and expedited approval of certain generic drug applications, and Risk Evaluation and Mitigation (REMS) programs; Federal policy relating to requirements for shared Risk Evaluation and Mitigation (REMS) programs for brand and generic pharmaceuticals; S. 131, The FAIR Generics Act, provisions relating to market blockages caused by "parked" 180 day exclusivity period; Federal policy relating to the Implementation of Public Law 112-144, The Food and Drug Administration Safety and Innovation Act, Title 3, Fees Relating to Generic Drugs; and Federal policy relating to generic drug prices.

HR 6, The 21st Century Cures Act, provisions relating to the discovery, approval and manufacturing of pharmaceuticals; Federal policy relating to issues affecting the generic drug industry within the Senate Health, Education, Labor and Pensions Committee's Innovation for Healthier Americans initiative; HR 2841, The FAST Generics Act of 2015, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; S 131, The FAIR Generics Act, provisions relating to market blockages caused by "parked" 180 day exclusivity periodd, and; S. 2019, The Preserve Access to Affordable Generics Act, provisions relating to the legality of patent settlements between brand and generic pharmaceutical companies; Federal policy relating to the Implementation of Public Law 112-144, The Food and Drug Administration Safety and Innovation Act, Title 3, Fees Relating to Generic Drugs.

HR 1314, The Bipartisan Budget Act of 2015, Title VI, Section 602, provisions relating to Medicaid rebates for generic drugs.

CMS proposed rule, Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 16, RIN 0938-AS40, provisions relating to reimbursement for biosimilar products

HR 6, The 21st Century Cures Act, provisions relating to the discovery, approval and manufacturing of pharmaceuticals; Federal policy relating to issues affecting the generic drug industry within the Senate Health, Education, Labor and Pensions Committee's Innovation for Healthier Americans initiative; HR 2841, The FAST Generics Act of 2015, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; S 1137, The FAIR Generics Act, provisions relating to market blockages caused by "parked" 180 day exclusivity periods; S. 2109, The Preserve Access to Affordable Generics Act, provisions relating to the legality of patent settlements between brand and generic pharmaceutical companies; Federal policy relating to the implementation of the Biologic Price Competition and Innovation Act, Title VII, Subtitle A, of Public Law 111-148, The Patient Protection and Affordable Care Act; and FDA proposed rule, Designation of Official Names for Certain Biological Products, Docket No. FDA-2015-N-0648, provisions related to nonproprietary naming for biologic products

HR 6 - The 21st Century Cures Act, provisions relating to the discovery, approval and manufacturing of pharmaceuticals; FDA proposed rule, Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; HR 2841 - The FAST Generics Act of 2015, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; S 1137 - The FAIR Generics Act, provisions relating to market blockages caused by "parked" 180 day exclusivity periods; Federal policy relating to International Nonproprietary Names for biosimilars; Federal policy relating to the implementation of the Biologic Price Competition and Innovation Act, Title VII, Subtitle A, of Public Law 111-148, The Patient Protection and Affordable Care Act; and Federal policy relating to the Implementation of Public Law 112-144, The Food and Drug Administration Safety and Innovation Act, provisions in Title 3, Fees Relating to Generic Drugs.

HR 9, the Innovation Act, provisions relating to patent infringement actions and improvements and technical corrections to the Leahy-Smith America Invents Act

FDA proposed rule, Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; House Energy & Commerce Committees 21st Century Cures discussion draft, provisions relating to federal policies regarding the discovery, approval and manufacturing of pharmaceuticals; Federal policy relating to International Nonproprietary Names for biosimilars; Federal policy relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; Federal policy relating to the implementation of the Biologic Price Competition and Innovation Act, Title VII, Subtitle A, of Public Law 111-148, the Patient Protection and Affordable Care Act, and; Federal policy relating to the Implementation of Public Law 112-144, The Food and Drug Administration Safety and Innovation Act, Title 3, Fees Relating to Generic Drugs

