Covington has decades of experience accomplishing the goals of the life sciences industry in the federal and state legislative arenas.
Our lawyers and professionals have, for example, been actively involved in every major federal legislative initiative that has affected pharmaceutical regulation. This representation has included assistance with respect to the Food and Drug Administration Modernization Act (FDAMA) of 1997, the Orphan Drug Act, the Drug Price Competition and Patent Term Restoration (Hatch-Waxman) Act, the FDA Export Reform and Enhancement Act of 1996, the Drug Export Amendments of 1986, the Prescription Drug User Fee Act (PDUFA) and each subsequent reauthorization of PDUFA, and the Medicare Modernization Act. We also advise pharmaceutical industry clients (including trade associations) with respect to state laws affecting the industry, including product liability reform legislation and marketing disclosure laws. Our legislative work for the drug industry has also included work on animal drug legislation, including the Animal Medicinal Drug Use Clarification Act, the Animal Drug Availability Act, and the Generic Animal Drug and Patent Term Restoration Act.
Covington has also been deeply involved in major federal legislative initiatives affecting conventional food and dietary supplements, and we advise members of the organic food industry on both federal and state legislative matters. This has included extensive work on the Nutrition Labeling and Education Act of 1990 (NLEA), the Dietary Supplement Health and Education Act of 1994, Food Quality Protection Act of 1996 (FQPA), and FDAMA, on behalf of the Grocery Manufacturers of America (GMA), the Food Products Association (FPA), and other food industry groups. We were also involved in the food-related provisions of the Bioterrorism Act of 2002 and the Minor Use and Minor Species Animal Health Act of 2004 (MUMS).
Our work on behalf of trade associations and individual companies, both at the federal level and at the state level, has included drafting and negotiating bills and amendments, testifying before committees, representing client witnesses before committees, meeting with staff and members, analyzing and summarizing legislative proposals, and preparing talking points and advocacy documents. Our decades of experience with the life sciences industry, coupled with substantive expertise of the lawyers in the various practice groups that work with the industry, and with the practical 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
- We have represented PhRMA for decades on legislative matters relating to the Federal Food, Drug, and Cosmetic Act (FDCA) and the Public Health Service Act (PHSA). Key areas of representation in recent years have included drug importation, Hatch Waxman reform, 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.
- Working with key leadership offices, congressional committees, FDA, and CMS, lawyers in our Food and Drug, Health Care, and Government Affairs practice groups assisted Kos Pharmaceuticals in persuading CMS to reverse its original position and deem Niaspan® a covered Part D drug.
- We represented Chiron, GlaxoSmithKline, Merck, and other major vaccine manufacturers in negotiating the December 2005 passage of the Public Readiness and Emergency Preparedness Act (PREP Act), which provides liability protection for manufacturers of countermeasures such as pandemic influenza vaccine.
- Following a crippling federal appellate court decision in January 2005, we represented the interests of hundreds of organic companies in securing a Congressional reversal of the decision in November of the same year. The firm negotiated a remand to the federal agency and a stay of the court’s decision for one year to enable Congress to act.
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