Bill > HR3947

This bill, the Competition Prescription Act of 2019, aims to lower the cost of prescription drugs in the United States. Key provisions of the bill include: 1. Allowing eligible product developers to take legal action against license holders who decline to provide sufficient quantities of a covered product (i.e., a drug or biological product) on commercially reasonable, market-based terms. This provision is intended to address delays in the development of generic drugs and biosimilar products. 2. Establishing a program to expedite the development and provide priority review for generic "complex drug products," which are drugs with complex active ingredients, formulations, routes of delivery, or dosage forms. 3. Preempting state laws that prohibit pharmacies from substituting a biosimilar product for a reference biological product. 4. Requiring Medicare Part B to pay for biological biosimilar products using a uniform billing code, rather than separate codes for each biosimilar. 5. Creating a Chief Pharmaceutical Negotiator within the Office of the United States Trade Representative to advocate for U.S. pharmaceutical interests in trade negotiations and agreements. The overall goal of the bill is to increase competition and access to prescription drugs, particularly generic and biosimilar products, in order to lower drug costs for consumers.

Business and Industry, Justice, Military Affairs and Security

https://www.congress.gov/bill/116th-congress/house-bill/3947/all-info