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John focuses on advising tobacco manufacturers, wholesalers, distributors, retailers, and suppliers in all aspects of their businesses, including tobacco taxation matters, compliance with the Family Smoking Prevention and Tobacco Control Act and related FDA rules and guidance, administrative disputes involving federal and state governmental entities, and commercial agreements. He works with clients in all segments of the tobacco industry, including electronic nicotine delivery systems and other novel products and traditional tobacco products such as cigarettes, cigars, snus, and moist snuff. 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O'Brien is a counsel of our Product Liability \u0026 Mass Torts Practice Group. Read more.","primary_title_id":14,"translated_fields":{"en":{"bio":"\u003cp\u003eJohn O\u0026rsquo;Brien leverages nearly two decades of experience in legal practice and senior in-house counsel roles to advise clients on legal, regulatory, compliance and enforcement matters across FDA-regulated industries, including tobacco.\u0026nbsp;\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePrior to joining King \u0026amp; Spalding, John served as Vice President and Assistant General Counsel at Reynolds, where he counseled Reynolds\u0026rsquo; operating companies on various high-profile regulatory, marketing, and litigation matters. John focuses on advising tobacco manufacturers, wholesalers, distributors, retailers, and suppliers in all aspects of their businesses, including tobacco taxation matters, compliance with the Family Smoking Prevention and Tobacco Control Act and related FDA rules and guidance, administrative disputes involving federal and state governmental entities, and commercial agreements. He works with clients in all segments of the tobacco industry, including electronic nicotine delivery systems and other novel products and traditional tobacco products such as cigarettes, cigars, snus, and moist snuff. John also assists clients with FDA premarket and postmarket requirements, including substantial equivalence (SE), premarket tobacco applications (PMTA), modified risk tobacco product applications (MRTPA), and has helped companies obtain numerous FDA marketing orders for new tobacco products, including FDA\u0026rsquo;s first marketing granted order for an e-cigarette.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eJohn frequently presents on tobacco regulatory matters at conferences, including the Food and Drug Law Institute, Next Generation Nicotine Delivery USA, American Tobacco and Nicotine Forum, and CStore Connections conferences.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn addition to his extensive tobacco regulatory experience, John spent over a decade in private practice, counseling food, supplement, and other consumer packaged goods companies on FDA, USDA, and FTC regulatory matters, including enforcement actions, civil litigation, investigations, inspections, product recalls, claims substantiation, labeling, and compliance.\u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eAdmitted\u0026nbsp;only\u0026nbsp;in\u0026nbsp;IL\u0026nbsp;and\u0026nbsp;GA.\u0026nbsp;Supervised\u0026nbsp;by\u0026nbsp;D.C.\u0026nbsp;Bar\u0026nbsp;Members\u003c/em\u003e\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":12885}]},"capability_group_id":2},"created_at":"2025-09-11T20:12:29.000Z","updated_at":"2025-09-11T20:12:29.000Z","searchable_text":"O'Brien{{ FIELD }}John O’Brien leverages nearly two decades of experience in legal practice and senior in-house counsel roles to advise clients on legal, regulatory, compliance and enforcement matters across FDA-regulated industries, including tobacco.  \nPrior to joining King \u0026amp; Spalding, John served as Vice President and Assistant General Counsel at Reynolds, where he counseled Reynolds’ operating companies on various high-profile regulatory, marketing, and litigation matters. John focuses on advising tobacco manufacturers, wholesalers, distributors, retailers, and suppliers in all aspects of their businesses, including tobacco taxation matters, compliance with the Family Smoking Prevention and Tobacco Control Act and related FDA rules and guidance, administrative disputes involving federal and state governmental entities, and commercial agreements. He works with clients in all segments of the tobacco industry, including electronic nicotine delivery systems and other novel products and traditional tobacco products such as cigarettes, cigars, snus, and moist snuff. John also assists clients with FDA premarket and postmarket requirements, including substantial equivalence (SE), premarket tobacco applications (PMTA), modified risk tobacco product applications (MRTPA), and has helped companies obtain numerous FDA marketing orders for new tobacco products, including FDA’s first marketing granted order for an e-cigarette.  \nJohn frequently presents on tobacco regulatory matters at conferences, including the Food and Drug Law Institute, Next Generation Nicotine Delivery USA, American Tobacco and Nicotine Forum, and CStore Connections conferences. \nIn addition to his extensive tobacco regulatory experience, John spent over a decade in private practice, counseling food, supplement, and other consumer packaged goods companies on FDA, USDA, and FTC regulatory matters, including enforcement actions, civil litigation, investigations, inspections, product recalls, claims substantiation, labeling, and compliance.  \nAdmitted only in IL and GA. Supervised by D.C. Bar Members John F. O'Brien lawyer Counsel Northwestern University Northwestern Pritzker School of Law University of Illinois at Urbana-Champaign University of Illinois College of Law University of Illinois at Urbana-Champaign University of Illinois College of Law Georgia Illinois","searchable_name":"John F. O'Brien","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":444812,"version":1,"owner_type":"Person","owner_id":3180,"payload":{"bio":"\u003cp\u003eCaitlyn regularly counsels pharmaceutical, biotech, and medical device\u0026nbsp;companies on a variety of regulatory, compliance, and enforcement issues that impact their sales, marketing, and pricing activities. She has\u0026nbsp;specific expertise and experience providing strategic advice on laws that regulate drug pricing decisions, federal and state initiatives focused on driving transparency into financial relationships between manufacturers and health care providers, and myriad laws and industry standards that govern and restrict how companies interact with health care providers (e.g., gift bans, compliance program mandates, the PhRMA/AdvaMed Codes, sales representative licensing/registration requirements, federal and state government ethics laws, and lobbying laws).\u0026nbsp;She also has substantial experience counseling clients on the Inflation Reduction Act's Medicare Drug Price Negotiation Program, including from initial drug selection through implementation of maximum fair price.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCaitlyn also provides counsel to the Ad Hoc Sunshine and State Law Compliance Group (a coalition of pharmaceutical, biotechnology, and medical device manufacturers) on a variety of laws and regulations, including the federal Physician Payments Sunshine Act and\u0026nbsp;related state laws, as well as state drug price transparency, prescription drug affordability board (PDAB), and price gouging laws.\u003c/p\u003e","slug":"caitlyn-ozier","email":"cozier@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":81,"guid":"81.capabilities","index":0,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":1,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":2,"source":"capabilities"}],"is_active":true,"last_name":"Ozier","nick_name":"Caitlyn","clerkships":[],"first_name":"Caitlyn","title_rank":9999,"updated_by":202,"law_schools":[{"id":1732,"meta":{"degree":"J.D.","honors":"cum laude","is_law_school":"1","graduation_date":"2013-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"J.","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":14,"translated_fields":{"en":{"bio":"\u003cp\u003eCaitlyn regularly counsels pharmaceutical, biotech, and medical device\u0026nbsp;companies on a variety of regulatory, compliance, and enforcement issues that impact their sales, marketing, and pricing activities. She has\u0026nbsp;specific expertise and experience providing strategic advice on laws that regulate drug pricing decisions, federal and state initiatives focused on driving transparency into financial relationships between manufacturers and health care providers, and myriad laws and industry standards that govern and restrict how companies interact with health care providers (e.g., gift bans, compliance program mandates, the PhRMA/AdvaMed Codes, sales representative licensing/registration requirements, federal and state government ethics laws, and lobbying laws).\u0026nbsp;She also has substantial experience counseling clients on the Inflation Reduction Act's Medicare Drug Price Negotiation Program, including from initial drug selection through implementation of maximum fair price.