Federal policy relating to legal remedies for pharmaceutical companies in the Trans Pacific Partnership trade negotiations

FDA proposed rule, Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; Federal policy relating to issues affecting the generic drug industry within the House Energy and Commerce Committee's 21st Century Cures initiative; Federal policy relating to International Nonproprietary Names for Biosimilars; HR 5657, the Fair Access for Safe and Effective Generics Act, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; HR 5748/S 2948, the Medicaid Generic Drug Fairness Act, provisions relating to Medicaid rebates for generic pharmaceuticals; Federal policy relating to the use of generic drugs in the Medicare Part D program; Federal policy relating to the implementation of the Biologic Price Competition and Innovation Act, Title VII, Subtitle A, of Public Law 111-148, the Patient Protection and Affordable Care Act; and HR 3116, the MODDERN Cures Act, provisions relating to the exclusivity term for dormant therapies

FDA proposed rule,Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; HR 5657, the Fair Acess for Safe and Timely Generics Act of 2014, provisions relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; Federal policy relating to issues affecting the generic drug industry within the House Energy and Commerce Committee's 21st Century Cures initiative; Federal policy relating to International Nonroprietary Names for Biosimilars; and, Implementation of Public Law 112-144 - The Food and Drug Administration Safety and Innovation Act, federal policy relating to provisions in Title 3 regarding generic drug user fees.

FDA proposed rule,Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes;Potential legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; Proposed FDA rule, "Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products," RIN: 0910-AG18, provisions relating to the use of electronic package inserts for human pharmaceuticals and biologics; Federal policy relating to issues affecting the generic drug industry within the House Energy and Commerce Committee's 21st Century Cures initiative, and; Federal policy relating to International Nonroprietary Names for Biosimilars

Federal trade policy relating to the Canadian intellectual property system

Federal policy regarding Public Law 113-54, the Drug Quality and Security Act, Title II, Drug Supply Chain Security, Section 581, Definitions, provision relating to the definition of manufacturer;Potential legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; FDA proposed rule,Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes; Proposed FDA rule, "Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products," RIN: 0910-AG18, provisions relating to the use of electronic package inserts for human pharmaceuticals and biologics

S. 504, The Fair and Immediate Release of Generics Act, provisions relating to market blockages caused by parked 180 day exclusivity periods; S. 214, The Preserve Access to Affordable Pharmaceuticals Act, provisions relating to the legality of "reverse payment" patent settlements;Federal Trade Commission v. Actavis Supreme Court Case No. 12-416 as this case pertains to S. 504, S. 214, and to federal policy on "reverse payment" settlements; Potential legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; HR 3204, the Drug Quality and Security Act, Title II, Drug Supply Chain Security, provisions relating to the establishment of a federal track and trace system for pharmaceuticals; Implementation of Public Law 112-144 The Food and Drug Administration Safety and Innovation Act, federal policy relating to provisions in Title 3 regarding generic drug user fees; H.R. 2725, FDA Safety Over Sequestration Act, provisions relating to the exemption of FDA user fees from sequestration-imposed cuts to the federal budget; FDA proposed rule titled Supplemental Applications Proposing Labeling Changes For Approved Drugs And Biological Products, Docket Number FDA-2013-N-0500, provisions relating to generic drug labeling changes

S. 504, The Fair and Immediate Release of Generics Act, provisions relating to market blockages caused by parked 180 day exclusivity periods; S. 214, The Preserve Access to Affordable Pharmaceuticals Act, provisions relating to the legality of "reverse payment" patent settlements;Federal Trade Commission v. Actavis Supreme Court Case No. 12-416 as this case pertains to S. 504, S. 214, and to federal policy on "reverse payment" settlements; Potential legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing; H.R. 1919, the Safeguarding America's Pharmaceutical Act of 2013, S. 959, the Pharmaceutical Compounding Quality and Accountability Act, Title II, Drug Supply Chain Security, HR 3204, the Drug Quality and Security Act, Title II, Drug Supply Chain Security, provisions relating to the establishment of a federal track and trace system for pharmaceuticals; Implementation of Public Law 112-144 The Food and Drug Administration Safety and Innovation Act, federal policy relating to provisions in Title 3 regarding generic drug user fees; Federal policy relating to International Nonproprietary Names for biosimilars

