H.R. 3947

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.