Related Practices
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Covington lawyers have been actively involved in all of the major legislative initiatives that have affected pharmaceutical regulation, including the 1997 enactment of the Food and Drug Administration Modernization Act, as well as 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 these and other statutes has included representation of the major trade associations as well as individual companies as bills moved through Congress and advice on compliance after they became law. Our vast substantive knowledge of FDA law and our wide experience in the 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
- Kos Pharmaceuticals, Inc.- Working with key leadership offices, congressional committees, FDA and CMS, lawyers in our Food and Drug, Health Care, 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.
Accolades
- PLC Cross-border Super League (2005-2008)
- Ranked 1st in the Life Sciences Industry Super League
- Ranked 1st in the Life Sciences Regulatory Super League
- PLC - Life Sciences, Which Law Firm? (2006-2007)
- Leading: Regulatory firm, EU and USA
- PLC awarded Covington the Best International Practice Award 2006 in the life sciences area.
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