Trans-Pacific Partnership negotiations relating to the ability of brand and generic drug companies to settle patent litigation

S. 504, The Fair and Immediate Release of Generics Act, provisions relating to market blockages caused by parked 180 day exclusivity periods S. 214, The Preserve Access to Affordable Pharmaceuticals Act, provisions relating to the legality of "reverse payment" patent settlementsFederal Trade Commission v. Actavis Supreme Court Case No. 12-416 as this case pertains to S. 504, S. 214, and to federal policy on "reverse payment" settlements Potential legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing H.R. 1919, the Safeguarding America's Pharmaceutical Act of 2013, S. 959, the Pharmaceutical Compounding Quality and Accountability Act, Title II, Drug Supply Chain Security, provisions relating to the establishment of a federal track and trace system for pharmaceuticals Federal policy relating to the adoption of an electronic labeling system for pharmaceuticals, inlcuding as proposed in HR 1919 S. 1244, Fiscal Year 2014 Agriculture, Rural Development, Food and Drug Administration and Related Agencies Appropriations bill, Title VI, Related Agency and Food and Drug Administration, provisions relating to the sequester's impact on the generic drug user fee program

S. 504, The Fair and Immediate Release of Generics Act, relating to market blockages caused by parked 180 day exclusivity periods S. 214, The Preserve Access to Affordable Pharmaceuticals Act, relating to the legality of "reverse payment" patent settlements Federal Trade Commission v. Actavis Supreme Court Case No. 12-416, relating to federal policy on "reverse payment" settlementsFederal legislation relating to the provision of brand drug products by brand manufacturers to generic manufacturers for development testing Actelion Pharmaceutical LTD and Actelion Clinical Research Inc. V. Apotex Inc., Apotex Corp., and Roxane Laboratories Inc., United States District Court for the District of New Jersey, case 1:12-cvi-05743-NLH-AMD, relating to federal legislation regarding the provision of brand drug products by brand manufacturers to generic manufacturers for development testing Federal legisation relating to the establishment of a federal track and trace system for pharmaceuticals Federal policy relating to the adoption of an electronic labeling system for pharmaceuticals

S. 1882, The Fair and Immediate Release of Generics Act S. 27, The Preserve Access to Affordable Pharmaceuticals Act Actelion Pharmaceutical LTD and Actelion Clinical Research Inc. V. Apotex Inc., Apotex Corp., and Roxane Laboratories Inc. The use of Risk Evaluation and Mitigation Strategies (REMS) by brand drug companies to delay generic competition Establishment of a federal track and trace system for pharmaceuticals Adoption of an electronic labeling system for pharmaceuticals

S. 1882, The Fair and Immediate Release of Generics Act S. 27, the Preserve Access to Affordable Pharmaceuticals Act S. 3187.PCS/ES, the Food and Drug Administration Safety and Innovation Act, Title XI, Other Provisions, Subtitle C, Miscellaneous Provisionsm Section 1131, Drug Development and Testing Establishment of a federal track and trace system for pharmaceuticals HR 6322, the FDA User Fee Corrections Act of 2012 Actelion Pharmaceuticals LTD and Actelion Clinical Research Inc. v. Apotex Inc., Apotex Corp., and Roxane Laboratories Inc.

