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Advertising Drugs and Health Care Products via Social Media: FDA Regulation


Product Code - LGN252
Speaker(s): Jeffrey K. Francer, Pharmaceutical Research and Manufacturers of America (PhRMA); Stefanie A. Doebler, Covington & Burling LLP; Saurabh Anand, Covington & Burling LLP
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The Internet and social media are a growing source of medical information, and health care providers and patients are turning to online sources more often than ever. Likewise, advertising and promotion via the Internet and on social media platforms appears to be increasing.

The U.S. Food and Drug Administration (FDA) is tasked with regulating the “advertising” and “labeling” of certain drugs, devices, and biologics. Since 2009, the agency has been engaged in developing guidance to address promotional activities on social media. The FDA’s enforcement actions in this area have been grounded in the same principles that it applies to promotion using “traditional” media such as TV ads, magazines, and brochures. Until recently, the FDA has provided only limited guidance on the unique issues raised by the interactive and interconnected nature of social media.

How the FDA regulates the use of social media is of key importance for firms contributing content to social media platforms or providing social media forums for third parties. In some cases, statements made on social media, even if not authored by the firm, may subject the firm’s products to FDA regulation or enforcement. And, even if a firm does not directly participate in social media, it may face risks from employees’ and consultants’ actions on social media. Attend this program to learn about FDA regulation in this area and how to keep your clients compliant.

Educational Objectives:

• Understand the regulatory scheme and the FDA’s policy surrounding advertising and promotion via social media.
• Learn about the implications of FDA enforcement actions relating to social media on advertising and marketing operations.
• Identify the open questions relating to FDA’ regulation of advertising and promotion on social media.

Who would benefit most from attending this program?

Counsel advising pharmaceutical, biologic, and medical device manufacturers engaged in advertising and promotion of their products; attorneys specializing in food and drug issues and regulations; those involved in the life sciences industry.

Program Level: Intermediate
Prerequisite: A general understanding of health care regulation.
CPE Delivery Method: Group Internet-Based Live
Field of Study: Specialized Knowledge and Applications
Recommended CPE Credit: 1.0 credit
Anticipated CLE Credit: 1.0 credit (may vary based on from which jurisdiction requested)

For additional information, please see the “CE Credit” tab.

Jeffrey K. Francer, Pharmaceutical Research and Manufacturers of America (PhRMA); Stefanie A. Doebler, Covington & Burling LLP; Saurabh Anand, Covington & Burling LLP

Jeffrey K. Francer, Pharmaceutical Research and Manufacturers of America (PhRMA)
Jeff Francer is Vice President and Senior Counsel at PhRMA and serves as principal counsel to the association on issues relating to the research, development, and regulation of medicines in the U.S. and globally. Prior to joining PhRMA, Mr. Francer served as Associate Chief Counsel of the FDA and as a regulatory attorney for biopharmaceutical companies.

Mr. Francer earned a J.D. from the University of Virginia School of Law and also graduated from Harvard University's Kennedy School of Government and from Brown University.

Stefanie A. Doebler, Covington & Burling LLP
Stefanie Doebler is special counsel in Covington & Burling’s health care and food and drug practice groups. Her practice focuses on health care compliance matters for pharmaceutical and medical device clients, including advertising and promotion, fraud and abuse, reimbursement, and aggregate spend reporting. Ms. Doebler clerked for the Hon. Ronald Lee Gilman of the U.S. Court of Appeals for the Sixth Circuit.

Ms. Doebler earned a J.D., cum laude, from the University of Michigan Law School, where she served as Executive Note Editor of the Michigan Law Review; an M.P.H. from the University of Michigan School of Public Health; an M.A. from Carnegie Mellon University; and a B.A., with honors, from Northwestern University. She is admitted to practice in the District of Columbia and Pennsylvania.

Saurabh Anand, Covington & Burling LLP
Saurabh Anand is an associate in Covington & Burling’s Food & Drug practice group, practicing from the firm’s Washington, D.C. office. He regularly advises clients on advertising and promotion issues as well as aerospace, pharmaceutical, and medical device clients on a range of regulatory, government contract, and intellectual property issues. Mr. Anand clerked for the Hon. Stephen V. Wilson of the U.S. District Court for the Central District of California.

Mr. Anand earned a J.D. from the University of Southern California Gould School of Law, where he was a member of the Order of the Coif and served as Senior Submissions Editor for the University of Southern California Law Review, and a B.S., magna cum laude, from Washington University in St. Louis. He is admitted to practice in California and the District of Columbia.

This program’s CLE-credit eligibility varies by state. Bloomberg BNA is an accredited provider in the states of New York*, California, Pennsylvania, Texas and Virginia, and most other jurisdictions grant CLE credit on a per-program basis. At this time, Bloomberg BNA does not apply directly to the states of Florida, Rhode Island, Montana and Hawaii although credit is usually available for attorneys who wish to apply individually. Additionally, the following states currently do not grant credit for Bloomberg BNA OnDemand programming: Arkansas, Ohio, Nebraska, and Delaware. All requests are subject to approval once the live webinar has taken place or the customer has viewed the OnDemand version. Please contact the Bloomberg BNA accreditations desk if you have specific questions that have not been addressed.

*Bloomberg BNA is an accredited provider in New York for experienced attorneys only.

Hardship Policy
For information regarding Bloomberg BNA’s Hardship Policy, please visit the Continuing Education Information page.

Questions
Individual programs, subjects, and formats may not receive credit in some states and there may be specific rules regarding who may earn credit or the maximum number of credit hours that may be earned with specific formats. For specific questions, contact your state MCLE regulatory entity for specific questions about your MCLE rules or visit the American Bar Association’s website for general information on accreditation.

If you have further questions regarding a specific state or how to file for CE credit, please contact Bloomberg BNA customer service at 800-372-1033 and ask to speak to the CLE Accreditation Coordinator or send an email to accreditations@bna.com.