Recall Unsafe Drugs Act of 2020

Opioids; CREATES Act; Drug Pricing HR 4712 (116th Congress), Fairness in Orphan Drug Exclusivity Act, by Rep. Madeleine Dean (D-PA). Amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs. HR 5578 (116th Congress), Recall Unsafe Drugs Act of 2020, by Rep. Rosa DeLauro (D-CT). Provide for the mandatory recall of drugs regulated by the Food and Drug Administration. HR 5663 (116th Congress), Safeguarding Therapeutics Act, by Rep. Brett Guthrie (R-KY). Give authority to the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to destroy counterfeit devices. HR 5691 (116th Congress), Insulin Affordability Data Collection Act, by Rep. Angie Craig (D-MN). Require the Secretary to conduct a study and issue a report on the affordability of insulin. HR 5749 (116th Congress), Affordable Insulin for All Act, by Rep. Charlie Crist (D-FL). Establish the American Insulin Program to provide for lower prices for insulin drugs, to maintain effort throughout the insulin supply chain. HR 5894 (116th Congress), Transparency in Prescription Drug Advertising Act, by Rep. Sharice Davids (D-KS). Directs the Secretary of Health and Human Services to issue guidance requiring the list prices of drugs to be included in advertisements for such drugs. HR 5927 (116th Congress), Safe Medicine Act, by Rep. Bill Posey (R-FL). Directs the Secretary of Health and Human Services to study American dependence on unsafe Chinese pharmaceuticals and to empower the Food and Drug Administration to mandate drug recalls in the case of critical contamination. HR 5982 (116th Congress), Safe Medicine Act, by Rep. Bill Posey (R-FL). Directs the Secretary of Health and Human Services to study American dependence on Chinese pharmaceuticals and to empower the Food and Drug Administration to issue boxed warnings in the case of critical contamination. HR 6193 (116th Congress), Medication Access in Emergencies Act of 2020, by Rep. Chris Pappas (D-NH). Require group health plans and health insurance issuers offering group or individual health insurance coverage to provide benefits under such plan or such coverage for a 30-day refill of prescription drugs to individuals who reside in emergency areas during emergency periods. HR 6731 (116th Congress), Securing Americas Pharmaceutical Supply Chain Act, by Rep. Pete Stauber (R-MN). Require executive agencies to purchase pharmaceuticals from the United States.

Client expense: $350,000 · Firm income: Not reported

Government targets: Centers For Medicare and Medicaid Services (CMS), Executive Office of the President (EOP), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Labor, Dept of (DOL), Office of Management & Budget (OMB), SENATE, White House Office

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.

Opioids (Epidemic, Deterrence, Economic Impact Zones); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs Rx Rebates; Biosimilars; Drug approval; Drug patents, generic drugs, Part D Reform, Biosimilars, Civica Rx H.R.1781 - 116th Congress (2019-2020) Payment Commission Data Act of 2019 Sponsor: Rep. Carter, Earl L. "Buddy" [R-GA-1] H.R.938 - 116th Congress (2019-2020) BLOCKING Act of 2019 Sponsor: Rep. Schrader, Kurt [D-OR-5] H.R.1520 - 116th Congress (2019-2020) Purple Book Continuity Act of 2019 Sponsor: Rep. Eshoo, Anna G. [D-CA-18] H.R.1503 - 116th Congress (2019-2020) Orange Book Transparency Act of 2019 Sponsor: Rep. Kelly, Robin L. [D-IL-2] H.R.1499 - 116th Congress (2019-2020) Protecting Consumer Access to Generic Drugs Act of 2019 Sponsor: Rep. Rush, Bobby L. [D-IL-1] H.R.965 - 116th Congress (2019-2020) CREATES Act of 2019 Sponsor: Rep. Cicilline, David N. [D-RI-1] H.R.3 - 116th Congress (2019-2020) Lower Drug Costs Now Act of 2019 Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6] H.R.275 - 116th Congress (2019-2020) Medicare Prescription Drug Price Negotiation Act of 2019 Sponsor: Rep. Welch, Peter [D-VT-At Large] H.R.448 - 116th Congress (2019-2020) Medicare Drug Price Negotiation Act Sponsor: Rep. Cummings, Elijah E. [D-MD-7] H.R.1046 - 116th Congress (2019-2020) Medicare Negotiation and Competitive Licensing Act of 2019 Sponsor: Rep. Doggett, Lloyd [D-TX-35] S. 3092 -- 116th Congress (2019-2020) Expanding Access to Low-Cost Generics Act of 2019 Sponsor: Sen. Tina Smith (D-MN) S. 2546 - 116th Congress (2019-2020) Safe Step Act Sen. Lisa Murkowski (R-AK) S. 3374 - 116th Congress - Second Session Protecting Jessica Grubb's Legacy Act Sen. Joe Manchin (D-WV) H.R. 19 - 116th Congress - First Session Lower Costs, More Cures Act of 2019 Rep. Greg Walden (R-OR-02) H.R. 6193 - 116th Congress - Second Session Medication Access in Emergencies Act of 2020 Rep. Chris Pappas (D-NH-01) H.R. 5578 - 116th Congress - Second Session Recall Unsafe Drugs Act of 2020 Rep. Rosa DeLauro (D-CT-03) H.R. 5691 - 116th Congress - Second Session Insulin Affordability Data Collection Act H.R. 5894 - 116th Congress - Second Session Transparency in Prescription Drug Advertising Act Rep. Sharice Davids (D-KS-03) H.R. 5927 - 116th Congress - Second Session Safe Medicine Act Rep. Bill Posey (R-FL-08) H.R. 5663 - 116th Congress - Second Session Safeguarding Therapeutics Act Rep. Brett Guthrie (R-KY-02) R. 4712 - 116th Congress - First Session Fairness in Orphan Drug Exclusivity Act Rep. Madeleine Dean (D-PA-04) H.R. 2477 - 116th Congress - First Session Beneficiary Enrollment Notification and Eligibility Simplification Act of 2019 Rep. Raul Ruiz (D-CA-36)

