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Fairness in Orphan Drug Exclusivity Act
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Fairness in Orphan Drug Exclusivity Act This bill limits which orphan drugs may be granted a market exclusivity period by the Food and Drug Administration (FDA). (Generally, an orphan drug is one that is not economically viable because of the rarity of the disease that it treats; the sponsor of an FDA-designated orphan drug may be granted various incentives, such as a seven-year period in which the FDA may not grant market approval to a different sponsor for the same drug to treat the same disease.) Specifically, when determining whether to grant an exclusivity period to a drug that has orphan status due to low expected sales, the FDA must consider the sales of all drugs from the sponsor that are covered by the same orphan drug designation.
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)
2020 · fourth_quarter · Health Issues
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Bills with similar content found using semantic analysis.
Sources: Congress.gov
DEA implementation of the SECURE Act and specifically Section 3204 addressing specialty pharmacy delivery providerS of long-acting injectable buprenorphine products. Fairness in Orphan Drug Exclusivity Act, H.R. 4712/S. 3271, included in H.R. 133, Consolidated Appropriations Act of 2021, PL 116-196).
Client expense: Not reported · Firm income: $40,000
Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Justice, Dept of (DOJ), SENATE
2020 · fourth_quarter · Health Issues
Rare disease patient care, screening, and coverage issues in authorization and appropriations legislation; Orphan Drug Act; H.R. 2507, S. 2158 Newborn Screening Saves Lives Act Reauthorization; FY 2021 CDC Appropriations; HR 4144, Ending the Diagnostic Odyssey Act; H.R. 5062, Advancing Access to Precision Medicine Act; H.R. 4712, S. 3271 Fairness in Orphan Drug Exclusivity Act; H.R. 534, Aidan's Law; HR 6238, Cameron's Law; rare kidney disease issues; HR 133, Consolidated Appropriations Act of 2021
Client expense: $150,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · fourth_quarter · Health Issues
Expand access to treatment for persons with opioid use disorder. HR 4712 / S 3271, Fairness in Orphan Drug Exclusivity Act. HR 1329, the Medicaid Reentry Act. HR 1865 / HR 2740, FY21 Labor-HHS-Education Appropriations Act. HR 3055, FY21 Commerce-Justice-Science Appropriations Act. HR 4378 / HR 3055, FY21 Continuing Resolution Appropriations Act. HR 133 Omnibus FY21 Appropriations and COVID Relief
Client expense: Not reported · Firm income: $20,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Pharmacy
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Insurance
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Alcohol and Drug Abuse
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Medicare/Medicaid
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · fourth_quarter · Health Issues
reducing stigma and promoting treatment of opioid use disorder raising awareness of the benefits of medication assisted therapy (MAT) ensuring patient access to MAT FDA approval and exclusivity process HR 4712 Fairness in Orphan Drug Exclusivity Act S 3271 Fairness in Orphan Drug Exclusivity Act patient access to practitioner-administered therapies
Client expense: Not reported · Firm income: $50,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2020 · third_quarter · Health Issues
DEA implementation of the SECURE Act and specifically Section 3204 addressing specialty pharmacy delivery to the provider of long-acting injectable buprenorphine products. Fairness in Orphan Drug Exclusivity Act, H.R. 4712/S. 3271.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
Rare disease patient care, screening, and coverage issues in authorization and appropriations legislation; Orphan Drug Act; H.R. 2507, S. 2158 Newborn Screening Saves Lives Act Reauthorization; FY 2021 CDC Appropriations; HR 4144, Ending the Diagnostic Odyssey Act; H.R. 5062, Advancing Access to Precision Medicine Act; H.R. 4712, S. 3271 Fairness in Orphan Drug Exclusivity Act; H.R. 534, Aidan's Law; HR 6238, Cameron's Law; rare kidney disease issues
Client expense: $170,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · third_quarter · Pharmacy
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $120,000 · Firm income: Not reported
Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE
2020 · third_quarter · Insurance
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $120,000 · Firm income: Not reported
Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE
2020 · third_quarter · Health Issues
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $120,000 · Firm income: Not reported
Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE
2020 · third_quarter · Medicare/Medicaid
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $120,000 · Firm income: Not reported
Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE
2020 · third_quarter · Alcohol and Drug Abuse
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act; Administration of controlled substances by HCPs; Storage of controlled substances
Client expense: $120,000 · Firm income: Not reported
Government targets: Drug Enforcement Administration (DEA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Justice, Dept of (DOJ), SENATE
2020 · third_quarter · Health Issues
Expand access to treatment for persons with opioid use disorder. HR 4712 / S 3271, Fairness in Orphan Drug Exclusivity Act. HR 1329, the Medicaid Reentry Act. HR 6800 /HR 925 as amended, HEROES Act. HR 1865 / HR 2740, FY21 Labor-HHS-Education Appropriations Act, HR 3055, FY21 Commerce-Justice-Science Appropriations Act. HR 4378 / HR 3055, FY21 Continuing Resolution Appropriations Act.
