CRS Products

50 Congressional Research Service reports and publications

Expiring Health Provisions of the 119th Congress
2025-09-24 · Reports · R48649 · HTML available · PDF available
Pharmaceutical Patent Disputes: Generic Entry for Small-Molecule Drugs Under the Hatch-Waxman Act
2025-06-12 · Resources · IF13028 · HTML available · PDF available
Pharmaceutical Patent Disputes: Biosimilar Entry Under the Biologics Price Competition and Innovation Act (BPCIA)
2025-06-12 · Resources · IF13029 · HTML available · PDF available
Most-Favored-Nation Prescription Drug Pricing Executive Order: Legal Issues
2025-06-05 · Posts · LSB11319 · HTML available · PDF available
Connecting Older Adults to Information on Benefits and Services
2025-06-03 · Reports · R47605 · HTML available · PDF available
U.S. Health Care Coverage and Spending
2025-02-19 · Resources · IF10830 · HTML available · PDF available
Medicare Part D Premium Stabilization Demonstration
2025-01-30 · Resources · IF12889 · HTML available · PDF available
“Skinny Labels” for Generic Drugs Under Hatch-Waxman
2024-12-27 · Resources · IF12700 · HTML available · PDF available
Administrative Procedure Act (APA) Challenges to the Medicare Drug Price Negotiation Program
2024-11-14 · Reports · R48264 · HTML available · PDF available
Federal Support for Organ Transplantation: Frequently Asked Questions
2024-11-08 · Reports · R48257 · HTML available · PDF available
Novel Gene Therapies for Blood Disorders
2024-10-25 · Resources · IF12796 · HTML available · PDF available
Constitutional Challenges to the Medicare Drug Price Negotiation Program
2024-10-10 · Reports · R47682 · HTML available · PDF available
Medicare Coverage of GLP-1 Drugs
2024-09-09 · Resources · IF12758 · HTML available · PDF available
State Regulation of Prescription Drug Prices: Prescription Drug Affordability Boards and Related Litigation
2024-09-04 · Posts · LSB11221 · HTML available · PDF available
Consolidated Appropriations Act, 2024 (P.L. 118-42): Medicaid and Medicare Provisions
2024-05-24 · Reports · R48075 · HTML available · PDF available
Litigation Continues Over Use of Contract Pharmacies in 340B Drug Discount Program
2024-05-23 · Posts · LSB11163 · HTML available · PDF available
Vanda Pharmaceuticals, Inc. v. United States: Fifth Amendment Takings Claims for Alleged Disclosures of Trade Secrets and Confidential Information
2024-04-08 · Posts · LSB11143 · HTML available · PDF available
Prescription Drug Importation
2024-01-22 · Resources · IF11056 · HTML available · PDF available
Pharmacy Benefit Managers: Current Legal Framework
2023-11-20 · Posts · LSB11080 · HTML available · PDF available
Medicare Part D Prescription Drug Benefit
2023-11-14 · Reports · R40611 · HTML available · PDF available
Medical Product Regulation: Drugs, Biologics, and Devices
2023-05-26 · Resources · IF11083 · HTML available · PDF available
Implementation of the Medicare Drug Price Negotiation Program: Centers for Medicare and Medicaid Guidance and Legal Considerations
2023-05-16 · Reports · R47555 · HTML available · PDF available
Insulin Coverage Under Private Health Insurance and Medicare Part D: In Brief
2023-02-06 · Reports · R47409 · HTML available · PDF available
Health Care Provisions of the Budget Reconciliation Measure P.L. 117-169
2023-01-24 · Reports · R47396 · HTML available · PDF available
Overview of the 340B Drug Discount Program
2022-10-14 · Resources · IF12232 · HTML available · PDF available
Courts Evaluate the Role of Contract Pharmacies in the 340B Drug Discount Program
2022-10-13 · Posts · LSB10842 · HTML available · PDF available
Supreme Court Overturns HHS Regulation Reducing the Medicare Outpatient Drug Reimbursement Rate for 340B Hospitals
2022-09-16 · Posts · LSB10821 · HTML available · PDF available
Prescription Drug Discount Coupons and Patient Assistance Programs (PAPs)
2022-09-12 · Reports · R44264 · HTML available · PDF available
Selected Health Provisions of the Inflation Reduction Act
2022-09-01 · Resources · IF12203 · HTML available · PDF available
Negotiation of Drug Prices in Medicare Part D
2022-05-23 · Resources · IF11318 · HTML available
Build Back Better Act (BBBA) Health Coverage Provisions: House-Passed and SenateReleased Language
2022-03-30 · Reports · R47056 · HTML available · PDF available
Frequently Asked Questions About Prescription Drug Pricing and Policy
2021-05-06 · Reports · R44832 · HTML available · PDF available
Expanded Access and Right to Try: Access to Investigational Drugs
2021-03-16 · Reports · R45414 · HTML available · PDF available
Off-Label Use of Prescription Drugs
2021-02-23 · Reports · R45792 · HTML available · PDF available
FDA’s Role in the Medical Product Supply Chain and Considerations During COVID-19
2020-09-01 · Reports · R46507 · HTML available · PDF available
Development and Regulation of Medical Countermeasures for COVID-19 (Vaccines, Diagnostics, and Treatments): Frequently Asked Questions
2020-06-25 · Reports · R46427 · HTML available · PDF available
Pharmaceutical Patenting Practices: A Legal Overview
2020-06-01 · Resources · IF11561 · HTML available · PDF available
Drug Price Disclosure to Consumers: Current Legal Authority and Considerations for Congress
2019-07-09 · Posts · LSB10323 · HTML available · PDF available
Biologics and Biosimilars: Background and Key Issues
2019-06-06 · Reports · R44620 · HTML available · PDF available
The Pharmaceutical Drug Development Process
2019-05-29 · Infographics · IG10013 · HTML available
Drug Pricing and the Law: Regulatory Exclusivities
2019-05-17 · Resources · IF11217 · HTML available · PDF available
FDA and Drug Prices: Facilitating Access to Generic Drugs
2019-01-17 · Resources · IF11075 · HTML available · PDF available
The SUPPORT for Patients and Communities Act (P.L.115-271): Medicare Provisions
2019-01-02 · Reports · R45449 · HTML available · PDF available
Drug Shortages: Causes, FDA Authority, and Policy Options
2018-12-27 · Resources · IF11058 · HTML available · PDF available
The SUPPORT for Patients and Communities Act (P.L. 115-271): Food and Drug Administration and Controlled Substance Provisions
2018-11-15 · Reports · R45405 · HTML available · PDF available
How FDA Approves Drugs and Regulates Their Safety and Effectiveness
2018-05-08 · Reports · R41983 · HTML available · PDF available
Prescription Drug User Fee Act (PDUFA): 2017 Reauthorization as PDUFA VI
2018-03-16 · Reports · R44864 · HTML available · PDF available
FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development
2018-03-16 · Reports · R44810 · HTML available · PDF available
Specialty Drugs: Background and Policy Concerns
2015-08-03 · Reports · R44132 · HTML available
Medicaid Prescription Drug Pricing and Policy
2014-11-07 · Reports · R43778 · HTML available