Pharmaceutical Agreement Filing Procedures Updated

The Federal Trade Commission is modernizing the process for filing agreements under the Medicare Prescription Drug, Modernization, and Improvements Act of 2003, or MMA, by requiring electronic filing instead of hard-copy submission. Starting June 17, 2019, MMA filings should be submitted to both the FTC at mma@ftc.gov and the Antitrust Division of the U.S. Department of Justice at mma@usdoj.gov. Companies will receive an emailed confirmation letter, along with a tracking number assigned by the agencies for use in any future correspondence about the filing.

The Commission is also providing filing procedures for biological/biosimilar settlements, which are covered by 2018 amendments to the MMA. Effective October 10, 2018, agreements between brand and biosimilar drug manufacturers regarding the manufacture, marketing, and sale of biosimilar versions of reference drug products must be filed with the FTC and the DOJ. Parties must also file certain agreements between biosimilar drug manufacturers that have submitted applications to the FDA for the same reference drug product. A cover sheet for biosimilar filings can be found at MMA Pharmaceutical Agreement Filing Cover Sheet (BLAs).

The recent amendments to the MMA also expanded the types of documents that must be submitted with any relevant agreement. For example, the MMA now requires parties to submit to the agencies any agreements that the parties entered into within 30 days before or after a relevant agreement. Updated guidance documents to assist with MMA filings and a cover sheet for New Drug Application/Abbreviated New Drug Application filings can be found at MMA Pharmaceutical Agreement Filing Instructions, MMA Pharmaceutical Agreement Filing FAQs, and MMA Pharmaceutical Agreement Filing Cover Sheet (NDAs/ANDAs).