Client expense: Not reported · Firm income: $20,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · third_quarter · Health Issues
reducing stigma and promoting treatment of opioid use disorder raising awareness of the benefits of medication assisted therapy (MAT) ensuring patient access to MAT FDA approval and exclusivity process HR 4712 Fairness in Orphan Drug Exclusivity Act S 3271 Fairness in Orphan Drug Exclusivity Act patient access to practitioner-administered therapies
Client expense: Not reported · Firm income: $50,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2020 · second_quarter · Health Issues
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE
2020 · second_quarter · Alcohol and Drug Abuse
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE
2020 · second_quarter · Pharmacy
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE
2020 · second_quarter · Insurance
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE
2020 · second_quarter · Medicare/Medicaid
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, Office of Natl Drug Control Policy (NDCP), SENATE
2020 · second_quarter · Health Issues
Expand access to treatment for persons with opioid use disorder. HR 4712 / S 3271, Fairness in Orphan Drug Exclusivity Act. HR 1329, the Medicaid Reentry Act. FY21 Labor-HHS-Education Appropriations Act, FY21 Commerce-Justice-Science Appropriations Act.
Client expense: Not reported · Firm income: $10,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Health Issues
DEA implementation of the SECURE Act and specifically Section 3204 addressing specialty pharmacy delivery to the provider of long-acting injectable buprenorphine products. Fairness in Orphan Drug Exclusivity Act, H.R. 4712/S. 3271.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · second_quarter · Health Issues
reducing stigma and promoting treatment of opioid use disorder raising awareness of the benefits of medication assisted therapy (MAT) ensuring patient access to MAT FDA approval and exclusivity process HR 4712 Fairness in Orphan Drug Exclusivity Act S 3271 Fairness in Orphan Drug Exclusivity Act patient access to practitioner-administered therapies
Client expense: Not reported · Firm income: $50,000
Government targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Natl Drug Control Policy (NDCP), SENATE, Substance Abuse & Mental Health Services Administration (SAMHSA), White House Office
2020 · second_quarter · Health Issues
Rare disease patient care, screening, and coverage issues in authorization and appropriations legislation; Orphan Drug Act; H.R. 2507, S. 2158 Newborn Screening Saves Lives Act Reauthorization; FY 2021 CDC Appropriations; HR 4144, Ending the Diagnostic Odyssey Act; H.R. 5062, Advancing Access to Precision Medicine Act; H.R. 4712, S. 3271 Fairness in Orphan Drug Exclusivity Act; H.R. 534, Aidan's Law; issues related kidney care
Client expense: $150,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · first_quarter · Health Issues
Preserve Access to Affordable Generics Act (S. 64); Regulatory exclusivity; Drug pricing; Medicare Part B international reference pricing; Protecting Consumer Access to Generic Drugs Act of 2019 (H.R. 1499); Generic drug competition; Drug patent issues; Proposed rule on rebate safe Harbor (84 Fed. Reg. 2340); Lower Health Care Costs Act of 2019 (S. 1895); STOP Stalling Act (S. 1224); Affordable Prescriptions for Patients Act of 2019 (S. 1416); Preserve Access to Affordable Generics and Biosimilars Act (H.R.2375); Drug importation; State-Based, Market-Oriented, Prescription Drug Negotiations Act of 2019 (H.R. 2038); Transparent Drug Pricing Act of 2019 (S.977); Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2019 (S. 2161); Medicare Negotiation and Competitive Licensing Act of 2019 (H.R. 1046); Direct to consumer advertising; Medicare Prescription Drug Price Negotiation Act of 2019 (H.R. 275); Medicare Drug Price Negotiation Act (H.R. 448); Lower Drug Costs Now