Sidley has extensive experience in the Food, Drug and Medical Device Compliance and Enforcement arena and is top-ranked by Chambers USA, Chambers Global and PLC Life Sciences Handbooks for the depth of the practice.
Our lawyers advised pharmaceutical, biological, medical device and food clients on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Quality System Regulation (QSR) matters in more than 20 countries, assisted manufacturers to design and implement comprehensive compliance programs, handle sensitive internal investigations of compliance matters. We represented numerous clients in FDA, HHS, Office of Inspector General (OIG), Department of Defense and Department of Justice investigations and enforcement actions, and successfully defended clients before a variety of agencies and in court when necessary.
A number of our lawyers have worked at government agencies in various senior positions, including:
- Acting General Counsel of the United States Department of Health and Human Services (HHS),
- Acting Chief Counsel/Deputy Chief Counsel of FDA,
- a Health Policy Advisor to the Senate Committee of Health, Education, Labor and Pensions (HELP) and served in the Office of Chief Counsel, the Office of the Commissioner at FDA for 17 years,
- a legislative counsel and parliamentarian to the House Energy and Commerce Committee
- a staff Attorney/Special Assistant to the Chief Counsel of FDA,
- a staff lawyer in the FDA’s Office of Chief Counsel/Special Assistant United States Attorney,
- a few federal prosecutors—including one who was in charge of FDA’s special prosecution task force,
- an official at the Ministry of Health of P.R.C.,
- Head of Legal Service at the European Medicines Agency (EMA),
- a member of the European Commission’s Legal Service with responsibility for review of all food - and drug - related proposals, and
- an official in the European Commission’s Directorate General for Health and Consumers.
Our group also has U.S.-qualified physicians, a bioethicist and a Ph.D. geneticist and a former quality control microbiologist.
Achievements
- In the inaugural edition of Euromoney’s LMG Life Sciences 2012, Sidley is chosen as one of the nine Life Cycle firms, based on the breadth of their life sciences practice and by meeting a threshold number of life sciences stars across at least three practice area chapters. Sidley is top ranked in Government Investigation/Fraud & Abuse area. Scott Bass, Raymond Bonner, Kimberly Dunne, Paul Kalb, Richard Raskin and Greer Lautrup are featured as “Life Sciences Stars” for their outstanding Government Investigation/Fraud & Abuse work.
- Sidley Austin is the only law firm with top tier life sciences rankings across three continents in the PLC Life Sciences Handbook 2012. Sidley’s global Life Sciences industry practice has been continuously recognized by Practical Law Company (PLC) in its Cross-border Life Sciences Handbook since 2007. Most recently, Sidley was recognized in the PLC Life Sciences Cross-Border Handbook 2012. Sidley received a leading ranking, the guide’s top honor, in the areas of: Corporate & Commercial (China/Hong Kong); Government Enforcement and Investigations (U.S.); Product Liability (U.S.); Regulatory (U.S.); Regulatory (Medical Device, U.S.); Pricing and Reimbursement (U.S.); Regulatory (EU) and Highly Recommended ranking in the areas of: Corporate (U.S.), Competition/Antitrust (U.S.), Intellectual Property (U.S.), Patent Counseling (U.S.), and Competition/Antitrust (EU). For the third year in a row, Sidley is the only law firm to receive a leading ranking in the Corporate & Commercial (China/Hong Kong) category. In total, the firm received recommendations in 13 practice areas in three jurisdictions, and leading lawyer rankings for 20 lawyers, including Scott Bass, Raymond Bonner and Paul Kalb who have been ranked as leading lawyers in the area of Government Enforcement and Investigations (U.S.)
- Sidley is again top ranked in the Life Sciences Super League and Life Sciences Regulatory Super League by PLC in 2012.
- Sidley received first-tier national rankings in FDA Law and Biotechnology Law, as well as first-tier rankings in Washington D.C. in both practice areas in the U.S. News – Best Lawyers “Best Law Firms” rankings for 2013, and the most first-tier national rankings of any U.S. law firm overall for the third consecutive year, and each year since the survey’s inception.
- Sidley is ranked in first-tier in Life Sciences by Legal 500 USA 2011. Government enforcement is particularly addressed among other areas of focus of Sidley’s Life Sciences Practice.
- Sidley Austin LLP has been named as the number one law firm in the United States for Life Sciences in The International Who’s Who of Life Sciences Lawyers, published by Who’s Who Legal in February 2010. Eight partners from Sidley’s Chicago, Los Angeles, New York and Washington, D.C. offices are recognized as leaders in the field, a figure unmatched by any other firm in the guide.
- Since 2008, Sidley received Global Life Sciences Rankings from Chambers Global, and a National Life Sciences ranking from Chambers USA. Sidley also received national and state rankings in a specific life sciences compliance and enforcement discipline: Life Sciences: Regulatory and Compliance. Scott Bass and Raymond Bonner are recognized as the leaders in the field of laws.
- BTI Consulting Group, Inc., an independent research firm, named Sidley as the single “Pharmaceuticals Most Recommended Law Firm” and the single “Pharmaceuticals Leading Short Lister” in its 2008 Industry Power Rankings based on its interviews with industry insiders.