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- 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.
CREATES Act Becomes Law
January 13, 2020, Covington Alert
On December 20, 2019, the President signed the Further Consolidated Appropriations Act, 2020. Effective on that day, Section 610 of Division N of this Act contains provisions previously introduced in various bills as “the Creating and Restoring Equal Access to Equivalent Samples Act” or “CREATES Act.”
November 1, 2017
WASHINGTON—Covington represented CenturyLink in its acquisition of Level 3 Communications in a cash and stock transaction valued at approximately $34 billion. The acquisition closed today. The firm assisted Century Link in obtaining regulatory approvals by the Federal Communications Commission and state public utilities regulators, and in national security ...
Washington-area appointments and promotions for Oct. 20
October 20, 2014, The Washington Post
"Covington & Burling of the District appointed Ashley Bass, Robin Blaney, Krista Carver, Jeffrey Davidson, Nicole Duclos, Shankar Duraiswamy, Scott Freling, David Garr, Jason Goldberg, Andrew Lazerow, Michael Lechliter, Anne Lee, Scott Schrader, Nathan Shafroth and Ranganath Sudarshan partners."