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Rob is an expert on all aspects of the Department of Health and Human Services (HHS) Office of Inspector General (OIG) administrative remedies and initiatives, including mandatory and permissive exclusion authorities, the Civil Monetary Penalties Law, the Emergency Medical Treatment and Labor Act (EMTALA), corporate integrity agreements, Select Agent investigations, drug price reporting cases, and HHS OIG\u0026rsquo;s health care, grant, and contractor self-disclosure protocols. Rob has been a frequent presenter for many years at major national healthcare and life sciences conferences, conveying the government\u0026rsquo;s enforcement and compliance priorities.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eWith over 25 years of experience, including as the former Chief Counsel to HHS OIG, Rob advises healthcare and life sciences companies on complex regulatory and compliance issues. As the highest-ranking attorney for OIG, Rob served as a nationwide expert on the federal government\u0026rsquo;s development and implementation of health care compliance strategies for health care entities and compliance oversight by health care boards of directors. Rob oversaw all OIG legal services related to audits, investigations, fraud enforcement, and industry guidance. From early in his career as a line attorney with primary responsibility for OIG\u0026rsquo;s pneumonia upcoding national project, Rob has been significantly involved in many of the federal government\u0026rsquo;s major healthcare fraud and compliance initiatives over the past 25 years. As Chief Counsel, Rob served as the lead Deputy Inspector General for OIG\u0026rsquo;s updated compliance program guidance documents, setting forth best practices for entities that do business with the Federal health care programs, including Medicare and Medicaid.\u003c/p\u003e\n\u003cp\u003eBefore his role as Chief Counsel, he served for more than a decade as an Assistant Inspector General (AIG) for Legal Affairs. In that position, he was the signatory for OIG advisory opinions on the application of OIG's fraud and abuse authorities, including under the AKS, to the requesting party's existing or proposed business arrangements. He was also responsible for leading OIG\u0026rsquo;s legal work related to waivers of certain fraud and abuse laws for purposes of testing new health care payment and service delivery models developed by CMS. He has led OIG\u0026rsquo;s negotiation of Corporate Integrity Agreements (CIAs), with a wide range of providers from across the health care industry. From 2012 to 2016, he served as the OIG signatory on behalf of HHS for all False Claims Act (including qui tam) settlements and CIAs nationwide.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePrior to becoming AIG in 2012, Rob was the Chief of the Administrative and Civil Remedies Branch, the largest of three branches in the Office of Counsel.\u003c/p\u003e\n\u003cp\u003eIn 2007, Rob served as a Special Trial Attorney in DOJ\u0026rsquo;s Fraud Section, Criminal Division, where he prosecuted matters in connection with phase one of the Medicare Fraud Strike Force in the Southern District of Florida. In that role, Rob was co-counsel for the jury trial leading to conviction on all five criminal counts, including soliciting and receiving kickbacks, of a durable medical equipment company owner who conspired with two Miami pharmacies in a scheme to bill Medicare for expensive inhalation medications. Prior to working at OIG, he worked in the general counsel\u0026rsquo;s office at a managed care organization.\u003c/p\u003e","slug":"robert-deconti","email":"rdeconti@kslaw.com","phone":null,"matters":null,"taggings":{"tags":[],"meta_tags":[]},"expertise":[{"id":24,"guid":"24.capabilities","index":0,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":1,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":2,"source":"capabilities"},{"id":23,"guid":"23.capabilities","index":3,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":4,"source":"capabilities"},{"id":826,"guid":"826.smart_tags","index":5,"source":"smartTags"}],"is_active":true,"last_name":"DeConti","nick_name":"Rob","clerkships":[],"first_name":"Robert","title_rank":9999,"updated_by":202,"law_schools":[{"id":3042,"meta":{"degree":"J.D.","honors":"","is_law_school":"1","graduation_date":"1999-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"K.","name_suffix":"","recognitions":[{"title":"HHS Secretary’s Award for Distinguished Service","detail":""},{"title":"HHS Secretary’s Award for Meritorious Service","detail":""},{"title":"Inspector General’s Bronze Medal for Outstanding Employee of the Year (multiple awards)","detail":""},{"title":"Inspector General’s Award for Fighting Fraud, Waste, and Abuse","detail":""},{"title":"President’s Council on Integrity and Efficiency Award for Excellence","detail":""},{"title":"Office of Inspector General Cooperative Achievement Award (multiple awards)","detail":""},{"title":"Inspector General’s Exceptional Achievement Award (multiple awards)","detail":""}],"linked_in_url":"https://www.linkedin.com/in/robertdeconti","seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eRob DeConti is a partner in King \u0026amp; Spalding\u0026rsquo;s healthcare practice, specializing in government healthcare fraud investigations, compliance, diligence, the False Claims Act, the Anti-Kickback Statute (AKS), and regulatory compliance and enforcement issues in relation to healthcare transactions. Rob is an expert on all aspects of the Department of Health and Human Services (HHS) Office of Inspector General (OIG) administrative remedies and initiatives, including mandatory and permissive exclusion authorities, the Civil Monetary Penalties Law, the Emergency Medical Treatment and Labor Act (EMTALA), corporate integrity agreements, Select Agent investigations, drug price reporting cases, and HHS OIG\u0026rsquo;s health care, grant, and contractor self-disclosure protocols. Rob has been a frequent presenter for many years at major national healthcare and life sciences conferences, conveying the government\u0026rsquo;s enforcement and compliance priorities.\u0026nbsp;[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eWith over 25 years of experience, including as the former Chief Counsel to HHS OIG, Rob advises healthcare and life sciences companies on complex regulatory and compliance issues. As the highest-ranking attorney for OIG, Rob served as a nationwide expert on the federal government\u0026rsquo;s development and implementation of health care compliance strategies for health care entities and compliance oversight by health care boards of directors. Rob oversaw all OIG legal services related to audits, investigations, fraud enforcement, and industry guidance. From early in his career as a line attorney with primary responsibility for OIG\u0026rsquo;s pneumonia upcoding national project, Rob has been significantly involved in many of the federal government\u0026rsquo;s major healthcare fraud and compliance initiatives over the past 25 years. As Chief Counsel, Rob served as the lead Deputy Inspector General for OIG\u0026rsquo;s updated compliance program guidance documents, setting forth best practices for entities that do business with the Federal health care programs, including Medicare and Medicaid.