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCaitlyn also provides counsel to the Ad Hoc Sunshine and State Law Compliance Group (a coalition of pharmaceutical, biotechnology, and medical device manufacturers) on a variety of laws and regulations, including the federal Physician Payments Sunshine Act and\u0026nbsp;related state laws, as well as state drug price transparency, prescription drug affordability board (PDAB), and price gouging laws.\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":1095}]},"capability_group_id":2},"created_at":"2026-01-06T18:11:14.000Z","updated_at":"2026-01-06T18:11:14.000Z","searchable_text":"Ozier{{ FIELD }}Caitlyn regularly counsels pharmaceutical, biotech, and medical device companies on a variety of regulatory, compliance, and enforcement issues that impact their sales, marketing, and pricing activities. She has specific expertise and experience providing strategic advice on laws that regulate drug pricing decisions, federal and state initiatives focused on driving transparency into financial relationships between manufacturers and health care providers, and myriad laws and industry standards that govern and restrict how companies interact with health care providers (e.g., gift bans, compliance program mandates, the PhRMA/AdvaMed Codes, sales representative licensing/registration requirements, federal and state government ethics laws, and lobbying laws). She also has substantial experience counseling clients on the Inflation Reduction Act's Medicare Drug Price Negotiation Program, including from initial drug selection through implementation of maximum fair price. \nCaitlyn also provides counsel to the Ad Hoc Sunshine and State Law Compliance Group (a coalition of pharmaceutical, biotechnology, and medical device manufacturers) on a variety of laws and regulations, including the federal Physician Payments Sunshine Act and related state laws, as well as state drug price transparency, prescription drug affordability board (PDAB), and price gouging laws. Counsel Saint Louis University Saint Louis University School of Law Saint Louis University Saint Louis University School of Law District of Columbia Georgia Missouri Texas American Health Lawyers Association Food and Drug Law Institute Publications Peer Review Committee","searchable_name":"Caitlyn J. Ozier","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":444043,"version":1,"owner_type":"Person","owner_id":7263,"payload":{"bio":"\u003cp\u003eTarra Olfat is an associate in King \u0026amp; Spalding's Washington D.C. office and a member of the firm's FDA \u0026amp; Life Sciences practice. Tarra assists medical device, pharmaceutical, food, beverage, and supplemental companies with regulatory, compliance, litigation, and enforcement issues.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eTarra earned her J.D. from the George Washington University Law School, where she served as a Kahan/FDA Fellow, helping to develop and promote GW's health law program through dedicated health law research and networking opportunities. Tarra also served as an editor on \u003cem\u003eThe George Washington Law Review\u003c/em\u003e, where she served as the Projects \u0026amp; Membership editor.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDuring her time at GW, Tarra gained valuable work experience through roles with the Centers for Medicare and Medicaid Services, Children's National Hospital, and the Office of Special Master. She holds a B.A. from the College of William \u0026amp; Mary.\u0026nbsp;\u003c/p\u003e","slug":"tarra-olfat","email":"tolfat@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":21,"guid":"21.capabilities","index":0,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":1,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":2,"source":"capabilities"}],"is_active":true,"last_name":"Olfat","nick_name":"Tarra","clerkships":[],"first_name":"Tarra","title_rank":9999,"updated_by":202,"law_schools":[{"id":753,"meta":{"degree":"J.D.","honors":"honors, Law Review","is_law_school":"1","graduation_date":"2025-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":" ","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":2,"translated_fields":{"en":{"bio":"\u003cp\u003eTarra Olfat is an associate in King \u0026amp; Spalding's Washington D.C. office and a member of the firm's FDA \u0026amp; Life Sciences practice. Tarra assists medical device, pharmaceutical, food, beverage, and supplemental companies with regulatory, compliance, litigation, and enforcement issues.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eTarra earned her J.D. from the George Washington University Law School, where she served as a Kahan/FDA Fellow, helping to develop and promote GW's health law program through dedicated health law research and networking opportunities. Tarra also served as an editor on \u003cem\u003eThe George Washington Law Review\u003c/em\u003e, where she served as the Projects \u0026amp; Membership editor.