FDA marketing scrutiny no longer is limited to magazine and TV ads. Now the agency is poking around, checking signage in tradeshow booths ... checking in on Twitter, YouTube and Facebook ... and listening to the physicians and other healthcare professionals you've paid to speak or train.
In 2016 the Office of Prescription Drug Promotion issued 11 enforcement letters. A 20 percent increase from 2015. Six of those 2016 letters were issued in December alone. What is the meaning of OPDP’s recent upswing in enforcement?
Face it: You need help. Not with creating better ads and promotions — you already know how to do that — but for making sure your promotional activities aren't magnets for warning letters.
Come to Arlington in April for two days of intense learning. You'll arrive back home with a bag full of tricks and tips to keep all your marketing efforts squeaky-clean.
- Understanding Pre-Approval Communications: Don't get on the FDA's or SEC's radar screens before your product is even approved. Learn how to properly disclose information and remain in compliance.
- How to Maximize Disease Awareness Communications: Take away valuable tips and tricks for using disease awareness communications pre- and post-approval.
- Hurray! You're Approved: Build the most aggressive — but compliant — campaign from first day of approval to commercial launch.
- Assuring Your Promotions Meet FDA Off-Label Standards: Successfully navigate 4 major traps that can earn you a warning letter fast.
- Itching to do More with Social Media?: Discover how to get your message out there ... without crossing the line.
- Understanding Off-Label Communications: How will the November 2016 FDA memo and January 2017 FDA guidance affect your communications?
Need resources to stay on top of future developments? The workshop binder materials alone are worth the tuition cost. Checklists for promotion pre-approval and effective review, FDA documents, complete and unabridged ... relevant sections of Form 2253 [CFR] ... PhRMA's Principles on DTC Advertising and Principles on Interactions with Healthcare Professionals ... ... and much more!
Your workshop leader is Dale Cooke, principal of PhillyCooke Consulting. Mr. Cooke's practice specializes in helping FDA-regulated companies develop compliant promotional tactics and improve the promotional review. He is the author of Effective Review & Approval of Digital Promotional Tactics and is currently at work on a book about compliant social media usage for prescription product manufacturers.
And here's a bright idea: Pass this on to your ad agency or marketing consultant. Better yet, bring them along for a crash course in the stuff they need to know too!
Whatever your line of endeavor — drugs, biologics, devices — if you advertise, the FDA has its eye on you. Why risk a Form 483 or a warning letter when compliance help is so close at hand?
Course Binder Materials:
- Full slides from the PowerPoint presentations
- Reference documents:
- FDA Advertising & Procedural Guidances
- Help-Seeking Guidance
- DTC Broadcast Guidance & Q&A
- FDAAA Pre-Dissemination Review Requirements
- Product Name Guidance (All three versions from 1999, 2012, and 2013)
- Presenting Risk Information Guidance
- Social Media Guidances
- Postmarketing Submissions Requirements
- Responding to Unsolicited Requests for Off-label Information Presenting Risk Information in Space-limited Contexts Correcting Third-party Misinformation
- Distributing Off-Label Reprints
- Relevant Sections of Code of Federal Regulations Form 2253
- PhRMA Principles on DTC Advertising
- PhRMA Principles on Interactions with Healthcare Professionals
- Pre-approval Promotion Checklist
- Effective Review & Approval Process Checklist Keys to Evaluating Promotional Review Systems List of Key Resources for Continuing Education
- Articles by Dale Cooke
- Developing Compliant Search Engine Marketing Campaigns (Publication Date of September
- Industry Standards for Linking Disease Awareness Websites to Product Promotion
- Patient Testimonial Videos: FDA Actions on Risk Information Presentation
- Presenting Risk Information on Websites
- Where Things Stand on FDA Guidance on Social Media (Publication Date of September 2014)