\u003c/p\u003e\n\u003cp\u003eBefore his role as Chief Counsel, he served for more than a decade as an Assistant Inspector General (AIG) for Legal Affairs. In that position, he was the signatory for OIG advisory opinions on the application of OIG's fraud and abuse authorities, including under the AKS, to the requesting party's existing or proposed business arrangements. He was also responsible for leading OIG\u0026rsquo;s legal work related to waivers of certain fraud and abuse laws for purposes of testing new health care payment and service delivery models developed by CMS. He has led OIG\u0026rsquo;s negotiation of Corporate Integrity Agreements (CIAs), with a wide range of providers from across the health care industry. From 2012 to 2016, he served as the OIG signatory on behalf of HHS for all False Claims Act (including qui tam) settlements and CIAs nationwide.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePrior to becoming AIG in 2012, Rob was the Chief of the Administrative and Civil Remedies Branch, the largest of three branches in the Office of Counsel.\u003c/p\u003e\n\u003cp\u003eIn 2007, Rob served as a Special Trial Attorney in DOJ\u0026rsquo;s Fraud Section, Criminal Division, where he prosecuted matters in connection with phase one of the Medicare Fraud Strike Force in the Southern District of Florida. In that role, Rob was co-counsel for the jury trial leading to conviction on all five criminal counts, including soliciting and receiving kickbacks, of a durable medical equipment company owner who conspired with two Miami pharmacies in a scheme to bill Medicare for expensive inhalation medications. Prior to working at OIG, he worked in the general counsel\u0026rsquo;s office at a managed care organization.\u003c/p\u003e","recognitions":[{"title":"HHS Secretary’s Award for Distinguished Service","detail":""},{"title":"HHS Secretary’s Award for Meritorious Service","detail":""},{"title":"Inspector General’s Bronze Medal for Outstanding Employee of the Year (multiple awards)","detail":""},{"title":"Inspector General’s Award for Fighting Fraud, Waste, and Abuse","detail":""},{"title":"President’s Council on Integrity and Efficiency Award for Excellence","detail":""},{"title":"Office of Inspector General Cooperative Achievement Award (multiple awards)","detail":""},{"title":"Inspector General’s Exceptional Achievement Award (multiple awards)","detail":""}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":12841}]},"capability_group_id":2},"created_at":"2025-12-05T05:02:32.000Z","updated_at":"2025-12-05T05:02:32.000Z","searchable_text":"DeConti{{ FIELD }}{:title=\u0026gt;\"HHS Secretary’s Award for Distinguished Service\", :detail=\u0026gt;\"\"}{{ FIELD }}{:title=\u0026gt;\"HHS Secretary’s Award for Meritorious Service\", :detail=\u0026gt;\"\"}{{ FIELD }}{:title=\u0026gt;\"Inspector General’s Bronze Medal for Outstanding Employee of the Year (multiple awards)\", :detail=\u0026gt;\"\"}{{ FIELD }}{:title=\u0026gt;\"Inspector General’s Award for Fighting Fraud, Waste, and Abuse\", :detail=\u0026gt;\"\"}{{ FIELD }}{:title=\u0026gt;\"President’s Council on Integrity and Efficiency Award for Excellence\", :detail=\u0026gt;\"\"}{{ FIELD }}{:title=\u0026gt;\"Office of Inspector General Cooperative Achievement Award (multiple awards)\", :detail=\u0026gt;\"\"}{{ FIELD }}{:title=\u0026gt;\"Inspector General’s Exceptional Achievement Award (multiple awards)\", :detail=\u0026gt;\"\"}{{ FIELD }}Rob DeConti is a partner in King \u0026amp; Spalding’s healthcare practice, specializing in government healthcare fraud investigations, compliance, diligence, the False Claims Act, the Anti-Kickback Statute (AKS), and regulatory compliance and enforcement issues in relation to healthcare transactions. Rob is an expert on all aspects of the Department of Health and Human Services (HHS) Office of Inspector General (OIG) administrative remedies and initiatives, including mandatory and permissive exclusion authorities, the Civil Monetary Penalties Law, the Emergency Medical Treatment and Labor Act (EMTALA), corporate integrity agreements, Select Agent investigations, drug price reporting cases, and HHS OIG’s health care, grant, and contractor self-disclosure protocols. Rob has been a frequent presenter for many years at major national healthcare and life sciences conferences, conveying the government’s enforcement and compliance priorities. \nWith over 25 years of experience, including as the former Chief Counsel to HHS OIG, Rob advises healthcare and life sciences companies on complex regulatory and compliance issues. As the highest-ranking attorney for OIG, Rob served as a nationwide expert on the federal government’s development and implementation of health care compliance strategies for health care entities and compliance oversight by health care boards of directors. Rob oversaw all OIG legal services related to audits, investigations, fraud enforcement, and industry guidance. From early in his career as a line attorney with primary responsibility for OIG’s pneumonia upcoding national project, Rob has been significantly involved in many of the federal government’s major healthcare fraud and compliance initiatives over the past 25 years. As Chief Counsel, Rob served as the lead Deputy Inspector General for OIG’s updated compliance program guidance documents, setting forth best practices for entities that do business with the Federal health care programs, including Medicare and Medicaid.\nBefore his role as Chief Counsel, he served for more than a decade as an Assistant Inspector General (AIG) for Legal Affairs. In that position, he was the signatory for OIG advisory opinions on the application of OIG's fraud and abuse authorities, including under the AKS, to the requesting party's existing or proposed business arrangements. He was also responsible for leading OIG’s legal work related to waivers of certain fraud and abuse laws for purposes of testing new health care payment and service delivery models developed by CMS. He has led OIG’s negotiation of Corporate Integrity Agreements (CIAs), with a wide range of providers from across the health care industry. From 2012 to 2016, he served as the OIG signatory on behalf of HHS for all False Claims Act (including qui tam) settlements and CIAs nationwide. \nPrior to becoming AIG in 2012, Rob was the Chief of the Administrative and Civil Remedies Branch, the largest of three branches in the Office of Counsel.\nIn 2007, Rob served as a Special Trial Attorney in DOJ’s Fraud Section, Criminal Division, where he prosecuted matters in connection with phase one of the Medicare Fraud Strike Force in the Southern District of Florida. In that role, Rob was co-counsel for the jury trial leading to conviction on all five criminal counts, including soliciting and receiving kickbacks, of a durable medical equipment company owner who conspired with two Miami pharmacies in a scheme to bill Medicare for expensive inhalation medications. Prior to working at OIG, he worked in the general counsel’s office at a managed care organization. Partner HHS Secretary’s Award for Distinguished Service  HHS Secretary’s Award for Meritorious Service  Inspector General’s Bronze Medal for Outstanding Employee of the Year (multiple awards)  Inspector General’s Award for Fighting Fraud, Waste, and Abuse  President’s Council on Integrity and Efficiency Award for Excellence  Office of Inspector General Cooperative Achievement Award (multiple awards)  Inspector General’s Exceptional Achievement Award (multiple awards)  University of Virginia  American University Washington College of Law American University Washington College of Law District of Columbia Virginia Virginia State Bar American Health Law Association Government Attorney-at-Large, American Bar Association Health Law Section Council, 2022-2025 Government Liaison to the Health Care Compliance Association, Board of Directors, 2008-2012","searchable_name":"Robert K. DeConti (Rob)","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":435271,"version":1,"owner_type":"Person","owner_id":1973,"payload":{"bio":"\u003cp\u003eDan Donovan specializes in congressional, state attorneys general and parallel government investigations. A former Chief Investigative Counsel in the Senate, Dan co-chairs\u0026nbsp;our Government Advocacy and Congressional Investigations practices perennially recognized by \u003cem\u003eChambers USA\u003c/em\u003e: \u0026ldquo;King \u0026amp; Spalding is best known for its impressive congressional investigations practice, with several dedicated members working exclusively in this area.