S. 1882, The Fair and Immediate Release of Generics Act S. 27, the Preserve Access to Affordable Pharmaceuticals Act HR 4332, the Generic Drug Application Review Fairness Act Amending Section 505(j) of the Food, Drug and Cosmetic Act, concerning the ability of generic pharmaceutical manufacturers to file counterclaims seeking the correction of incorrect patent information submitted to FDA's Orange Book by patent owners of New Drug Applications Supreme Court consideration of Novo Nordisk A/S and Novo Nordisk Inc. vs Caraco Pharmaceutical Laboratories Ltd. and Sun Pharmacuetical Industries Ltd. S. 2516, the Food and Drug Innovation and Safety Act: Title VIII, Generating Antibiotic Incentives, Title XI, Other Provisions, Section 1131, Drug Development and Testing HR 5651. the Food and Drug Administration Reform Act: Title VIII, Drug Regulatory Improvements, Subtitle F, Miscellaneous, Section 862, Extension of period for first applicant to obtain tentative approval without forfeiting 180-day exclusivity period, Section 863, Final agency action relating to petitions and civil actions S. 3187.PCS/.ES, the Food and Drug Administration Safety and Innovation Act: Title XI, Other Provisions, Subtitle C, Miscellaneous Provisions, Section 1131, Drug Development and Testing S AMDT 2111 to S. 3187, concerning pharmaceutical market blockages caused by parked 180 day exclusivity periods S. 3187.EAH, the Food and Drug Administration Safety and Innovation Act: Title XI, Other Provisions, Subtitle C, Miscellaneous Provisiosn, Section 1133, Extension of period for first applicant to obtain tentative approval without forfeiting 180 day exclusivity period, Section 1135, Final agency action related to petitions and civil actions Establishment of a federal track and trace system for pharmaceuticals

S. 1882, the FAIR Generics Act S. 27, the Preserve Access to Affordable Pharmaceuticals Act HR 3995, the Protecting Consumer Access to Generic Drugs Act S. 296, HR 2245, The Preserving Access to Life Savings Medications Act HR 4332, the Generic Drug Application Review Fairness Act HR 3998, Generic Drug and Biosimilar User Fee Act HR 2182, S. 1734, the Generating Antibiotic Incentives Now Act Amending Section 505(j) of the Food, Drug, and Cosmetic Act, concerning the ability of generic pharmaceutical manufacturers to file counterclaims seeking the correction of incorrect information submitted to FDA's Orange Book by patent owners or holders of New Drug Applications Supreme Court consideration of Novo Nordisk A/S and Novo Nordisk Inc. vs Caraco Pharmaceutical Laboratories Ltd. and Sun Pharmaceuticals Industries, Ltd. Prospective legislation establishing a generic drug user fee program Prospective legislation establishing a biosimilar user fee program Establishment of a federal track and trace system for pharmaceuticals The use of Risk Evaluation Mitigation Strategies (REMS) programs by brand drug companies to delay generic competition International Nonproprietary Names for Biosimilars

S. 27, the Preserve Access to Affordable Pharmaceuticals Act S. 1882, the FAIR Generics Act S. 296, HR 2245, The Preserving Access to Life Savings Medications Act Amending Section 505(j) of the Food, Drug, and Cosmetic Act, concerning the ability of generic pharmaceutical manufacturers to file counterclams seeking the correction of incorrect information submitted to FDA's Orange Book by patent owners or holders of New Drug Applications Supreme Court consideration of Novo Nordisk A/S and Novo Nordisk Inc. vs Caraco Pharmaceutical Laboratories Ltd. and Sub Pharmaceuticals Industries, Ltd. Prospective action on legislation establishing a generic drug user fee program Prospective action on legislation establishing a biosimilar user fee program Establishment of a federal track and trace system for pharmaceuticals Importation of prescription narcotic products into the United States The use of Risk Evaluation Mitigation Strategies (REMS) programs by brand drug companies to delay generic competition

