New Laws Expand Requirements for Pharmaceutical Companies to File Agreements With FTC and DOJ

New Laws Expand Requirements for Pharmaceutical Companies to File Agreements With FTC and DOJ

October 29, 2018

President Trump on October 24 signed the SUPPORT for Patients and Communities Act (H.R. 6), which together with the Patient Right to Know Drug Prices Act (S. 2554), signed October 10, expands the scope of pharmaceutical product-related agreements subject to filing requirements under subtitle B of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). Of particular note, parties to certain agreements regarding biosimilar applications now must file the agreements with the Department of Justice (DOJ) and the Federal Trade Commission (FTC). H.R. 6 also broadens the scope of required filings for agreements related to generic drugs. Clients should consider and plan for these new filing requirements as they negotiate and execute covered agreements.