\u0026rdquo; Dan is ranked Band 1 for Congressional Investigations by \u003cem\u003eChambers USA \u003c/em\u003eand Tier 1 \u003cem\u003eLegal 500 US\u003c/em\u003e.\u0026nbsp; He\u0026nbsp;has two decades of crisis management experience with government investigations, involving significant legal, public relations and political risks.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eDan represents leading companies, individuals, trade associations, and nonprofit entities and provides effective crisis management counsel. He works at the forefront of controversial and politicized national and state policy issues that frequently lead to investigations and litigation, including congressional, multi-state and federal agency enforcement actions. Particularly experienced in anticipating and responding to congressional committee requests and subpoenas, Dan prepares clients for high-profile hearings and guides them through the unique challenges presented by congressional and parallel government investigations.\u003c/p\u003e\n\u003cp\u003eBefore joining the firm, Dan served as Senior Investigative Counsel to Senator Charles Grassley, then Chairman of the Committee on Finance. While serving in the U.S. Senate, Dan managed congressional investigations and oversight hearings. In this role, Dan directed investigations focused on statutory and regulatory compliance, including drug and device safety, drug pricing, and waste, fraud and abuse in Medicare, Medicaid and other government programs. He also handled policy and legislative matters, including the False Claims Act, the Food, Drug, and Cosmetic Act, Medicare and Medicaid programs, and related statutes. Dan also served as Chief Investigative Counsel to the Senate Committee on Small Business, where he managed consumer fraud and small business protection investigations and hearings. He began his congressional career as a Staff Assistant on the Senate Committee on Governmental Affairs, chaired by Senator Fred Thompson, working on the special investigation into the 1996 federal election campaigns.\u003c/p\u003e\n\u003cp\u003eDan also provides strategic policy and legislative counsel, and is a frequent speaker on congressional oversight and investigations.\u003c/p\u003e","slug":"daniel-donovan","email":"ddonovan@kslaw.com","phone":null,"matters":["\u003cp\u003eExperience representing numerous clients under investigation by Republican-controlled Senate and House Committees, including Senate Banking, Commerce, Finance, HELP, Homeland Security, Judiciary, Permanent Subcommittee on Investigations, Special Committee on Aging, and House Education and the Workforce, Energy \u0026amp; Commerce, Financial Services, Judiciary, Oversight and Reform, Select Subcommittee on the Coronavirus Crisis, Select Committee on CCP, and Ways \u0026amp; Means, among others.\u003c/p\u003e","\u003cp\u003eProviding advice and counsel with respect to congressional oversight activity to leading companies in private sector industries, including accounting, auto, banking, consulting, defense, energy, fashion, food, healthcare provider, higher education, insurance, medical device, pharmaceutical, private equity, and tech, among others.\u003c/p\u003e","\u003cp\u003eRepresenting\u0026nbsp;\u003cstrong\u003ea variety of clients\u003c/strong\u003e\u0026nbsp;in connection with investigations relating to allegations of government fraud, food and product safety and recalls, cybersecurity breaches, product pricing, clinical research, off-label promotion, direct-to-consumer advertising, payments to physicians, and financial conflicts of interest.\u003c/p\u003e","\u003cp\u003eRepresenting\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003emultiple pharmaceutical companies\u003c/strong\u003e\u0026nbsp;in connection with congressional and state attorneys general drug pricing investigations.\u003c/p\u003e","\u003cp\u003eRepresenting\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea variety of clients\u003c/strong\u003e\u0026nbsp;on healthcare policy and legislative issues.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea major university\u003c/strong\u003e\u0026nbsp;and\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical company\u003c/strong\u003e\u0026nbsp;in connection with the Select Panel on Infant Lives (authorized under the House Energy and Commerce Committee) investigation relating to fetal tissue research.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea global financial institution\u003c/strong\u003e\u0026nbsp;in connection with an investigation by the Senate Permanent Subcommittee on Investigations, regarding international tax matters.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea Big Four accounting firm\u003c/strong\u003e\u0026nbsp;in a Senate Finance Committee investigation of a University\u0026rsquo;s handling of federal funds.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003emultiple pharmaceutical companies\u003c/strong\u003e\u0026nbsp;in House and Senate investigations related to Affordable Care Act enactment and implementation.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003emedical device companies\u003c/strong\u003e\u0026nbsp;in connection with House and Senate committee investigations into 510(k) regulatory issues, direct-to-consumer advertising, and payments to physicians.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea leading clean energy technology company\u003c/strong\u003e\u0026nbsp;in connection with a Senate investigation into Department of Energy grant program.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea major oil company\u003c/strong\u003e\u0026nbsp;in connection with congressional investigations.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea health insurer\u003c/strong\u003e\u0026nbsp;in House and Senate investigations related to Affordable Care Act implementation.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea coalition of food product companies\u003c/strong\u003e\u0026nbsp;in connection with congressional inquiries relating to food safety and regulatory issues.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea medical society\u003c/strong\u003e\u0026nbsp;in connection with Senate committee investigations in payments to physicians.\u003c/p\u003e","\u003cp\u003eRepresented individuals in connection with House and Senate committee inquiries and ethics investigations.