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. 

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 Chief Counsel of the U.S. FDA, 
  • Health Policy Advisor to the Senate Committee of Health, Education, Labor and Pensions (HELP), previously Staff Attorney in the Office of the Chief Counsel at FDA and in the Office of the Commissioner of Food and Drugs, 
  • Legislative counsel and parliamentarian to the House Energy and Commerce Committee, 
  • Staff Attorney/Special Assistant to the Chief Counsel of FDA, 
  • Counselor in the Office of the Commissioner at the FDA, previously the Deputy Director for Policy in the Center for Devices and Radiological Health, FDA,
  • FDA Staff Attorney/Special Assistant United States Attorney,
  • Assistant Commissioner at the FDA;
  • Federal prosecutors—including one who was in charge of FDA’s special prosecution task force,
  • 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 Ph.D. geneticist, a doctor of law and a former quality control microbiologist.

 Achievements

  • Sidley won four awards, including the biggest honor of the evening “Life Cycle Firm of the Year” at the annual Legal Media Group Life Sciences Awards held on September 14, 2016. 
  • In 2016, for the sixth consecutive year, Sidley received the most first-tier national rankings in the U.S. News – Best Lawyers® “Best Law Firms” including FDA Law and Biotechnology Law. Sidley also received first-tier rankings in FDA Law and Biotechnology Law in Washington, D.C., and a first-tier ranking in Biotechnology Law in San Francisco.
  • Sidley was named one of Law360’s Life Sciences Practice Groups of the Year for 2015.
  • In 2016, The Legal 500 US ranked Sidley in its top tier for Healthcare: Life Sciences for the fifth consecutive year.
  • Since 2008, Sidley has continuously been recognized by Chambers Global and Chambers USA in its Global Life Sciences and National Life Sciences rankings. Sidley also received national and state rankings in two specific life sciences regulatory disciplines: Life Sciences: Regulatory and Compliance and Healthcare: Pharmaceutical/Medical Products Regulatory.
  • 37 lawyers from Sidley’s Beijing, Brussels, Chicago, Los Angeles, New York, Shanghai, Sydney, Tokyo and Washington, D.C. offices are recognized in the 2016 edition of Who’s Who Legal: Life Sciences.
  • In the fourth edition of Euromoney’s LMG Life Sciences 2015, Sidley is again one of ten Life Cycle firms and received the highest rankings (Highly Recommended) in 11 practice areas, including FDA – Pharmaceutical, FDA – Medical Devices, General Patent Litigation and Government Investigation/Fraud & Abuse. 

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 Chief Counsel of the U.S. FDA, 
  • Health Policy Advisor to the Senate Committee of Health, Education, Labor and Pensions (HELP), previously Staff Attorney in the Office of the Chief Counsel at FDA and in the Office of the Commissioner of Food and Drugs, 
  • Legislative counsel and parliamentarian to the House Energy and Commerce Committee, 
  • Staff Attorney/Special Assistant to the Chief Counsel of FDA, 
  • Counselor in the Office of the Commissioner at the FDA, previously the Deputy Director for Policy in the Center for Devices and Radiological Health, FDA,
  • FDA Staff Attorney/Special Assistant United States Attorney,
  • Assistant Commissioner at the FDA;
  • Federal prosecutors—including one who was in charge of FDA’s special prosecution task force,
  • 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 Ph.D. geneticist, a doctor of law and a former quality control microbiologist.

 Achievements

  • Sidley won four awards, including the biggest honor of the evening “Life Cycle Firm of the Year” at the annual Legal Media Group Life Sciences Awards held on September 14, 2016. 
  • In 2016, for the sixth consecutive year, Sidley received the most first-tier national rankings in the U.S. News – Best Lawyers® “Best Law Firms” including FDA Law and Biotechnology Law. Sidley also received first-tier rankings in FDA Law and Biotechnology Law in Washington, D.C., and a first-tier ranking in Biotechnology Law in San Francisco.
  • Sidley was named one of Law360’s Life Sciences Practice Groups of the Year for 2015.
  • In 2016, The Legal 500 US ranked Sidley in its top tier for Healthcare: Life Sciences for the fifth consecutive year.
  • Since 2008, Sidley has continuously been recognized by Chambers Global and Chambers USA in its Global Life Sciences and National Life Sciences rankings. Sidley also received national and state rankings in two specific life sciences regulatory disciplines: Life Sciences: Regulatory and Compliance and Healthcare: Pharmaceutical/Medical Products Regulatory.
  • 37 lawyers from Sidley’s Beijing, Brussels, Chicago, Los Angeles, New York, Shanghai, Sydney, Tokyo and Washington, D.C. offices are recognized in the 2016 edition of Who’s Who Legal: Life Sciences.
  • In the fourth edition of Euromoney’s LMG Life Sciences 2015, Sidley is again one of ten Life Cycle firms and received the highest rankings (Highly Recommended) in 11 practice areas, including FDA – Pharmaceutical, FDA – Medical Devices, General Patent Litigation and Government Investigation/Fraud & Abuse. 
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