Competition Prescription Act of 2019
USA116th CongressHR-3947| House
| Updated: 8/28/2019
Mark Meadows
Republican Representative
North Carolina
Committees (11)
• Administrative State, Regulatory Reform, and Antitrust Subcommittee• Ways and Means Committee• Military Personnel Subcommittee• Health Subcommittee• Health Subcommittee• Courts, Intellectual Property, Artificial Intelligence, and the Internet Subcommittee• Judiciary Committee• Armed Services Committee• Constitution and Limited Government Subcommittee• Energy and Commerce Committee• Oversight and Government Reform Committee
- Introduced
- In Committee
- On Floor
- Passed Chamber
- Enacted
Competition Prescription Act of 2019 This bill revises various requirements related to the development, production, and sale of prescription drugs and biological products. First, the bill permits the developer of a drug or biological product to bring a civil action against the license holder of an approved product if the license holder has declined to make available sufficient quantities of the approved product for the developer's testing. The bill also requires the Food and Drug Administration (FDA) to establish a process for developers of generic complex drugs to request and receive expedited development and priority review. Further, upon request by a drug sponsor, a drug that treats a life-threatening disease or condition must be designated for expedited review if there are fewer than three drugs currently available for such treatment. States are prohibited from placing restrictions on dispensing substitute biological products that have been determined to be interchangeable with another product by the FDA. Additionally, the bill prohibits sponsors of Medicare Part D prescription drug plans from reducing a payment to a pharmacy after a claim without defect has been submitted by such pharmacy. The bill establishes requirements for pricing standards for pharmacy benefits managers under Medicare and other federal prescription drug benefits programs. Starting in 2025, the bill removes the cap on rebates paid by manufacturers of outpatient prescription drugs under Medicaid. Further, the bill requires the publication of specified information regarding licensed biological products, exempts from antitrust prohibitions specified drug-price negotiation strategies, and establishes a Chief Pharmaceutical Negotiator in the Office of the U.S. Trade Representative.
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Timeline
Introduced in House
Referred to the Subcommittee on Health.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Military Personnel.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Referred to the Subcommittee on the Constitution, Civil Rights, and Civil Liberties.
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
Health
Administrative law and regulatory proceduresAdministrative remediesCivil actions and liabilityCompetition and antitrustConsumer affairsContracts and agencyDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationEmployee benefits and pensionsFederal district courtsFederal preemptionGovernment employee pay, benefits, personnel managementGovernment information and archivesHealth care costs and insuranceHealth information and medical recordsHealth technology, devices, suppliesInflation and pricesInsurance industry and regulationLicensing and registrationsMedicaidMedical ethicsMedical researchMedicareMilitary medicinePrescription drugsProduct development and innovationResearch and developmentRetail and wholesale tradesRight of privacy
Competition Prescription Act of 2019
USA116th CongressHR-3947| House
| Updated: 8/28/2019
Competition Prescription Act of 2019 This bill revises various requirements related to the development, production, and sale of prescription drugs and biological products. First, the bill permits the developer of a drug or biological product to bring a civil action against the license holder of an approved product if the license holder has declined to make available sufficient quantities of the approved product for the developer's testing. The bill also requires the Food and Drug Administration (FDA) to establish a process for developers of generic complex drugs to request and receive expedited development and priority review. Further, upon request by a drug sponsor, a drug that treats a life-threatening disease or condition must be designated for expedited review if there are fewer than three drugs currently available for such treatment. States are prohibited from placing restrictions on dispensing substitute biological products that have been determined to be interchangeable with another product by the FDA. Additionally, the bill prohibits sponsors of Medicare Part D prescription drug plans from reducing a payment to a pharmacy after a claim without defect has been submitted by such pharmacy. The bill establishes requirements for pricing standards for pharmacy benefits managers under Medicare and other federal prescription drug benefits programs. Starting in 2025, the bill removes the cap on rebates paid by manufacturers of outpatient prescription drugs under Medicaid. Further, the bill requires the publication of specified information regarding licensed biological products, exempts from antitrust prohibitions specified drug-price negotiation strategies, and establishes a Chief Pharmaceutical Negotiator in the Office of the U.S. Trade Representative.
View Full TextSuggested Questions
Get AI-generated questions to help you understand this bill better
Timeline
Introduced in House
Referred to the Subcommittee on Health.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Military Personnel.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Referred to the Subcommittee on the Constitution, Civil Rights, and Civil Liberties.
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
Mark Meadows
Republican Representative
North Carolina
Committees (11)
• Administrative State, Regulatory Reform, and Antitrust Subcommittee• Ways and Means Committee• Military Personnel Subcommittee• Health Subcommittee• Health Subcommittee• Courts, Intellectual Property, Artificial Intelligence, and the Internet Subcommittee• Judiciary Committee• Armed Services Committee• Constitution and Limited Government Subcommittee• Energy and Commerce Committee• Oversight and Government Reform Committee
Health
Related Bills
- Introduced
- In Committee
- On Floor
- Passed Chamber
- Enacted
Administrative law and regulatory proceduresAdministrative remediesCivil actions and liabilityCompetition and antitrustConsumer affairsContracts and agencyDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationEmployee benefits and pensionsFederal district courtsFederal preemptionGovernment employee pay, benefits, personnel managementGovernment information and archivesHealth care costs and insuranceHealth information and medical recordsHealth technology, devices, suppliesInflation and pricesInsurance industry and regulationLicensing and registrationsMedicaidMedical ethicsMedical researchMedicareMilitary medicinePrescription drugsProduct development and innovationResearch and developmentRetail and wholesale tradesRight of privacy