S. 27 the Preserve Access to Affordable Pharmaceuticals Act Amending Section 505(j) of the Food, Drug, and Cosmetic Act, concerning the ability of generic pharmaceutical manufacturers to file counterclams seeking the correction of incorrect information submitted to FDA's Orange Book by patent owners or holders of New Drug Applications Supreme Court consideration of Novo Nordisk A/S and Novo Nordisk Inc. vs Caraco Pharmaceutical Laboratories Ltd. and Sub Pharmaceuticals Industries, Ltd. Prospective action on legislation establishing a generic drug user fee program Prospective action on legislation establishing a biosimilar user fee program S. 296, HR 2245, The Preserving Access to Life Savings Medications Act Establishment of a federal track and trace sstem for pharmaceuticals Importation of prescription narcotic products into the United States

S. 27, the Preserve Access to Affordable Pharmaceuticals Act Amending Section 505(j) of the Food, Drug, and Comsetic Act, concerning the ability of generic pharmaceutical manufacturers to file counterclaims seeking the correction of incorrect information submitted to FDA's Orange Book by patent owners or holders of New Drug Applications Supreme Court consideration of Novo Nordisk A/S and Novo Nordisk Inc. vs Carco Pharmaceutical Laboratories Ltd and Sun Pharmaceuticals Industries, Ltd Prospective action on legislation establishing a generic drug user fee program Prospection action on legislation establishing a biosimilar user fee program S. 296, the Preserving Access to Life Saving Medications Act Establishment of a federal track and trace system for pharmaceuticals

Exclusion of biologics policy from the intellectual property rights section of the Trans-Pacific Partnership

S. 23, the America Invents Act, Section 10, Supplemental Examination H.R. 1249, the American Invents Act, Section 11, Supplemental Examination

S. 27, the Preserve Access to Affordable Pharmaceuticals Act Amending Section 505(j)(5)(c)(ii)(I) of the Food, Drug and Cosmetic Act, concerning the ability of generic pharmaceutical manufacturers to file counterclaims seeking the correction of incorrect information submitted to FDA's Orange Book by patent owners or holders of New Drug Applications

S. 1315/HR 3777 the Drug Price Competition Act of 2009, all provisions S. 369 Preserve Access to Affordable Pharmaceuticals Act, all provisions Draft legislation concerning pharmaceutical manufacturing facility inspections, provision concerning registration fees for manufacturing facilities FDA Docket No. FDA-2010-N-0381 concerning generic drug user fees Propective action on legislation concerning the establishment of a generic drug user fee program Amending section 505(j)(5)(C)(ii)(I) of the Food, Drug and Cosmetic Act, concerning the ability of generic drug manufacturers to file counterclaims seeking the correction of incorrect information submitted to FDA's Orange Book by patent owners or holders of approved New Drug Applications.

S. 1315/HR 3777 the Drug Price Competition Act of 2009 S. 369, the Preserve Access to Affordable Pharmaceuticals Act SA 4361 to HR 4213 concerning market blockages caused by pharmaceutical patent settlements HR 759, Food and Drug Administration Globalization Act of 2009 Draft legislation concerning pharmaceutical manufacturing facility inspections Establishment of a generic drug user fee program

S. 1315/HR 3777 the Drug Price Competition Act of 2009 S. 369, the Preserve Access to Affordable Generics Act HR 4899 EAH, Supplemental Disaster Relief and Summer Jobs Act of 2010, Chapter 2, Section 4201, Preserve Access to Affordable Generics Act SA 4361 to HR 4213 concerning market blockages caused by pharmaceutical patent settlements HR 759, Food and Drug Administration Globalization Act of 2009 Pharmaceutical waste disposal

S 3606, FY 2011 Agriculture, Rural Development, Food & Drug administration and Related Agencies Act, funding for the FDA's Office of Generic Drugs

S. 1315/HR 3777 the Drug Price Competition Act of 2009 S. 369, the Preserve Access to Affordable Generics Act HR 4899 EAH, Supplemental Disaster Relief and Summer Jobs Act of 2010, Chapter 2, Section 4201, Preserve Access to Affordable Generics Act SA 4361 to HR 4213 concerning market blockages caused by pharmaceutical patent settlements HR 759, Food and Drug Administration Globalization Act of 2009 Pharmaceutical waste disposal