Opioids (Epidemic, Deterrence, Economic Impact Zones); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs; Rx Rebates; Biosimilars; Drug Approval; Drug Patents; Generic Drugs; Part D Reform, Civica Rx HR 3 (116th Congress), Lower Drug Costs Now Act of 2019, by Rep. Frank Pallone, Jr. (D-NJ). To establish a fair price negotiation program, protect the Medicare program from excessive price increases, and establish an out-of-pocket maximum for Medicare part D enrollees, and for other purposes. HR 19 (116th Congress), Lower Costs, More Cures Act of 2019, by Rep. Greg Walden (R-OR). To provide for certain reforms with respect to the Medicare program under title XVIII of the Social Security Act, the Medicaid program under title XIX of such Act, the Food and Drug Administration, and for other purposes. HR 275 (116th Congress), Medicare Prescription Drug Price Negotiation Act of 2019, by Rep. Peter Welch (D-VT). To amend part D of title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate covered part D drug prices on behalf of Medicare beneficiaries. HR 448 (116th Congress), Medicare Drug Price Negotiation Act, by Rep. Elijah Cummings (D-MD). To amend title XVIII of the Social Security Act to provide for the negotiation of lower covered part D drug prices on behalf of Medicare beneficiaries and the establishment and application of a formulary by the Secretary of Health and Human Services under Medicare part D, and for other purposes. HR 938 (116th Congress), Bringing Low-cost Options and Competition while Keeping Incentives for New Generics Act of 2019 (the BLOCKING Act) of 2019, by Rep. Kurt Schrader (D-OR). To amend the Federal Food, Drug, and Cosmetic Act, with respect to eligibility for approval of a subsequent generic drug, to remove the barrier to that approval posed by the 180-day exclusivity period afforded to a first generic applicant that has not yet received final approval, and for other purposes. HR 965 (116th Congress), CREATES Act of 2019, by Rep. David Cicilline (D-RI). To promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products. HR 1046 (116th Congress), Medicare Negotiation and Competitive Licensing Act of 2019, by Rep. Lloyd Doggett (D-TX). To amend title XVIII of the Social Security Act to require the Secretary of Health and Human Services to negotiate prices of prescription drugs furnished under part D of the Medicare program. HR 1499 (116th Congress), Protecting Consumer Access to Generic Drugs Act of 2019, by Rep. Bobby Rush (D-IL). To prohibit brand name drug manufacturers from compensating generic drug manufacturers to delay the entry of a generic drug into the market, and to prohibit biological product manufacturers from compensating biosimilar and interchangeable product manufacturers to delay entry of biosimilar and interchangeable products, and for other purposes. HR 1503 (116th Congress), Orange Book Transparency Act of 2019, by Rep. Robin Kelly (D-IL). To amend the Federal Food, Drug, and Cosmetic Act regarding the list under section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act, and for other purposes. HR 1520 (116th Congress), Purple Book Continuity Act of 2019, by Rep. Anna Eshoo (D-CA). To amend the Public Health Service Act to provide for the publication of a list of licensed biological products, and for other purposes. HR 1781 (116th Congress), Payment Commission Data Act of 2019, by Rep. Earl Carter (D-GA). To amend titles XVIII and XIX of the Social Security Act to provide the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with access to certain drug payment information, including certain rebate information. HR 4712 (116th Congress), Fairness in Orphan Drug Exclusivity Act, by Rep. Madeleine Dean (D-PA). To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes. HR 5578 (116th Congress), Recall Unsafe Drugs Act of 2020, by Rep. Rosa DeLauro (D-CT). To provide for the mandatory recall of drugs regulated by the Food and Drug Administration. HR 5663 (116th Congress), Safeguarding Therapeutics Act, by Rep. Brett Guthrie (R-KY). To amend the Federal Food, Drug, and Cosmetic Act to give authority to the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to destroy counterfeit devices. HR 5691 (116th Congress), Insulin Affordability Data Collection Act, by Rep. Angie Craig (D-MN). To require the Secretary to conduct a study and issue a report on the affordability of insulin. HR 5894 (116th Congress), Transparency in Prescription Drug Advertising Act, by Rep. Sharice Davids (D-KS). To direct the Secretary of Health and Human Services to issue guidance requiring the list prices of drugs to be included in advertisements for such drugs. HR 5927 (116th Congress), Safe Medicine Act, by Rep. Bill Posey (R-FL). To direct the Secretary of Health and Human Services to study American dependence on unsafe Chinese pharmaceuticals and to empower the Food and Drug Administration to mandate drug recalls in the case of critical contamination. HR 6193 (116th Congress), Medication Access in Emergencies Act of 2020, by Rep. Chris Pappas (D-NH). To amend title XXVII of the Public Health Service Act to require group health plans and health insurance issuers offering group or individual health insurance coverage to provide benefits under such plan or such coverage for a 30-day refill of prescription drugs to individuals who reside in emergency areas during emergency periods. S 2546 (116th Congress), Safe Step Act, by Sen. Lisa Murkowski (R-AK). To amend the Employee Retirement Income Security Act of 1974 to require a group health plan or health insurance coverage offered in connection with such a plan to provide an exceptions process for any medication step therapy protocol, and for other purposes. S 3092 (116th Congress), Expanding Access to Low-Cost Generics Act of 2019, by Sen. Tina Smith (D-MN). To amend the Federal Food, Drug, and Cosmetic Act with respect to the 180-day exclusivity period, and for other purposes.

