This e-alert is part of a series of e-alerts summarizing publicly available FDA enforcement letters (i.e., warning letters and untitled letters) relating to the advertising and promotion of prescription drugs, medical devices, and biologics.

Click here to read the full alert on cov.com.

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Photo of Scott Cunningham Scott Cunningham

Scott Cunningham is a member of the firm’s Food and Drug practice group.  He represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the FDA, Congress, state and federal courts, and other regulatory and enforcement agencies.  Scott …

Scott Cunningham is a member of the firm’s Food and Drug practice group.  He represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the FDA, Congress, state and federal courts, and other regulatory and enforcement agencies.  Scott has significant experience in areas including new product development and clinical trials; IRBs; new product approvals; Hatch-Waxman exclusivities and product life-cycle management; advertising and promotion; False Claims Act and Anti-Kickback compliance issues and pharmaceutical investigations; Orphan Drug; pediatric exclusivity; manufacturing and cGMPs; import/export; controlled substances; SEC disclosure; and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.

Scott also has an active pro bono practice where he regularly serves as a Guardian ad Litem representing children in neglect & abuse and child custody cases.

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Photo of Scott Danzis Scott Danzis

Scott Danzis is a partner in Covington’s Food, Drug, and Device Practice Group and chairs the Firm’s Medical Device Industry Group. Scott is a leading expert on the regulation of medical devices, diagnostics, and digital health. He regularly helps clients navigate their most…

Scott Danzis is a partner in Covington’s Food, Drug, and Device Practice Group and chairs the Firm’s Medical Device Industry Group. Scott is a leading expert on the regulation of medical devices, diagnostics, and digital health. He regularly helps clients navigate their most complex regulatory challenges, including strategies for premarket review, postmarket compliance, and enforcement actions. Scott counsels many of the world’s preeminent medical device companies on a range of matters, including advertising and promotion, recalls, quality system issues, medical device reporting, clinical and non-clinical testing, FDA inspections, and other regulatory matters.

Scott previously served in FDA’s Office of the Chief Counsel where he served as the Special Assistant to the Chief Counsel of FDA. At FDA, Scott was involved in a wide range of legal and regulatory matters, including significant rulemaking, enforcement actions, and legislative initiatives.

Scott speaks regularly at conferences regarding FDA regulation of devices and diagnostics, and since 2010 serves as an Adjunct Professor of Law at the Georgetown University Law Center, where he teaches a course on FDA law.

Scott is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review and elected to the Order of Coif. He also holds a Master’s Degree from George Washington University and a Bachelor of Science from Cornell University.

From 2006 to 2008, Scott served as the Special Assistant to the Chief Counsel of the U.S. Food and Drug Administration. While at FDA, he was broadly involved in a wide range of legal and regulatory matters related to medical devices and drugs. He also worked on implementing key provisions of the Food and Drug Administration Amendments Act of 2007.

Scott has significant experience in the following areas:

FDA regulatory strategies, including strategies for the premarket review (510(k)s, PMAs) of medical devices;
Appeals and dispute resolution within FDA;
IDEs, INDs, and clinical trial regulation;
Advertising, promotion, and scientific exchange, including responding to enforcement actions and investigations;
Imports and exports of FDA regulated products;
QSR and cGMP requirements, including responding to FDA 483s and enforcement actions;
Product recalls;
Adverse event and MDR reporting;
FDA consent decrees and OIG corporate integrity agreements;
Regulatory due diligence;
Compliance with antifraud statutes, including the anti-kickback statute and the False Claims Act.

Scott recently developed and edited a book on the regulation of in vitro diagnostic products and laboratory testing, In Vitro Diagnostics: The Complete Regulatory Guide (FDLI, 2010). He currently serves as an Adjunct Professor at the Georgetown University Law Center where he teaches a course on the regulation of drugs, biologics, and medical devices.

Scott clerked for the Honorable Chester J. Straub on the U.S. Court of Appeals for the Second Circuit. He is a graduate of the University of Virginia School of Law where he was the Editor-in-Chief of the Virginia Law Review and elected to the Order of the Coif. He holds a Masters Degree from George Washington University in Health Care Management and Policy, and a Bachelor of Science from Cornell University.

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Photo of Stefanie Doebler Stefanie Doebler

Stefanie Doebler is co-chair of the firm’s Health Care Practice Group, and a member of the Food, Drug, and Device Practice Group. Her practice focuses on health care compliance matters for pharmaceutical, biotech, and medical device clients. She provides advice related to advertising…

Stefanie Doebler is co-chair of the firm’s Health Care Practice Group, and a member of the Food, Drug, and Device Practice Group. Her practice focuses on health care compliance matters for pharmaceutical, biotech, and medical device clients. She provides advice related to advertising and promotion, fraud and abuse, transparency requirements, state law compliance and reporting regulations, interactions with health care professionals, Medicaid price reporting, and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices. Stefanie also advises on the development and implementation of health care compliance programs.

