Published on Drug and Device Law
on December 15, 2015
We learned about it yesterday from a reporter, but were sworn to secrecy until today. Pacira Pharmaceuticals and the FDA settled their litigation with Pacira getting essentially everything it wanted – what the company calls
“favorable resolution.” Pursuant to the settlement agreement
, the FDA is formally rescinding
its unfortunate warning letter that attempted a retroactive reduction in the scope of the indications of Exparel’s (the drug at issue) approval. [Read More
The legal and regulatory space for promotion of drugs and devices has continued to evolve at a rapid pace over the last few months. As drug and device manufacturers pursue ever more innovative and creative strategies to spread awareness of their products, they must ensure that they remain compliant of FDA guidelines. With so many potential areas for legal and regulatory pitfalls, it is important to obtain a big picture overview of the challenges associated with promoting a drug or a device. This unique and interactive forum will help you understand the entire legal, regulatory, and political background affecting the promotion and advertising of drugs and devices.
Learn About Recent Developments That Will Impact Your Next Promotion
The industry anxiously awaits how the recent decision in Amarin Pharma Inc. v. FDA
will affect off-label marketing and exactly what type of communication is permitted under the ruling. American Conference Institute’s Promotional Review Compliance for Drug and Devices
will help you comprehend the limits and boundaries of the Amarin case on off-label marketing. While the industry examines the impact of the case outside of the Second Circuit, it is clear for now that Amarin will impact drug and devices companies beyond their marketing efforts in areas such as the approval process and government enforcement. In addition to a thorough discussion on off-label marketing, this conference brings you cutting edge and up-to-date information from the nation’s most prestigious pharmaceutical and medical device manufacturers so that you can benchmark your practices against those of leading companies.
Hear From Key Government Enforcers and Regulators
Attend this event and learn to position yourself so that you can preemptively fend off promotional challenges and respond successfully to government queries about your promotional activities. An esteemed faculty comprised of top in-house counsel, leading law firms, and regulatory affairs experts will help you understand and analyze recent litigation trends, enabling you to create compliant promotional materials and insulate your company from such activity. In addition, you will have the opportunity to hear from state and federal regulators at the forefront of advertising and promotion enforcement.
Maintain Control Over Promotions on Social Media
Given the constant and increased communication between patients, doctors, companies, bloggers, and patient advocates on social media, drug and device manufacturers must develop a comprehensive strategy on how to maximize the benefit of Internet and social media platforms. ACI’s forum will help you examine what your options are when responding to misinformation about your product on social media, and ensure a fair balance when communicating the risks and benefits.
ACI’s post-conference workshop will give you the knowledge needed to develop compliant promotions while minimizing the legal and regulatory risks. In this comprehensive workshop—Interactive Mock PRC: Managing a Promotional Review Meeting from Start to Finish Through Specific Case Studies and Examples
—you will learn how to end up with a promotion that satisfies each business, legal, and regulatory requirement.
Register now to save your spot at this timely conference by calling 888-224-2480
or by going online