Covington & Burling LLP | Practices, Industries & Regions

Covington’s food and drug lawyers have been actively involved in every major legislative amendment to the statutes implemented by FDA since enactment of the FDCA in 1938. We were deeply involved in the Food and Drug Administration Modernization Act of 1997, the Medicare Modernization Act in 2003, the Food and Drug Administration Amendments Act of 2007, the Biologics Price Competition and Innovation Act of 2009, and the Food Safety Modernization Act of 2010, for example. Our work on these and other statutes has included representation of the major trade associations as well as individual companies, and it often begins with legal and regulatory assessments and policy work years before any draft bills are circulated. It typically includes assistance with analysis, advocacy, and risk mitigation as bills move through Congress, and it moves to advice on compliance (or litigation) after enactment. We work closely with the Washington offices of our largest industry clients. Our decades of experience representing regulated industry at FDA and our deep experience with industry, coupled with the legislative expertise of our Government Affairs practice group, enable us to provide an integrated approach on legislative matters that is unmatched in the profession.

Representative Matters

We were primary outside counsel to a large coalition of biological product innovators that played the pivotal industry role during the multi-year negotiation process that led to enactment of the new biosimilars law in March 2010.
We have represented PhRMA for decades on federal legislative matters including with respect to user fees, drug safety, Hatch-Waxman reform, pediatric exclusivity, clinical trial reporting, pediatric exclusivity, biosimilars, drug importation, and bioterrorism. We work with many individual PhRMA member companies (and other innovators) on these same bills.
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 worked with key leadership offices, congressional committees, FDA, and CMS to persuade CMS to reverse its original position and deem Kos Pharmaceutical’s product, Niaspan, a covered Part D drug.