This annual event brings together the regulated industries and the regulators responsible for overseeing the advertising and promotion of prescription drugs, medical devices, biologics, and animal drugs. Attendees will keep abreast of the current issues, laws, new guidance documents, and recommendations for approaching the gray areas of medical products advertising and promotion. This interactive conference will provide both a broad and deep understanding of how to advertise and promote in a highly regulated environment, offer practical takeaways through informative panel discussions, case studies, and networking opportunities as you learn from industry experts and peers. Representatives from all four of the Food & Drug Administration’s (FDA) medical product centers will also provide the latest information on policy developments, enforcement activity, and future initiatives. Attendees will have the opportunity to engage with FDA, ask questions, and learn valuable takeaways.
Last Year’s Agenda
Registration and Continental Breakfast
FDLI Welcome and Announcements
Updates from the FDA Centers
Representatives from FDA’s Medical Products Centers will provide updates on the latest policy developments, enforcement actions, and the future of FDA’s oversight activities related to the advertising and promotion of drug, biologic, medical device, and veterinary medicine products. This session will lay the foundation for the conference and provide FDA’s current thinking on important issues raised by industry.
Communicating with Payers
What enforcement activities have we seen from FDA, DOJ or others regarding formulary communications? Are the rules different for pre-approval formulary communications versus off-label information? Do FDA policies on non-promotional scientific exchange apply to any formulary communications? This panel will explore the rules and practices that govern communicating drug information to payers and formulary committees in light of evolving FDA policies on scientific exchange, First Amendment case law, and proposed legislative changes to FDAMA 114.
DOJ – OIG Compliance Update and Recent Settlements
This session will discuss recent enforcement activities by the US Department of Justice and the US Department of Health and Human Services, Office of Inspector General, against the medical products industries. What lessons can be learned from the latest settlements and issues raised?
This panel will provide an update on recent FDA developments and legislative proposals relating to direct-to-consumer (DTC) advertising, along with the evolution of DTC advertising from an industry perspective. The issue of the current impact of DTC on the learned intermediary defense, the state of the law and trends in the decisions, and potential future developments will also be discussed.
Question & Answer Panel with FDA
FDA Center representatives will respond to questions you have submitted throughout the day. This is your opportunity to engage with FDA and learn valuable takeaways from the discussion.
Registration and Continental Breakfast
FDA Guidances: An Industry Perspective
Panelists from industry will explore issues they have faced in interpreting and implementing FDA guidances, focusing on the practical issues they deal with on a daily basis.
Commercial Speech: Key Cases and Their Practical Implications
Industry has recently had a number of significant victories in criminal and civil off-label promotion cases. In this session, panelists will share key lessons learned, implications for future off-label promotion, and offer practical tips for how pharmaceutical and medical device companies can effectively navigate off-label communications. These favorable outcomes also demonstrate that litigation, both offensive and defensive, can be a powerful tool to shape off-label policy and to protect the rights of manufacturers.
Concurrent Breakout Sessions
Trends and Special Issues for Device Promotion
Because the definition of a medical device depends on its intended use, which is established through labeling, advertising, and statements by the manufacturer, it’s critical that companies exercise care when promoting products. This session will bring you up-to-speed on current trends and special issues for device promotion.
Mobile Medical Apps
There is a graveyard of well-intentioned mobile apps littering laptops and handheld devices. Although the industry has had high hopes for branded apps, there have been many regulatory hurdles to overcome such as fair balance, disclosure, privacy, 2253 submission, and medical device designation. With careful planning, deploying a successful mobile app is possible in order to help patients understand their condition, safely use their prescriptions, speed their start on drug therapy through request forms, and collect data for benchmarking and planning purposes. A panel of diverse speakers will share their experiences and best practices.
Precision Medicine, Diagnostics, and Laboratory-Developed Tests: Special Promotional Issues
This session will address the challenging promotional issues for Precision Medicine products and services, including new drug products, unapproved combinations of drugs, approved and unapproved diagnostic tests, and laboratory developed tests. Final guidance from FDA on its regulation of LDTs is forthcoming; however, many stakeholders are uncertain of the legality of FDA’s regulation. This breakout will explore these concerns.
Concurrent Breakout Sessions
Life after a Corporate Integrity Agreement
Companies emerging from a Corporate Integrity Agreement (CIA) face many challenging issues even after spending years responding to regulatory obligations. Learn from those that have been under CIAs, how they have survived, and ways to proactively shift to a risk-mitigation model driven by company needs, current industry practices, and enforcement trends.
Making the Most of Social Media: Innovative Uses and Practical Experience
Drug and device companies continue to expand their presence using social media to connect with consumers and healthcare professionals. Get practical advice on how some of the industry’s leading companies are ensuring compliance with FDA regulatory requirements while applying draft guidance for social media use.
Promotional Review Committees: Advanced Strategies
This session will discuss the promotional issues arising from drug and device companies’ use of promotional review committees (PRCs) and how PRCs can be used effectively to mitigate risk, as well as what pitfalls exist for companies employing them.
Challenging Hypotheticals – What Would You Do?
In this interactive session, panelists will present a host of difficult, but practical hypothetical scenarios faced by companies every day.
Continuing Legal Education
FDLI applies for CLE credits in Ohio, Pennsylvania, and Virginia. These CLE approvals may also be honored by other states; please check with your bar association for guidance. The CLE credits will be posted as they are granted and you can request to be notified when approval is received.
Location and Overnight Accommodations