S 3606, FY 2011 Agriculture, Rural Development, Food & Drug administration and Related Agencies Act, funding for the FDA's Office of Generic Drugs

S. 1315/HR 3777 the Drug Price Competition Act of 2009 S. 369, the Preserve Access to Affordable Generics Act HR 4899 EAH, Supplemental Disaster Relief and Summer Jobs Act of 2010, Chapter 2, Section 4201, Preserve Access to Affordable Generics Act SA 4361 to HR 4213 concerning market blockages caused by pharmaceutical patent settlements HR 759, Food and Drug Administration Globalization Act of 2009 Pharmaceutical waste disposal

S. 369, the Preserve Access to Affordable Pharmaceuticals Act S. 1315, the Drug Price Competition Act of 2009 H.R. 3777, the Drug Price Competition Act of 2009 H.R. 3962, Affordable Health Care for America Act, Section 2573, Protecting Consumer Access to Generic Drugs Act H.R. 3962, Affordable Heatlh Care for America Act, Section 2375, Licensure Pathway for Biosimilar Products H.R. 3590, the Patient Protection and Affordable Care Act, Title VII, Subtitle A, Biologics Price Competition and Innovation H.R. 4872, the Health Care and Education Reconciliation Act of 2010 pertaining to patent settlements between brand and generic pharmaceutical manufacturers

HR 3962, the Affordable Healthcare For America Act, Title VII Medicaid and CHIP, Subtitle E, Financing, Section 1741, Payments to Pharmacists HR 3590, the Patient Protection and Affordable Care Act, Section 2503, Providing Adequate Pharmacy Reimbursement

S 369, the Preserve Access to Affordable Pharmaceuticals Act HR 1706, the Protecting Consumer Access to Generic Drugs Act S. 1315, the Drug Price Competition Act of 2009 HR 3777, the Drug Price Competition Act of 2009 HR 3200, Subtitle C, Food & Drug Administration, Secrtion 2563, Protecting Consumer Access to Generic Drugs Act HR 3962, Affordable Health Care for America Act, Section 2573, Protecting Consumer Access to Generic Drugs Act, Section 2575, Lincensure Pathway for Biosimilar Products HR 3590, the Patient Protection and Affordable Care Act, Title VII, Subtitle A, Biologics Price Competition and Innovation

HR 3200, Subtitle-E, Financing, Section 1741, Payment to Pharmacists Senate Finance and HELP Committee amendments concerning patent settlements between generic and brand drug companies

S. 515, the Patent Reform Act of 2009 concerning inequitable conduct

S. 369, the Preserve Access to Affordable Pharmaceuticals Act HR 1706, the Protecting Consumer Access to Generic Drugs Act S. 1315, the Drug Price Competition Act of 2009 HR 3200, Subtitle C - Food & Drug Administration, Section 2563, Protecting Consumer Access to Generic Drugs HR 3200, Subtitle C, Food & Drug Administration, Part 2, Biosimilars Section 2565, Licensure Pathway for Biosimilar Biological Products HR 1427, the Promoting Innovation and Access to Life Savings Medicine Act HR 1548, Pathway for Biosimilars Act

S. 515, the Patent Reform Act of 2009 concerning inenquitable conduct

S. 369, the Preserve Access to Affordable Pharmaceuticals Act HR 1706, the Protecting Consumer Access to Generic Drugs Act HR 1427, the Promoting Innovation and Access to Life Saving Medicine Act S. 726, the Promoting Innovation and Access to Life Saving Medicine Act HR 1548, Pathway for Biosimilars Act S. 501, the Fair Prescription Drug Competition Act S. 767, the Independent Drug Education and Outreach Act S. 1315, the Price Competition Act of 2009 HR 2997, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2010, Title VI, FDA, concerning funding for the Office of Generic Drugs Electronic labeling for pharmaceuticals