Opioids (Epidemic, Deterrence, Economic Impact Zones); CREATES Act; Drug Pricing; PBM/Prescription Drug Costs Rx Rebates; Rx Rebates; Biosimilars; Drug approval; Drug patents, generic drugs, Part D Reform; Civica Rx H.R.1499 - 116th Congress (2019-2020) Protecting Consumer Access to Generic Drugs Act of 2019 Sponsor: Rep. Rush, Bobby [D-IL-1](Introduced 03/08/2019) H.R.965 - 116th Congress (2019-2020) CREATES Act of 2019 Sponsor: Rep. Cicilline, David [D-RI-1](Introduced 02/05/2019) H.R.3 - 116th Congress (2019-2020) Lower Drug Costs Now Act of 2019 Sponsor: Rep. Pallone, Frank, Jr. [D-NJ-6](Introduced 09/19/2019) H.R.275 - 116th Congress (2019-2020) Medicare Prescription Drug Price Negotiation Action of 2019 Sponsor: Rep. Welch, Peter [D-VT-At Large](Introduced 01/08/2019) H.R.448 - 116th Congress (2019-2020) Medicare Drug Price Negotiation Act Sponsor: Rep. Cummings, Elijah E. [D-MD-7](Introduced 01/10/2019) H.R.1046 - 116th Congress (2019-2020) Medicare Negotiation and Competitive Licensing Act of 2019 Sponsor: Rep. Doggett, Lloyd [D-TX-35](Introduced 02/07/2019) S.3092 - 116th Congress (2019-2020) Expanding Access to Low-Cost Generics Act of 2019 Sponsor: Sen. Smith, Tina [D-MN](Introduced 12/18/2019) H.R.19 - 116th Congress (2019-2020) Lower Costs, More Cures Act of 2019 Sponsor: Rep. Walden, Gred [R-OR-2](Introduced 12/09/2019) H.R.6193 - 116th Congress (2019-2020) Medication Access in Emergencies Act of 2020 Sponsor: Rep Pappas, Chris [D-NH-1](Introduced 03/11/2020) H.R.5578 - 116th Congress (2019-2020) Recall Unsafe Drugs Act of 2020 Sponsor: Rep. Delauro, Rosa [D-CT-3](Introduced 01/10/2020) H.R.5691 - 116th Congress (2019-2020) Insulin Affordability Data Collection Act Sponsor: Rep. Craig, Angie [D-MN-2](Introduced 01/28/2020) H.R.5894 - 116th Congress (2019-2020) Transparency in Prescription Drug Advertising Act Sponsor: Rep Davids, Sharice [D-KS-3](Introduced 02/13/2020)