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDuring her time at GW, Tarra gained valuable work experience through roles with the Centers for Medicare and Medicaid Services, Children's National Hospital, and the Office of Special Master. She holds a B.A. from the College of William \u0026amp; Mary.\u0026nbsp;\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":13247}]},"capability_group_id":2},"created_at":"2025-12-08T20:28:03.000Z","updated_at":"2025-12-08T20:28:03.000Z","searchable_text":"Olfat{{ FIELD }}Tarra Olfat is an associate in King \u0026amp; Spalding's Washington D.C. office and a member of the firm's FDA \u0026amp; Life Sciences practice. Tarra assists medical device, pharmaceutical, food, beverage, and supplemental companies with regulatory, compliance, litigation, and enforcement issues. \nTarra earned her J.D. from the George Washington University Law School, where she served as a Kahan/FDA Fellow, helping to develop and promote GW's health law program through dedicated health law research and networking opportunities. Tarra also served as an editor on The George Washington Law Review, where she served as the Projects \u0026amp; Membership editor. \nDuring her time at GW, Tarra gained valuable work experience through roles with the Centers for Medicare and Medicaid Services, Children's National Hospital, and the Office of Special Master. She holds a B.A. from the College of William \u0026amp; Mary.  Associate College of William and Mary William \u0026amp; Mary Law School George Washington University George Washington University Law School","searchable_name":"Tarra Olfat","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":202,"capability_group_featured":null,"home_page_featured":null},{"id":427691,"version":1,"owner_type":"Person","owner_id":1600,"payload":{"bio":"\u003cp\u003eBill O'Connell is a Senior Quality Systems Expert with the firm\u0026rsquo;s FDA and Life Sciences practice in Washington, D.C.\u003c/p\u003e\n\u003cp\u003e[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eBill has more than 33 years of experience in Food and Drug matters, including nineteen years with the FDA. In addition, he spent fourteen years as a consultant to the pharmaceutical, biologic and medical device industries for a large internationally known consulting firm. Bill is nationally recognized for his knowledge of the application and interpretation of the CGMPs/QSR regulations for drugs, biologics and medical devices, and he is recognized as a national and international leader in the areas of equipment qualification, process validation, design controls and product and process risk assessment practices.\u003c/p\u003e\n\u003cp\u003eWhile at the FDA, Bill served as the Associate Director of the Division of Enforcement II, Office of Compliance of the Center for Devices and Radiological Health (\u0026ldquo;CDRH\u0026rdquo;). He was Section Chief of the Office of Compliance and Surveillance of the Manufacturing Quality Assurance Branch from 1991 to 1993. From 1989 to 1991, Bill was with the Generic Drug Compliance Branch of the Center for Drug Evaluation and Research, Office of Compliance. While in this position, he was assigned to the U.S. Attorney\u0026rsquo;s Office in Baltimore, Maryland as a GMP and Drug Manufacturing Process Expert and led several Grand Jury investigations into the Generic Drug Industry. From 1987 to 1989, Bill served as a National Expert for Medical Devices and Sterilization Processes in the Office of Regulatory Affairs where he was a Recognized Expert in sterile processes and aseptic processing of drug, biological, medical device and IVD products.\u003c/p\u003e\n\u003cp\u003eBill is a member of the Association for the Advancement of Medical Instrumentation, the American Society for Quality, and the International Standards Organization (ISO TC 198, Sterilization of Healthcare Products; ISO TC 209, Design and Operation of Clean Rooms; and ISO TC 210, Medical Devices).\u003c/p\u003e","slug":"william-o-connell","email":"woconnell@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":6,"guid":"6.aofs","index":0,"source":"aofs"},{"id":103,"guid":"103.capabilities","index":1,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":2,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":3,"source":"capabilities"}],"is_active":true,"last_name":"O'Connell","nick_name":"William","clerkships":[],"first_name":"William","title_rank":9999,"updated_by":101,"law_schools":[],"middle_name":"P.","name_suffix":"","recognitions":null,"linked_in_url":null,"seodescription":null,"primary_title_id":11,"translated_fields":{"en":{"bio":"\u003cp\u003eBill O'Connell is a Senior Quality Systems Expert with the firm\u0026rsquo;s FDA and Life Sciences practice in Washington, D.C.