\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":3464}]},"expertise":[{"id":23,"guid":"23.capabilities","index":0,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":1,"source":"capabilities"},{"id":687,"guid":"687.smart_tags","index":2,"source":"smartTags"},{"id":111,"guid":"111.capabilities","index":3,"source":"capabilities"},{"id":1199,"guid":"1199.smart_tags","index":4,"source":"smartTags"},{"id":106,"guid":"106.capabilities","index":5,"source":"capabilities"},{"id":6,"guid":"6.capabilities","index":6,"source":"capabilities"},{"id":71,"guid":"71.capabilities","index":7,"source":"capabilities"},{"id":107,"guid":"107.capabilities","index":8,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":9,"source":"capabilities"},{"id":750,"guid":"750.smart_tags","index":10,"source":"smartTags"},{"id":761,"guid":"761.smart_tags","index":11,"source":"smartTags"},{"id":17,"guid":"17.capabilities","index":12,"source":"capabilities"},{"id":80,"guid":"80.capabilities","index":13,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":14,"source":"capabilities"},{"id":128,"guid":"128.capabilities","index":15,"source":"capabilities"},{"id":1261,"guid":"1261.smart_tags","index":16,"source":"smartTags"},{"id":1270,"guid":"1270.smart_tags","index":17,"source":"smartTags"}],"is_active":true,"last_name":"Donovan","nick_name":"Dan","clerkships":[],"first_name":"Daniel","title_rank":9999,"updated_by":202,"law_schools":[],"middle_name":"F.","name_suffix":"","recognitions":[{"title":"Band 1 Top Ranked Lawyer, Government Relations: Congressional Investigations - USA - Nationwide","detail":"Chambers USA, 2021-2024"},{"title":"“[Daniel] provides superb service and is an absolutely indispensable partner. He is incredibly responsive.”","detail":"Chambers USA"},{"title":"Tier 1 Government Relations: Congressional Investigations","detail":"Legal 500 US, 2024"},{"title":"“Life Sciences Star” White-Collar/Govt. Investigations","detail":"LMG Life Sciences, 2024"},{"title":"GIR 100","detail":"Global Investigations Review, 2024"},{"title":"Tier 1 for Government Relations Practice","detail":"Best Lawyers, 2024"},{"title":"“[W]e have complete confidence in his ability to manage complex issues and communicate with our senior leaders.”","detail":"Chambers USA"},{"title":"“King \u0026 Spalding is best known for its impressive congressional investigations practice.”","detail":"Chambers USA, 2008-2024"},{"title":"“Daniel is an expert in Congressional investigations and is always able to keep a calm head”","detail":"Chambers USA, 2021-2024"},{"title":"“Daniel provides extremely good insight into the Congressional process and can convey it to high-level executives.”","detail":"Chambers USA"},{"title":"“[A]ctive in high-profile congressional investigations, and includes ... experts such as Daniel Donovan”","detail":"Legal 500 US"},{"title":"King \u0026 Spalding has “a strong track in congressional investigations … Daniel Donovan is a key contact”","detail":"Legal 500 US"},{"title":"Nationwide Government Relations Practice Ranking","detail":"Chambers USA 2008-2024"},{"title":"Leading Government Relations Lawyer","detail":"Legal 500 US, 2020-2024"},{"title":"Crisis Management and Government Oversight Practice Award","detail":"National Law Journal 2021"},{"title":"“Law Firm of the Year” for Government Relations","detail":"US News \u0026 World Report"}],"linked_in_url":"https://www.linkedin.com/in/dan-donovan-214322a/","seodescription":"Dan Donovan specializes in congressional, state attorneys general and parallel government investigations. Read more about him.","primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eDan Donovan specializes in congressional, state attorneys general and parallel government investigations. A former Chief Investigative Counsel in the Senate, Dan co-chairs\u0026nbsp;our Government Advocacy and Congressional Investigations practices perennially recognized by \u003cem\u003eChambers USA\u003c/em\u003e: \u0026ldquo;King \u0026amp; Spalding is best known for its impressive congressional investigations practice, with several dedicated members working exclusively in this area.\u0026rdquo; Dan is ranked Band 1 for Congressional Investigations by \u003cem\u003eChambers USA \u003c/em\u003eand Tier 1 \u003cem\u003eLegal 500 US\u003c/em\u003e.\u0026nbsp; He\u0026nbsp;has two decades of crisis management experience with government investigations, involving significant legal, public relations and political risks.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003eDan represents leading companies, individuals, trade associations, and nonprofit entities and provides effective crisis management counsel. He works at the forefront of controversial and politicized national and state policy issues that frequently lead to investigations and litigation, including congressional, multi-state and federal agency enforcement actions. Particularly experienced in anticipating and responding to congressional committee requests and subpoenas, Dan prepares clients for high-profile hearings and guides them through the unique challenges presented by congressional and parallel government investigations.\u003c/p\u003e\n\u003cp\u003eBefore joining the firm, Dan served as Senior Investigative Counsel to Senator Charles Grassley, then Chairman of the Committee on Finance. While serving in the U.S. Senate, Dan managed congressional investigations and oversight hearings. In this role, Dan directed investigations focused on statutory and regulatory compliance, including drug and device safety, drug pricing, and waste, fraud and abuse in Medicare, Medicaid and other government programs. He also handled policy and legislative matters, including the False Claims Act, the Food, Drug, and Cosmetic Act, Medicare and Medicaid programs, and related statutes. Dan also served as Chief Investigative Counsel to the Senate Committee on Small Business, where he managed consumer fraud and small business protection investigations and hearings. He began his congressional career as a Staff Assistant on the Senate Committee on Governmental Affairs, chaired by Senator Fred Thompson, working on the special investigation into the 1996 federal election campaigns.\u003c/p\u003e\n\u003cp\u003eDan also provides strategic policy and legislative counsel, and is a frequent speaker on congressional oversight and investigations.\u003c/p\u003e","matters":["\u003cp\u003eExperience representing numerous clients under investigation by Republican-controlled Senate and House Committees, including Senate Banking, Commerce, Finance, HELP, Homeland Security, Judiciary, Permanent Subcommittee on Investigations, Special Committee on Aging, and House Education and the Workforce, Energy \u0026amp; Commerce, Financial Services, Judiciary, Oversight and Reform, Select Subcommittee on the Coronavirus Crisis, Select Committee on CCP, and Ways \u0026amp; Means, among others.\u003c/p\u003e","\u003cp\u003eProviding advice and counsel with respect to congressional oversight activity to leading companies in private sector industries, including accounting, auto, banking, consulting, defense, energy, fashion, food, healthcare provider, higher education, insurance, medical device, pharmaceutical, private equity, and tech, among others.\u003c/p\u003e","\u003cp\u003eRepresenting\u0026nbsp;\u003cstrong\u003ea variety of clients\u003c/strong\u003e\u0026nbsp;in connection with investigations relating to allegations of government fraud, food and product safety and recalls, cybersecurity breaches, product pricing, clinical research, off-label promotion, direct-to-consumer advertising, payments to physicians, and financial conflicts of interest.\u003c/p\u003e","\u003cp\u003eRepresenting\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003emultiple pharmaceutical companies\u003c/strong\u003e\u0026nbsp;in connection with congressional and state attorneys general drug pricing investigations.\u003c/p\u003e","\u003cp\u003eRepresenting\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea variety of clients\u003c/strong\u003e\u0026nbsp;on healthcare policy and legislative issues.