Covington has a leading food and drug practice recognized internationally for its breadth and depth of expertise.  Our lawyers and professionals have been actively involved in all of the major legislative initiatives that have affected pharmaceutical regulation, beginning with its representation of the National Canners Association in 1919.  The firm’s practice features two former Chief Counsels of the FDA and former key staff on health care congressional committees.

Public Policy and Government Affairs is a key component of the firm’s food and drug practice.  The firm’s substantive and political experts have assisted clients with their policy concerns on a broad range of legislation, including the 1997 enactment of the Food and Drug Administration Modernization Act, the Orphan Drug Act, the Drug Price Competition and Patent Term Restoration Act, the FDA Export Reform and Enhancement Act of 1996, the Drug Export Amendments of 1986, the Prescription Drug User Fee Act, and the Medicare Modernization Act, among others.  Our work on behalf of trade associations and individual companies has included drafting and negotiating bills and amendments, testifying before congressional committees, representing client witnesses before congressional committees, meeting with congressional staff and members, analyzing and summarizing legislative proposals, and preparing talking points and advocacy documents. Our vast substantive knowledge of FDA law and our wide experience in the industry, coupled with the legislative expertise of our Public Policy and Government Affairs practice group enable us to provide an integrated approach on legislative matters that is unmatched in the profession. 

Representative Matters

  • Kos Pharmaceuticals, Inc.- Working with key leadership offices, congressional committees, FDA and CMS, lawyers in our Food and Drug, Health Care, and Public Policy and Government Affairs practice areas assisted Kos in persuading CMS to reverse its original position  and deem Niaspan® a covered Part D drug.
  • PhRMA - We have long represented PhRMA on legislative matters relating to the FDCA and the PHSA on the Hill.  Key areas of representation in recent years have included drug importation, Hatch Waxman reform in 2003, pediatric exclusivity, drug safety, clinical trials legislation, drug user fee reauthorization, and bioterrorism.  We also advise a number of individual PhRMA member companies on these same issues. 
  • Chiron and GlaxoSmithKline, among others - We worked with an informal consortium of vaccine manufacturers in 2005 to secure passage of critical liability protection for manufacturers of pandemic flu vaccine.  We have worked with other informal groups of manufacturers on a variety of legislative issues relating to biologics.
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