Competition Prescription Act of 2019
Official title: To lower the cost of prescription drugs, and for other purposes.
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Referred to the Subcommittee on the Constitution, Civil Rights, and Civil Liberties.
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.
- Introduced in House Formatted Text PDF Formatted XML
- Administrative State, Regulatory Reform, and Antitrust Subcommittee
- Armed Services Committee
- Constitution and Limited Government Subcommittee
- Courts, Intellectual Property, Artificial Intelligence, and the Internet Subcommittee
- Energy and Commerce Committee
- Health Subcommittee
- Health Subcommittee
- Judiciary Committee
- Military Personnel Subcommittee
- Oversight and Government Reform Committee
- Ways and Means Committee
Cite this page
U.S. Congress. (2026). H.R. 3947: Competition Prescription Act of 2019. 116th Congress. Open America. https://openamerica.io/bill/116-HR-3947/
"H.R. 3947: Competition Prescription Act of 2019." 116th Congress, 2026, Open America, https://openamerica.io/bill/116-HR-3947/.
H.R. 3947, 116th Cong. (2026), https://openamerica.io/bill/116-HR-3947/.
[H.R. 3947: Competition Prescription Act of 2019](https://openamerica.io/bill/116-HR-3947/)