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea major university\u003c/strong\u003e\u0026nbsp;and\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003epharmaceutical company\u003c/strong\u003e\u0026nbsp;in connection with the Select Panel on Infant Lives (authorized under the House Energy and Commerce Committee) investigation relating to fetal tissue research.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea global financial institution\u003c/strong\u003e\u0026nbsp;in connection with an investigation by the Senate Permanent Subcommittee on Investigations, regarding international tax matters.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea Big Four accounting firm\u003c/strong\u003e\u0026nbsp;in a Senate Finance Committee investigation of a University\u0026rsquo;s handling of federal funds.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003emultiple pharmaceutical companies\u003c/strong\u003e\u0026nbsp;in House and Senate investigations related to Affordable Care Act enactment and implementation.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003emedical device companies\u003c/strong\u003e\u0026nbsp;in connection with House and Senate committee investigations into 510(k) regulatory issues, direct-to-consumer advertising, and payments to physicians.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea leading clean energy technology company\u003c/strong\u003e\u0026nbsp;in connection with a Senate investigation into Department of Energy grant program.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea major oil company\u003c/strong\u003e\u0026nbsp;in connection with congressional investigations.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea health insurer\u003c/strong\u003e\u0026nbsp;in House and Senate investigations related to Affordable Care Act implementation.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea coalition of food product companies\u003c/strong\u003e\u0026nbsp;in connection with congressional inquiries relating to food safety and regulatory issues.\u003c/p\u003e","\u003cp\u003eRepresented\u0026nbsp;\u003cstrong data-redactor-tag=\"strong\"\u003ea medical society\u003c/strong\u003e\u0026nbsp;in connection with Senate committee investigations in payments to physicians.\u003c/p\u003e","\u003cp\u003eRepresented individuals in connection with House and Senate committee inquiries and ethics investigations.\u003c/p\u003e"],"recognitions":[{"title":"Band 1 Top Ranked Lawyer, Government Relations: Congressional Investigations - USA - Nationwide","detail":"Chambers USA, 2021-2024"},{"title":"“[Daniel] provides superb service and is an absolutely indispensable partner. He is incredibly responsive.”","detail":"Chambers USA"},{"title":"Tier 1 Government Relations: Congressional Investigations","detail":"Legal 500 US, 2024"},{"title":"“Life Sciences Star” White-Collar/Govt. 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He is incredibly responsive.”\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"Tier 1 Government Relations: Congressional Investigations\", :detail=\u0026gt;\"Legal 500 US, 2024\"}{{ FIELD }}{:title=\u0026gt;\"“Life Sciences Star” White-Collar/Govt. Investigations\", :detail=\u0026gt;\"LMG Life Sciences, 2024\"}{{ FIELD }}{:title=\u0026gt;\"GIR 100\", :detail=\u0026gt;\"Global Investigations Review, 2024\"}{{ FIELD }}{:title=\u0026gt;\"Tier 1 for Government Relations Practice\", :detail=\u0026gt;\"Best Lawyers, 2024\"}{{ FIELD }}{:title=\u0026gt;\"“[W]e have complete confidence in his ability to manage complex issues and communicate with our senior leaders.”\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"“King \u0026amp; Spalding is best known for its impressive congressional investigations practice.”\", :detail=\u0026gt;\"Chambers USA, 2008-2024\"}{{ FIELD }}{:title=\u0026gt;\"“Daniel is an expert in Congressional investigations and is always able to keep a calm head”\", :detail=\u0026gt;\"Chambers USA, 2021-2024\"}{{ FIELD }}{:title=\u0026gt;\"“Daniel provides extremely good insight into the Congressional process and can convey it to high-level executives.”\", :detail=\u0026gt;\"Chambers USA\"}{{ FIELD }}{:title=\u0026gt;\"“[A]ctive in high-profile congressional investigations, and includes ... experts such as Daniel Donovan”\", :detail=\u0026gt;\"Legal 500 US\"}{{ FIELD }}{:title=\u0026gt;\"King \u0026amp; Spalding has “a strong track in congressional investigations … Daniel Donovan is a key contact”\", :detail=\u0026gt;\"Legal 500 US\"}{{ FIELD }}{:title=\u0026gt;\"Nationwide Government Relations Practice Ranking\", :detail=\u0026gt;\"Chambers USA 2008-2024\"}{{ FIELD }}{:title=\u0026gt;\"Leading Government Relations Lawyer\", :detail=\u0026gt;\"Legal 500 US, 2020-2024\"}{{ FIELD }}{:title=\u0026gt;\"Crisis Management and Government Oversight Practice Award\", :detail=\u0026gt;\"National Law Journal 2021\"}{{ FIELD }}{:title=\u0026gt;\"“Law Firm of the Year” for Government Relations\", :detail=\u0026gt;\"US News \u0026amp; World Report\"}{{ FIELD }}Experience representing numerous clients under investigation by Republican-controlled Senate and House Committees, including Senate Banking, Commerce, Finance, HELP, Homeland Security, Judiciary, Permanent Subcommittee on Investigations, Special Committee on Aging, and House Education and the Workforce, Energy \u0026amp; Commerce, Financial Services, Judiciary, Oversight and Reform, Select Subcommittee on the Coronavirus Crisis, Select Committee on CCP, and Ways \u0026amp; Means, among others.{{ FIELD }}Providing advice and counsel with respect to congressional oversight activity to leading companies in private sector industries, including accounting, auto, banking, consulting, defense, energy, fashion, food, healthcare provider, higher education, insurance, medical device, pharmaceutical, private equity, and tech, among others.{{ FIELD }}Representing a variety of clients in connection with investigations relating to allegations of government fraud, food and product safety and recalls, cybersecurity breaches, product pricing, clinical research, off-label promotion, direct-to-consumer advertising, payments to physicians, and financial conflicts of interest.{{ FIELD }}Representing multiple pharmaceutical companies in connection with congressional and state attorneys general drug pricing investigations.{{ FIELD }}Representing a variety of clients on healthcare policy and legislative issues.{{ FIELD }}Represented a major university and pharmaceutical company in connection with the Select Panel on Infant Lives (authorized under the House Energy and Commerce Committee) investigation relating to fetal tissue research.{{ FIELD }}Represented a global financial institution in connection with an investigation by the Senate Permanent Subcommittee on Investigations, regarding international tax matters.{{ FIELD }}Represented a Big Four accounting firm in a Senate Finance Committee investigation of a University’s handling of federal funds.{{ FIELD }}Represented multiple pharmaceutical companies in House and Senate investigations related to Affordable Care Act enactment and implementation.{{ FIELD }}Represented medical device companies in connection with House and Senate committee investigations into 510(k) regulatory issues, direct-to-consumer advertising, and payments to physicians.{{ FIELD }}Represented a leading clean energy technology company in connection with a Senate investigation into Department of Energy grant program.{{ FIELD }}Represented a major oil company in connection with congressional investigations.{{ FIELD }}Represented a health insurer in House and Senate investigations related to Affordable Care Act implementation.