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Photo of Michael Labson Michael Labson

Mike Labson has been a trusted advisor to pharmaceutical and biotechnology clients for 30 years. He draws on his wide range of regulatory expertise to provide strategic and compliance advice, and address FDA and other health care law issues in transactions, litigation, and…

Mike Labson has been a trusted advisor to pharmaceutical and biotechnology clients for 30 years. He draws on his wide range of regulatory expertise to provide strategic and compliance advice, and address FDA and other health care law issues in transactions, litigation, and investigations.

Mike is the managing partner of the Boston office and co-chairs the firm’s global Life Sciences practice. He previously served in a number of firm leadership positions, including as a member of the firm’s Management Committee and Executive Committee.

Mike provides creative and practical solutions to biopharmaceutical clients large and small across critical regulatory areas. He actively advises on:

Clinical trial programs, including study subject recruitment, informed consent, good clinical practice conduct issues, and expanded access.
Regulatory approval strategies, including FDA expedited approval programs, FDA advisory committee preparation, and drug/device and drug/diagnostic approvals.
FDA dispute resolution.
Orphan drug, pediatric, and Hatch-Waxman exclusivity, and generic drug and biosimilar product approval standards.
Product promotion, payer, and scientific exchange communications.
Company post-approval activities, including REMS, pharmacovigilance, required post-marketing studies, and NDA and BLA changes.
Rx-to-OTC drug switches and OTC drug claims.
DEA requirements for controlled substances.

Mike’s pro bono work focuses on criminal justice matters. He is on the Emeritus Board of the Children’s Law Center and previously served as the Vice Chair of the Children’s Dental Health Project. Mike has also been an Adjunct Professor of Law at the American University Washington College of Law, and is a Fellow of the American Bar Foundation.

Mike is Band 1 in Chambers Global and Chambers USA for Pharmaceutical/Medical Products Regulatory and Life Sciences Regulatory/Compliance. He is also recognized in The Best Lawyers in America, Washington DC Super Lawyers, and LMG Life Sciences, where he was the Life Sciences Attorney of the Year in 2016.

As one reviewer in Chambers stated, “Michael is the dean of the food and drug bar. He is really smart and understands the whole act. I take comfort knowing that I can call Michael for an enterprise-level ‘above the fray’ view.”

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Photo of Christina Kuhn Christina Kuhn

Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.…

Christina Kuhn advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products.

Christina frequently helps multinational device manufacturers as well as start-up device companies navigate the premarket regulatory process, advising companies on regulatory classification, clinical development strategy, and agency interactions. She also has significant experience counseling medical device companies on postmarket compliance requirements, including those related to advertising and promotion, quality systems and manufacturing, medical device reporting, registration and listing, and recalls. She advises clients on responding to and resolving enforcement actions, such as FDA inspections and Warning Letters as well as Department of Justice investigations.

Christina advises clients on, and performs regulatory due diligence for, corporate transactions, including acquisitions, public offerings, co-development agreements, and clinical trial agreements.

Christina also regularly assists industry associations and medical device and pharmaceutical companies in commenting on FDA guidance documents and rulemaking as well as drafting and analyzing federal legislation.

Christina is a frequent contributor to Covington’s Digital Health and InsideMedicalDevices blogs.

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Photo of Beth Braiterman Beth Braiterman

Beth Braiterman is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device and Health Care Practice Groups. She advises pharmaceutical, biotechnology, medical device, and food companies on a variety of regulatory and compliance…

Beth Braiterman is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device and Health Care Practice Groups. She advises pharmaceutical, biotechnology, medical device, and food companies on a variety of regulatory and compliance issues.

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Photo of Sophie DeBode Sophie DeBode

Sophie DeBode is an associate in the firm’s Washington, DC office where she is a member of the Food, Drug, and Device Practice Group. Sophie advises food and beverage companies in a variety of product areas, including conventional food and dietary supplements, on…

Sophie DeBode is an associate in the firm’s Washington, DC office where she is a member of the Food, Drug, and Device Practice Group. Sophie advises food and beverage companies in a variety of product areas, including conventional food and dietary supplements, on regulatory and compliance issues. She counsels clients on product labeling and claim substantiation concerns to mitigate regulatory and litigation risks. Sophie also advises pharmaceutical, biotechnology, and medical device companies on various regulatory matters.

 

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