\u003c/p\u003e\n\u003cp\u003e[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eBill has more than 33 years of experience in Food and Drug matters, including nineteen years with the FDA. In addition, he spent fourteen years as a consultant to the pharmaceutical, biologic and medical device industries for a large internationally known consulting firm. Bill is nationally recognized for his knowledge of the application and interpretation of the CGMPs/QSR regulations for drugs, biologics and medical devices, and he is recognized as a national and international leader in the areas of equipment qualification, process validation, design controls and product and process risk assessment practices.\u003c/p\u003e\n\u003cp\u003eWhile at the FDA, Bill served as the Associate Director of the Division of Enforcement II, Office of Compliance of the Center for Devices and Radiological Health (\u0026ldquo;CDRH\u0026rdquo;). He was Section Chief of the Office of Compliance and Surveillance of the Manufacturing Quality Assurance Branch from 1991 to 1993. From 1989 to 1991, Bill was with the Generic Drug Compliance Branch of the Center for Drug Evaluation and Research, Office of Compliance. While in this position, he was assigned to the U.S. Attorney\u0026rsquo;s Office in Baltimore, Maryland as a GMP and Drug Manufacturing Process Expert and led several Grand Jury investigations into the Generic Drug Industry. From 1987 to 1989, Bill served as a National Expert for Medical Devices and Sterilization Processes in the Office of Regulatory Affairs where he was a Recognized Expert in sterile processes and aseptic processing of drug, biological, medical device and IVD products.\u003c/p\u003e\n\u003cp\u003eBill is a member of the Association for the Advancement of Medical Instrumentation, the American Society for Quality, and the International Standards Organization (ISO TC 198, Sterilization of Healthcare Products; ISO TC 209, Design and Operation of Clean Rooms; and ISO TC 210, Medical Devices).\u003c/p\u003e"},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{},"capability_group_id":2},"created_at":"2025-05-26T05:03:48.000Z","updated_at":"2025-05-26T05:03:48.000Z","searchable_text":"O'Connell{{ FIELD }}Bill O'Connell is a Senior Quality Systems Expert with the firm’s FDA and Life Sciences practice in Washington, D.C.\n\nBill has more than 33 years of experience in Food and Drug matters, including nineteen years with the FDA. In addition, he spent fourteen years as a consultant to the pharmaceutical, biologic and medical device industries for a large internationally known consulting firm. Bill is nationally recognized for his knowledge of the application and interpretation of the CGMPs/QSR regulations for drugs, biologics and medical devices, and he is recognized as a national and international leader in the areas of equipment qualification, process validation, design controls and product and process risk assessment practices.\nWhile at the FDA, Bill served as the Associate Director of the Division of Enforcement II, Office of Compliance of the Center for Devices and Radiological Health (“CDRH”). He was Section Chief of the Office of Compliance and Surveillance of the Manufacturing Quality Assurance Branch from 1991 to 1993. From 1989 to 1991, Bill was with the Generic Drug Compliance Branch of the Center for Drug Evaluation and Research, Office of Compliance. While in this position, he was assigned to the U.S. Attorney’s Office in Baltimore, Maryland as a GMP and Drug Manufacturing Process Expert and led several Grand Jury investigations into the Generic Drug Industry. From 1987 to 1989, Bill served as a National Expert for Medical Devices and Sterilization Processes in the Office of Regulatory Affairs where he was a Recognized Expert in sterile processes and aseptic processing of drug, biological, medical device and IVD products.\nBill is a member of the Association for the Advancement of Medical Instrumentation, the American Society for Quality, and the International Standards Organization (ISO TC 198, Sterilization of Healthcare Products; ISO TC 209, Design and Operation of Clean Rooms; and ISO TC 210, Medical Devices). Consultant","searchable_name":"William P. O'Connell","is_active":true,"featured":null,"publish_date":null,"expiration_date":null,"blog_featured":null,"published_by":101,"capability_group_featured":null,"home_page_featured":null}]}}