S.. 515, the Patent Reform Act of 2009 concerning inequitable conduct issue

S. 369, the Preserve Access to Affordable Generics Act HR 1706, the Protecting Consumer Access to Generic Drugs Act HR 1427, the Promoting Innovation and Access to Life Saving Medicine Act S. 726, the Promoting Innovation and Access to Life Saving Medicine Act HR 1548, Pathway for Biosimilars Act S. 501, the Fair Prescription Drug Competition Act HR 573 concerning authorized generics

Legislation concerning reimbursement for generic drugs under the Medicaid program

S. 316, the Preserve Access to Affordable Pharmaceuticals Act H.R. 1902, the Protecting Consumer Access to Generic Drugs Act H.R. 1038, the Access to Life Savings Medicine Act H.R. 5629, the Pathway for Biosimilars Act S. 1695, the Biologivs Price Competition and Innovation Act H.R. 5829, the Safeguarding America's Pharmaceuticals Act H.R. 3610, the Food and Drug Import Safety Act, Section 4 User Fees Regarding Drug Safety PL 110-85, the Food and Drug Amendments Act of 2007, Title VIII Clinical Trials Abbreviated New Drug Applicatin No. 76-396 for calcitonin salmon nasal spray

Centers for Medicare and Medicaid Services Rule 2238-P concerning Medicaid Drug Reimbursement H.R. 3700 & S. 1951, the Fair Medicaid Drug Pricing Act

S. 316, the Preserve Access to Affordable Pharmaceuticals Act HR 1902, the Protecting Consumer Access to Generic Drugs Act HR 1038, the Access to Life Savings Medicine Act HR 5629, the Pathway for Biosimilars Act S. 1695, the Biologics Price Competition and Innovation Act HR 5829, the Safeguarding America's Pharmaceuticals Act HR 3610, the Food and Drug Import Safety Act, Section 4 User Fees Regarding Drug Safety PL 110-85, the Foord and Drug Amendments Act of 2007, Section 914, Citizen Petition and petition for stay of agency action PL 110-85, the Food and Drug Amendments Act of 2007. Title VIII, Clinical Trial Databases HR 6432, Animal Drug User Fee Amendments of 2008, Section 301, Consideration of Certain Petitions Combating anti-generic substitution legislation in the states Abbreviated New Drug Application No. 76-396 for calcitonin salmon nasal spray

Centers for Medicare and Medicaid Services Rule 2238-P concerning Medicaid Drug Reimbursement HR 3700 & S 1951, Fair Medicaid Drug Pricing Act

S 316, the Preserve Access to Affordable Generics Act HR 1902, the Protecting Consumer Access to Generic Drugs Act HR 1038, the Access to Life Saving Medicine Act HR 5629, the Pathway for Biosimilars Act S 1695, the Biologics Price Competition and Innovation Act HR 5839, the Safeguarding America's Pharmaceuticals Act HR 3610, the Food and Drug Import Safety Act, Section 4, User Fees Regarding Drug Safety Draft Senate food and drug import safety legislation PL 110-85, the Food and Drug Amendments Act of 2007, Section 914, Citizen Petitions and petitions for stay of agency action Combating anti-generic subsitution legislation in the states

Centers for Medicare and Medicaid Services Rule 2238-P concerning Medicaid prescription drug reimbursement HR 3700 & S 1951, Fair Medicaid Drug Pricing Act HR 3140, Saving Our Community Pharmacy Act HR 6331, S 3101, the Medicare Improvements for Patients and Providers Act of 2008, Section 203, Pharmacy Reimbursement Under Medicaid

S 316, the Preserve Access to Affordable Generics Act HR 1902, the Protecting Consumer Access to Generic Drugs Act HR 1038, the Access to Life Saving Medicine Act HR 5629, the Pathway for Biosimilars Act S 1695, the Biologics Price Competition and Innovation Act HR 5839, the Safeguarding America's Pharmaceuticals Act HR 3610, the Food and Drug Import Safety Act, Section 4, User Fees Regarding Drug Safety Draft Senate food and drug import safety legislation PL 110-85, the Food and Drug Amendments Act of 2007, Section 914, Citizen Petitions and petitions for stay of agency action Combating anti-generic subsitution legislation in the states

