Food, Drug and Medical Device Compliance and Enforcement
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.
For six Years in a row, Sidley has been ranked as one of the Leading Firms in Government Enforcement and Investigations category in the U.S.
PLC Life Sciences Handbook, 2007-2012
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 the FDA, USDA, FTC and EMA in various senior positions. Our group includes a former Acting FDA Chief Counsel, a former Special Assistant to the FDA Chief Counsel, former federal prosecutors—including one who was in charge of FDA’s special prosecution task force—and a former member of the European Commission’s Legal Service with responsibility for review of all food and drug related proposals. Our group also has a U.S.-qualified physician, an EU physician, a bioethicist and a Ph.D. geneticist.
Achievements
- 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 Chicago and Washington D.C. in both practice areas in the U.S.News – Best Lawyers “Best Law Firms” rankings for 2011/12, and the most first-tier national rankings of any U.S. law firm overall for the second straight year.
- 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.
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