{{ FIELD }}Represented a coalition of food product companies in connection with congressional inquiries relating to food safety and regulatory issues.{{ FIELD }}Represented a medical society in connection with Senate committee investigations in payments to physicians.{{ FIELD }}Represented individuals in connection with House and Senate committee inquiries and ethics investigations.{{ FIELD }}Dan Donovan specializes in congressional, state attorneys general and parallel government investigations. A former Chief Investigative Counsel in the Senate, Dan co-chairs our Government Advocacy and Congressional Investigations practices perennially recognized by Chambers USA: “King \u0026amp; Spalding is best known for its impressive congressional investigations practice, with several dedicated members working exclusively in this area.” Dan is ranked Band 1 for Congressional Investigations by Chambers USA and Tier 1 Legal 500 US.  He has two decades of crisis management experience with government investigations, involving significant legal, public relations and political risks.\nDan represents leading companies, individuals, trade associations, and nonprofit entities and provides effective crisis management counsel. He works at the forefront of controversial and politicized national and state policy issues that frequently lead to investigations and litigation, including congressional, multi-state and federal agency enforcement actions. Particularly experienced in anticipating and responding to congressional committee requests and subpoenas, Dan prepares clients for high-profile hearings and guides them through the unique challenges presented by congressional and parallel government investigations.\nBefore joining the firm, Dan served as Senior Investigative Counsel to Senator Charles Grassley, then Chairman of the Committee on Finance. While serving in the U.S. Senate, Dan managed congressional investigations and oversight hearings. In this role, Dan directed investigations focused on statutory and regulatory compliance, including drug and device safety, drug pricing, and waste, fraud and abuse in Medicare, Medicaid and other government programs. He also handled policy and legislative matters, including the False Claims Act, the Food, Drug, and Cosmetic Act, Medicare and Medicaid programs, and related statutes. Dan also served as Chief Investigative Counsel to the Senate Committee on Small Business, where he managed consumer fraud and small business protection investigations and hearings. He began his congressional career as a Staff Assistant on the Senate Committee on Governmental Affairs, chaired by Senator Fred Thompson, working on the special investigation into the 1996 federal election campaigns.\nDan also provides strategic policy and legislative counsel, and is a frequent speaker on congressional oversight and investigations. Daniel Donovan lawyer Partner Band 1 Top Ranked Lawyer, Government Relations: Congressional Investigations - USA - Nationwide Chambers USA, 2021-2024 “[Daniel] provides superb service and is an absolutely indispensable partner. He is incredibly responsive.” Chambers USA Tier 1 Government Relations: Congressional Investigations Legal 500 US, 2024 “Life Sciences Star” White-Collar/Govt. Investigations LMG Life Sciences, 2024 GIR 100 Global Investigations Review, 2024 Tier 1 for Government Relations Practice Best Lawyers, 2024 “[W]e have complete confidence in his ability to manage complex issues and communicate with our senior leaders.” Chambers USA “King \u0026amp; Spalding is best known for its impressive congressional investigations practice.” Chambers USA, 2008-2024 “Daniel is an expert in Congressional investigations and is always able to keep a calm head” Chambers USA, 2021-2024 “Daniel provides extremely good insight into the Congressional process and can convey it to high-level executives.” Chambers USA “[A]ctive in high-profile congressional investigations, and includes ... experts such as Daniel Donovan” Legal 500 US King \u0026amp; Spalding has “a strong track in congressional investigations … Daniel Donovan is a key contact” Legal 500 US Nationwide Government Relations Practice Ranking Chambers USA 2008-2024 Leading Government Relations Lawyer Legal 500 US, 2020-2024 Crisis Management and Government Oversight Practice Award National Law Journal 2021 “Law Firm of the Year” for Government Relations US News \u0026amp; World Report University of Rochester  American University Washington College of Law District of Columbia Maryland Experience representing numerous clients under investigation by Republican-controlled Senate and House Committees, including Senate Banking, Commerce, Finance, HELP, Homeland Security, Judiciary, Permanent Subcommittee on Investigations, Special Committee on Aging, and House Education and the Workforce, Energy \u0026amp; Commerce, Financial Services, Judiciary, Oversight and Reform, Select Subcommittee on the Coronavirus Crisis, Select Committee on CCP, and Ways \u0026amp; Means, among others. Providing advice and counsel with respect to congressional oversight activity to leading companies in private sector industries, including accounting, auto, banking, consulting, defense, energy, fashion, food, healthcare provider, higher education, insurance, medical device, pharmaceutical, private equity, and tech, among others. Representing a variety of clients in connection with investigations relating to allegations of government fraud, food and product safety and recalls, cybersecurity breaches, product pricing, clinical research, off-label promotion, direct-to-consumer advertising, payments to physicians, and financial conflicts of interest. Representing multiple pharmaceutical companies in connection with congressional and state attorneys general drug pricing investigations. Representing a variety of clients on healthcare policy and legislative issues. Represented a major university and pharmaceutical company in connection with the Select Panel on Infant Lives (authorized under the House Energy and Commerce Committee) investigation relating to fetal tissue research. Represented a global financial institution in connection with an investigation by the Senate Permanent Subcommittee on Investigations, regarding international tax matters. Represented a Big Four accounting firm in a Senate Finance Committee investigation of a University’s handling of federal funds. Represented multiple pharmaceutical companies in House and Senate investigations related to Affordable Care Act enactment and implementation. Represented medical device companies in connection with House and Senate committee investigations into 510(k) regulatory issues, direct-to-consumer advertising, and payments to physicians. Represented a leading clean energy technology company in connection with a Senate investigation into Department of Energy grant program. Represented a major oil company in connection with congressional investigations. Represented a health insurer in House and Senate investigations related to Affordable Care Act implementation. Represented a coalition of food product companies in connection with congressional inquiries relating to food safety and regulatory issues. Represented a medical society in connection with Senate committee investigations in payments to physicians. Represented individuals in connection with House and Senate committee inquiries and ethics investigations.","searchable_name":"Daniel F. Donovan (Dan)","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":431883,"version":1,"owner_type":"Person","owner_id":3969,"payload":{"bio":"\u003cp\u003eA partner in our FDA and Life Sciences practice, Lisa has almost 25\u0026nbsp;years of experience developing regulatory, legislative and litigation solutions for companies selling FDA-regulated products (i.e., drugs, devices, biologics, cosmetics, and tobacco). \u0026nbsp;She has served as an advisor to high-level public officials and C-suite executives on complex regulatory, policy, and litigation issues.