Covington is the recognized leader with respect to FDA regulatory practice involving human pharmaceuticals and biological products. The practice group provides regulatory counsel to most of the world’s leading biopharmaceutical manufacturers, as well as PhRMA and other trade associations and informal industry groups. With five actively practicing alumni of the Chief Counsel’s and Commissioner’s office, and a deep bench of senior lawyers that has more than 100 years of combined experience in this area, we advise on all aspects of human pharmaceutical regulation — from strategic advocacy, to compliance, to enforcement, to litigation, and in all subject areas from preclinical development to end-of-lifecycle planning.
We work with companies on all aspects of clinical trials and good clinical practices. For example, we have advised clients on clinical trial recruitment activities, investigator financial disclosure requirements, responding to potential investigator misconduct, and structuring clinical trial and genetic testing informed consents.
We have decades of experience representing companies and individuals during the negotiation of good manufacturing practice (GMP) consent decrees with FDA, often successfully limiting the scope of these decrees and protecting individual defendants. We also have extensive experience advising clients on high profile drug safety issues and are frequently involved in high stakes product recall and labeling change (and REMS) issues. Our decades of work in this space give us a unique perspective on the evolution in FDA’s views on drug safety and product quality, enabling us to advise clients proactively on quality systems requirements and compliance strategies.
Covington attorneys were instrumental in drafting the initial PhRMA code and have been deeply involved with implementation of the federal sunshine law and the various state marketing and disclosure laws. We work with many pharmaceutical companies on their sales and marketing practices, performing compliance audits, defending enforcement actions, and advising on marketing strategies. We have also defended numerous companies in enforcement actions involving promotional issues and fraud and abuse issues.
- Covington is representing Genentech in its challenge of FDA’s decision to withdraw approval of Avastin for the indication of metastatic breast cancer.
- Recent consent decrees on which we were counsel include the 2010 consent decree relating to Genzyme’s Allston Landing manufacturing facility. We were also counsel for another major drug manufacturer in the negotiation of a 2011 consent decree regarding OTC manufacturing facilities.
- We have advised several major pharmaceutical companies on regulatory issues concerning high profile safety issues, including advice on public announcements, the FDA advisory committee process, coordination of scientific and regulatory presentations, and labeling revisions.
- We represented Chiron Corporation with respect to the manufacturing issues surrounding its flu vaccine for the 2005-2006 season.
- Chambers Global (2012)
- Life Sciences, Global-wide
- Chambers USA (2012)
- Life Sciences, Nationwide
- Life Sciences, CA
- Chambers UK (2012)
- Life Sciences, UK-wide
- Life Sciences, Regulatory, UK-wide
- Chambers Asia (2012)
- Life Sciences (International Firms), China
- PLC Cross-border Super League
- Ranked 1st in the Life Sciences Regulatory Super League (2004-2011)
- Ranked 1st in the Life Sciences Industry Super League (2005-2010)
- PLC - Life Sciences, Which Law Firm? (2012)
- Leading: Life Sciences, England, EU, and USA
- Leading; Government Enforcement and Investigations, USA
- Leading: Regulatory, Belgium, England, EU, and USA
- Highly Recommended: Life Sciences, Belgium
- LMG Life Sciences (2012)