Following up on our prior reports, last week President Trump signed into law the “Patient Right to Know Drug Prices Act” (S.2554). Among other changes, the bill amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require that Reference Product Sponsors and biosimilar applicants file patent settlement agreements with the Federal Trade Commission (“FTC”) and the U.S. Department of Justice (“DOJ”) for review. The law imposes the same FTC and DOJ disclosure requirements currently in place for ANDA litigation settlements.
For our readers’ reference, a redline indicating the changes made to the prior law may be accessed here. Please note that this reflects additional changes that were made to these statutes under H.R. 6, the “SUPPORT for Patients and Communities Act,” which was signed by President Trump on October 24, 2018.