Act of 2019 (H.R. 3); Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019 (S.476); Fair Care Act of 2019 (H.R.1332); Prescription Drug Pricing Reduction Act of 2019 (S. 2543); Competition Prescription Act of 2019 (H.R. 3947); Fixing Global Freeloading Act (H.R. 2209); Affordable Prescriptions for Patients Through Promoting Competition Act of 2019 (HR 5133/HR 4398); STOP GAMES Act of 2019 (HR 2387);; H.R.3666 - STRONGER Patents Act of 2019, H.R.19 - Lower Costs, More Cures Act of 2019, Pharmaceutical Independence Long-Term Readiness Reform Act (HR 4710); H.R. 3991 - Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019; Purple Book Continuity Act of 2019 (H.R. 1520); Biologic Patent Transparency Act (S. 659); Conditional Approval Act (S. 3133); Fairness in Orphan Drug Exclusivity Act (H.R. 4712 / S. 3271); Orange Book Transparency Act of 2019 (H.R. 1503); Prescription Drug Affordability and Access Act (S. 3166); Biosimilars user fees legislation; Lowering Prescription Drug Prices for Americas Seniors and Families Act (S. 3384); Anticompetitive Exclusionary Conduct Prevention Act of 2020 (S. 3426); Second Look at Drug Patents Act of 2019 (S. 1617); Priority review vouchers; MODERN Labeling Act of 2020 (HR 5668); CARES Act (HR 748/S. 3548); Recall Unsafe Drugs Act of 2020 (HR 5578); Buy American Executive Order; Compulsory licensing; Strengthening Innovation in Medicare and Medicaid Act (H.R. 5741), No Ban Act (H.R. 2214/S. 1123); Benefit and Payment Parameters; Notice Requirement for Non-Federal Governmental Plans (85 Fed. Reg. 7088); Mitigating Emergency Drug Shortages Act (MEDS Act) (S. 2723); Medical Supply Chain Security Act (S. 3343); Strengthening America's Supply Chain and National Security Act (S. 3538) Families First Coronavirus Response Act (H.R. 6201), Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (H.R. 6074), Drug recalls, registration and listing, shortages, and supply chain reporting; Strategic National Stockpile.
2020 · first_quarter · Health Issues
Rare disease patient care, screening, and coverage issues in authorization and appropriations legislation; Orphan Drug Act; H.R. 2507, S. 2158 Newborn Screening Saves Lives Act Reauthorization; FY 2022 CDC Appropriations; HR 4144, Ending the Diagnostic Odyssey Act; H.R. 5062, Advancing Access to Precision Medicine Act; H.R. 4712, S. 3271 Fairness in Orphan Drug Exclusivity Act; H.R. 534, Aidan's Law
Client expense: $360,000 · Firm income: Not reported
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
2020 · first_quarter · Health Issues
DEA implementation of the SECURE Act and specifically Section 3204 addressing specialty pharmacy delivery to the provider of long-acting injectable buprenorphine products. Fairness in Orphan Drug Exclusivity Act, H.R. 4712/S. 3271.
Client expense: Not reported · Firm income: $40,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · first_quarter · Health Issues
Expand access to treatment for persons with opioid use disorder. HR 4712 / S 3271, Fairness in Orphan Drug Exclusivity Act.
Client expense: Not reported · Firm income: $10,000
Government targets: Centers For Medicare and Medicaid Services (CMS), HOUSE OF REPRESENTATIVES, SENATE
2020 · first_quarter · Pharmacy
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · first_quarter · Health Issues
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · first_quarter · Alcohol and Drug Abuse
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · first_quarter · Insurance
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
2020 · first_quarter · Medicare/Medicaid
HR 4712, S3271 Fairness in Orphan Drug Exclusivity Act: General lobbying pertaining to opioid crisis; controlled substances and specialty pharmacies
Client expense: $100,000 · Firm income: Not reported
Government targets: HOUSE OF REPRESENTATIVES, SENATE
Client expense: Not reported · Firm income: $260,000
Government targets: HOUSE OF REPRESENTATIVES, SENATE, U.S. Trade Representative (USTR)