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePreviously, Lisa served as a Senior Policy Advisor in the FDA Commissioner\u0026rsquo;s Office and as the Deputy Chief of Staff to the Commissioner of Food and Drugs. In these roles, she provided strategic counsel on the agency\u0026rsquo;s most significant and complex issues. These included off-label marketing, mobile medical apps/digital health, opioid misuse and abuse, in vitro diagnostics and next generation sequencing, cosmetic legislation and regulation, and antimicrobial drug development and use. During her tenure at the FDA, she also worked closely with Congress, the Department of Health and Human Services, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Drug Enforcement Administration (DEA).\u003c/p\u003e\n\u003cp\u003eLisa is a frequent author and speaker on topics including:\u0026nbsp; digital health, advertising and promoting drugs and devices, remedying unfair competition in the drug and device space, women\u0026rsquo;s health issues, admissibility of 510(k)s in product liability lawsuits, preemption, in vitro diagnostics, the 21st Century Cures Act, and other topics. Lisa is Chambers ranked for Pharmaceutical/Medical Products Law. She also has been repeatedly recognized by Legal 500 as a Next Generation Partner and as a Recommended Key Lawyer for FDA Regulatory Law (2017, 2019, 2020, 2021, 2022, 2023, 2024) and for Government Relations (2016). Legal 500 has distinguished her for her expertise in digital health/AI and in pre-market strategies, and praised for her \u0026ldquo;unending enthusiasm to take on client\u0026rsquo;s causes as her own.\"\u003c/p\u003e","slug":"lisa-dwyer","email":"ldwyer@kslaw.com","phone":null,"matters":["\u003cp\u003eFocus on Digital Health/Telehealth\u003c/p\u003e","\u003cp\u003eFocus on In Vitro Diagnostic Tests and Laboratory Developed Tests\u003c/p\u003e","\u003cp\u003eFDA/FTC regulation of advertising and promotion\u003c/p\u003e","\u003cp\u003ePre-market development (drugs and devices (including digital health products))\u003c/p\u003e","\u003cp\u003eFDA product submissions (drugs and devices (including digital health products))\u003c/p\u003e","\u003cp\u003eDevelops regulatory, legislative and litigation solutions for unfair competition in the drug/device space\u003c/p\u003e\n\u003cp\u003e- Lanham Act\u003c/p\u003e\n\u003cp\u003e- Unfair trade practice statutes (state and federal)\u003c/p\u003e","\u003cp\u003eEngages FDA and Congress on key issues related to FDA-regulated products\u003c/p\u003e","\u003cp\u003eResponds to FDA/FTC inquires, FDA warning letters, and FDA 483s\u003c/p\u003e","\u003cp\u003eExperience remedying cGMP issues at facilities making OTC and Rx drugs and cosmetics\u003c/p\u003e","\u003cp\u003eCo-Chairs Women's Health Initiative\u003c/p\u003e","\u003cp\u003eMember of Cannabis Steering Committee\u003c/p\u003e"],"taggings":{"tags":[],"meta_tags":[{"id":53}]},"expertise":[{"id":2,"guid":"2.capabilities","index":0,"source":"capabilities"},{"id":3,"guid":"3.smart_tags","index":1,"source":"smartTags"},{"id":23,"guid":"23.capabilities","index":2,"source":"capabilities"},{"id":81,"guid":"81.capabilities","index":3,"source":"capabilities"},{"id":103,"guid":"103.capabilities","index":4,"source":"capabilities"},{"id":21,"guid":"21.capabilities","index":5,"source":"capabilities"},{"id":970,"guid":"970.smart_tags","index":6,"source":"smartTags"},{"id":112,"guid":"112.capabilities","index":7,"source":"capabilities"},{"id":122,"guid":"122.capabilities","index":8,"source":"capabilities"},{"id":1193,"guid":"1193.smart_tags","index":9,"source":"smartTags"},{"id":1202,"guid":"1202.smart_tags","index":10,"source":"smartTags"},{"id":1206,"guid":"1206.smart_tags","index":11,"source":"smartTags"},{"id":1223,"guid":"1223.smart_tags","index":12,"source":"smartTags"},{"id":133,"guid":"133.capabilities","index":13,"source":"capabilities"}],"is_active":true,"last_name":"Dwyer","nick_name":"Lisa","clerkships":[],"first_name":"Lisa","title_rank":9999,"updated_by":202,"law_schools":[{"id":753,"meta":{"degree":"J.D.","honors":"honors","is_law_school":"1","graduation_date":"1998-01-01 00:00:00"},"order":1,"pin_order":null,"pin_expiration":null}],"middle_name":"M.","name_suffix":"","recognitions":[{"title":"Next Generation Lawyer","detail":"Legal 500, 2017 and 2019"},{"title":"Recognition for Government Relations ","detail":"Legal 500, 2016"},{"title":"FDA Commissioner’s Special Citation, Issuance of the Draft Guidance for Laboratory Developed Tests ","detail":"FDA Award Ceremony, 2015"},{"title":"FDA Group Recognition Award, Publishing FDA Strategic Priorities 2014–2018 Document","detail":"FDA Award Ceremony, 2015"},{"title":"FDA Commissioner’s Special Citation, Issuance of the Unique Device Identification (UDI) System Final Rule ","detail":"FDA Award Ceremony, 2014"},{"title":"FDA Group Recognition Award, FDA Language Access Plan Working Group","detail":"FDA Award Ceremony, 2014"},{"title":"FDA Group Recognition Award, Good Guidance Practices-Best Practices Working Group (Group Leader)","detail":"FDA Award Ceremony, 2012"},{"title":"FDA Group Recognition Award, Menu Labeling Working Group","detail":"CFSAN/FDA Award Ceremony, 2011"}],"linked_in_url":null,"seodescription":null,"primary_title_id":15,"translated_fields":{"en":{"bio":"\u003cp\u003eA partner in our FDA and Life Sciences practice, Lisa has almost 25\u0026nbsp;years of experience developing regulatory, legislative and litigation solutions for companies selling FDA-regulated products (i.e., drugs, devices, biologics, cosmetics, and tobacco). \u0026nbsp;She has served as an advisor to high-level public officials and C-suite executives on complex regulatory, policy, and litigation issues.[[--readmore--]]\u003c/p\u003e\n\u003cp\u003ePreviously, Lisa served as a Senior Policy Advisor in the FDA Commissioner\u0026rsquo;s Office and as the Deputy Chief of Staff to the Commissioner of Food and Drugs. In these roles, she provided strategic counsel on the agency\u0026rsquo;s most significant and complex issues. These included off-label marketing, mobile medical apps/digital health, opioid misuse and abuse, in vitro diagnostics and next generation sequencing, cosmetic legislation and regulation, and antimicrobial drug development and use. During her tenure at the FDA, she also worked closely with Congress, the Department of Health and Human Services, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Drug Enforcement Administration (DEA).\u003c/p\u003e\n\u003cp\u003eLisa is a frequent author and speaker on topics including:\u0026nbsp; digital health, advertising and promoting drugs and devices, remedying unfair competition in the drug and device space, women\u0026rsquo;s health issues, admissibility of 510(k)s in product liability lawsuits, preemption, in vitro diagnostics, the 21st Century Cures Act, and other topics. Lisa is Chambers ranked for Pharmaceutical/Medical Products Law. She also has been repeatedly recognized by Legal 500 as a Next Generation Partner and as a Recommended Key Lawyer for FDA Regulatory Law (2017, 2019, 2020, 2021, 2022, 2023, 2024) and for Government Relations (2016). Legal 500 has distinguished her for her expertise in digital health/AI and in pre-market strategies, and praised for her \u0026ldquo;unending enthusiasm to take on client\u0026rsquo;s causes as her own.