S 1145, Patent Reform Act of 2007, Section 12, Inequitable Conduct HR 1908, Patent Reform Act of 2007, Section 12, Additional Information, Inequitable Conduct as a Defense to Infringment

Centers for Medicare and Medicaid Services Rule 2238-P concerning Medicaid prescription drug reimbursement S. 1951, Fair Medicaid Drug Pricing Act HR 3700, Fair Medicaid Drug Pricing Act HR 3140, Saving our Community Pharmacy Act

HR 1908, Patent Reform Act of 2007, Section 12, Additional Information, Inequitable Conduct as a Defense to Infringement S. 1145, Patent Reform Act of 2007, Section 12, Inequitable Conduct

S. 316, the Preserve Access to Affordable Generics Act HR 1902, the Protecting Consumer Access to Generic Drugs Act HR 1432, the Preserve Access to Affordable Generics Act HR 1038, the Access to Life Savings Medicine Act S. 623, the Access to Life Savings Medicine Act S. 1695, the Biologics Price Competition and Innovation Act S. 1088, Lower Priced Drugs Act HR 3610, the Food and Drug Import Safety Act, Section 4, User Fees Regarding Drug Safety Pharmaceutical pedigree/track and trace issues

HR 3161, FY 2008 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations -- Office of Generic Drug Funding S 1859, FY 2008 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations -- Office of Generic Drug Funding HR 2764, Consolidated Appropriations Act of 2008 -- FDA Office of Generic Drug Funding

S. 316, the Preserve Access to Affordable Pharmaceuticals Act HR 1902, Protecting Consumer Access to Generic Drugs Act HR 1038, Access to Life Savings Medicine Act S. 623, Access to Life Savings Medicine Act S 1695, Biologics Price Competition and Innovation Act S 1088, Lower Priced Drugs Act HR 3580, FDA Amendment Act of 2007 Abbreviated New Drug Application No. 76-396 for calcitonin salmon nasal spray HR 3610, the Food and Drug Import Safety Act, Section 4, User Fees Regarding Drug Safety

S. 316, the Preserve Access to Affordable Pharmaceuticals Act HR 1902, Protecting Consumer Access to Generic Drugs Act HR 1038, Access to Life Savings Medicine Act S. 623, Access to Life Savings Medicine Act

HR 3161, FY 2008 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations -- Office of Generic Drug Funding S 1859, FY 2008 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations -- Office of Generic Drug Funding

Centers for Medicare and Medicaid Services Rule 2238-P concerning Medicaid prescription drug reimbursement S. 1951, Fair Medicaid Drug Payment Act HR 3700, Fair Medicaid Drug Payment Act HR 3140, Saving our Community Pharmacy Act

HR 1908, Patent Reform Act of 2007 S. 1145, Patent Reform Act of 2007

Centers for Medicare and Medicaid Services Rule 2238-P concerning Medicaid prescription drug reimbursement

HR 3161, FY 2008 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations -- Office of Generic Drug Funding S 1859, FY 2008 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations -- Office of Generic Drug Funding

See LD-2 Reports

See LD-2 Reports

See LD-2 Reports

See LD-2 Reports

S. 3981, the Citizen Petition Fairness and Accuracy Act Abbreviated New Drug Application No. 76-396 for calcitonin-salmon nasal spray Hatch-Waxman Amendments S. 3582, the Preserve Access to Affordable Generics Act S. 3695, HR. 5993, to prohibit Authorized Generics during 180 day exclusivity HR 6257 & S. 4016, the Access to Life Saving Medicines Act S. 2300 & HR 6022, the Lower Priced Drugs Act

S. 3818, the Patent Reform Act of 2006