Bill > HR1344

This bill, called the Competitive DRUGS Act of 2019 or the Competitive Deals Resulting in Unleashed Generics and Savings Act of 2019, aims to prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market. The key provisions of the bill include: 1. Allowing the Federal Trade Commission (FTC) to initiate proceedings against agreements between brand name and generic drug companies that provide anything of value to the generic company in exchange for the generic company limiting or forgoing the research, development, manufacturing, marketing, or sales of the generic drug product. There are some exceptions if the parties can demonstrate the value is solely for other goods/services or the pro-competitive benefits outweigh the anti-competitive effects. 2. Imposing a 50% tax on payments received by generic drug companies under such "pay-for-delay" agreements and denying deductions for those payments. 3. Requiring notice and certification of all agreements between brand name and generic drug companies related to patent infringement claims. 4. Expanding the FTC's litigation authority to enforce the provisions of the bill. 5. Establishing a 6-year statute of limitations for the FTC to commence enforcement proceedings. The goal is to discourage these types of "pay-for-delay" agreements that can delay the entry of lower-cost generic drugs and negatively impact consumer access and savings.

Government Affairs, Health and Social Services

https://www.congress.gov/bill/116th-congress/house-bill/1344/all-info