\"\u003c/p\u003e","matters":["\u003cp\u003eFocus on Digital Health/Telehealth\u003c/p\u003e","\u003cp\u003eFocus on In Vitro Diagnostic Tests and Laboratory Developed Tests\u003c/p\u003e","\u003cp\u003eFDA/FTC regulation of advertising and promotion\u003c/p\u003e","\u003cp\u003ePre-market development (drugs and devices (including digital health products))\u003c/p\u003e","\u003cp\u003eFDA product submissions (drugs and devices (including digital health products))\u003c/p\u003e","\u003cp\u003eDevelops regulatory, legislative and litigation solutions for unfair competition in the drug/device space\u003c/p\u003e\n\u003cp\u003e- Lanham Act\u003c/p\u003e\n\u003cp\u003e- Unfair trade practice statutes (state and federal)\u003c/p\u003e","\u003cp\u003eEngages FDA and Congress on key issues 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2014"},{"title":"FDA Group Recognition Award, FDA Language Access Plan Working Group","detail":"FDA Award Ceremony, 2014"},{"title":"FDA Group Recognition Award, Good Guidance Practices-Best Practices Working Group (Group Leader)","detail":"FDA Award Ceremony, 2012"},{"title":"FDA Group Recognition Award, Menu Labeling Working Group","detail":"CFSAN/FDA Award Ceremony, 2011"}]},"locales":["en"]},"secondary_title_id":null,"upload_assignments":{"headshot":[{"id":11487}]},"capability_group_id":2},"created_at":"2025-07-09T20:54:25.000Z","updated_at":"2025-07-09T20:54:25.000Z","searchable_text":"Dwyer{{ FIELD }}{:title=\u0026gt;\"Next Generation Lawyer\", :detail=\u0026gt;\"Legal 500, 2017 and 2019\"}{{ FIELD }}{:title=\u0026gt;\"Recognition for Government Relations \", :detail=\u0026gt;\"Legal 500, 2016\"}{{ FIELD }}{:title=\u0026gt;\"FDA Commissioner’s Special Citation, Issuance of the Draft Guidance for Laboratory Developed Tests \", :detail=\u0026gt;\"FDA Award Ceremony, 2015\"}{{ FIELD }}{:title=\u0026gt;\"FDA Group Recognition Award, Publishing FDA Strategic Priorities 2014–2018 Document\", :detail=\u0026gt;\"FDA Award Ceremony, 2015\"}{{ FIELD }}{:title=\u0026gt;\"FDA Commissioner’s Special Citation, Issuance of the Unique Device Identification (UDI) System Final Rule \", :detail=\u0026gt;\"FDA Award Ceremony, 2014\"}{{ FIELD }}{:title=\u0026gt;\"FDA Group Recognition Award, FDA Language Access Plan Working Group\", :detail=\u0026gt;\"FDA Award Ceremony, 2014\"}{{ FIELD }}{:title=\u0026gt;\"FDA Group Recognition Award, Good Guidance Practices-Best Practices Working Group (Group Leader)\", :detail=\u0026gt;\"FDA Award Ceremony, 2012\"}{{ FIELD }}{:title=\u0026gt;\"FDA Group Recognition Award, Menu Labeling Working Group\", :detail=\u0026gt;\"CFSAN/FDA Award Ceremony, 2011\"}{{ FIELD }}Focus on Digital Health/Telehealth{{ FIELD }}Focus on In Vitro Diagnostic Tests and Laboratory Developed Tests{{ FIELD }}FDA/FTC regulation of advertising and promotion{{ FIELD }}Pre-market development (drugs and devices (including digital health products)){{ FIELD }}FDA product submissions (drugs and devices (including digital health products)){{ FIELD }}Develops regulatory, legislative and litigation solutions for unfair competition in the drug/device space\n- Lanham Act\n- Unfair trade practice statutes (state and federal){{ FIELD }}Engages FDA and Congress on key issues related to FDA-regulated products{{ FIELD }}Responds to FDA/FTC inquires, FDA warning letters, and FDA 483s{{ FIELD }}Experience remedying cGMP issues at facilities making OTC and Rx drugs and cosmetics{{ FIELD }}Co-Chairs Women's Health Initiative{{ FIELD }}Member of Cannabis Steering Committee{{ FIELD }}A partner in our FDA and Life Sciences practice, Lisa has almost 25 years of experience developing regulatory, legislative and litigation solutions for companies selling FDA-regulated products (i.e., drugs, devices, biologics, cosmetics, and tobacco).  She has served as an advisor to high-level public officials and C-suite executives on complex regulatory, policy, and litigation issues.\nPreviously, Lisa served as a Senior Policy Advisor in the FDA Commissioner’s Office and as the Deputy Chief of Staff to the Commissioner of Food and Drugs. In these roles, she provided strategic counsel on the agency’s most significant and complex issues. These included off-label marketing, mobile medical apps/digital health, opioid misuse and abuse, in vitro diagnostics and next generation sequencing, cosmetic legislation and regulation, and antimicrobial drug development and use. During her tenure at the FDA, she also worked closely with Congress, the Department of Health and Human Services, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Drug Enforcement Administration (DEA).\nLisa is a frequent author and speaker on topics including:  digital health, advertising and promoting drugs and devices, remedying unfair competition in the drug and device space, women’s health issues, admissibility of 510(k)s in product liability lawsuits, preemption, in vitro diagnostics, the 21st Century Cures Act, and other topics. Lisa is Chambers ranked for Pharmaceutical/Medical Products Law. She also has been repeatedly recognized by Legal 500 as a Next Generation Partner and as a Recommended Key Lawyer for FDA Regulatory Law (2017, 2019, 2020, 2021, 2022, 2023, 2024) and for Government Relations (2016). Legal 500 has distinguished her for her expertise in digital health/AI and in pre-market strategies, and praised for her “unending enthusiasm to take on client’s causes as her own.\" Lisa M Dwyer Partner Next Generation Lawyer Legal 500, 2017 and 2019 Recognition for Government Relations  Legal 500, 2016 FDA Commissioner’s Special Citation, Issuance of the Draft Guidance for Laboratory Developed Tests  FDA Award Ceremony, 2015 FDA Group Recognition Award, Publishing FDA Strategic Priorities 2014–2018 Document FDA Award Ceremony, 2015 FDA Commissioner’s Special Citation, Issuance of the Unique Device Identification (UDI) System Final Rule  FDA Award Ceremony, 2014 FDA Group Recognition Award, FDA Language Access Plan Working Group FDA Award Ceremony, 2014 FDA Group Recognition Award, Good Guidance Practices-Best Practices Working Group (Group Leader) FDA Award Ceremony, 2012 FDA Group Recognition Award, Menu Labeling Working Group CFSAN/FDA Award Ceremony, 2011 Wesleyan University  George Washington University George Washington University Law School District of Columbia Massachusetts Pennsylvania Focus on Digital Health/Telehealth Focus on In Vitro Diagnostic Tests and Laboratory Developed Tests FDA/FTC regulation of advertising and promotion Pre-market development (drugs and devices (including digital health products)) FDA product submissions (drugs and devices (including digital health products)) Develops regulatory, legislative and litigation solutions for unfair competition in the drug/device space\n- Lanham Act\n- Unfair trade practice statutes (state and federal) Engages FDA and Congress on key issues related to FDA-regulated products Responds to FDA/FTC inquires, FDA warning letters, and FDA 483s Experience remedying cGMP issues at facilities making OTC and Rx drugs and cosmetics Co-Chairs Women's Health Initiative Member of Cannabis Steering Committee","searchable_name":"Lisa M. 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Counsel Harvard University Harvard Law School Harvard University Harvard Law School U.S. Court of Appeals for the Third Circuit U.S. District Court for the District of New Jersey New Jersey New York Law Clerk, Hon. Joseph A. Greenaway, Jr., U.S. Court of Appeals for the Third Circuit","searchable_name":"Justin Dews","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}]}}