Day 1 - Friday, January 31, 2020

7:00
Registration and Continental Breakfast
8:15
Chair’s Opening Remarks

Moulakshi (Mou) Roychowdhury
Executive Director, Regulatory Affairs – Advertising & Labeling
Allergan

8:30
Ripped from the Headlines: Townhall on Recent Controversies in Rx Drug Advertising and Promotion

Mark Gaydos
VP & Head, NA General Med. & Established Products / US Ad-Promo
Sanofi

Dara Katcher Levy
Director
Hyman, Phelps & McNamara, P.C.

  • Analysing the evolution of direct-to-consumer advertisements of Rx Drugs
  • Examining promotional efforts surrounding the advertising and labelling requirements for controlled substances, i.e., Epidiolex
  • Understanding how the ongoing debate over the inclusion of drug pricing in television advertisements would have affected messaging
  • Determining how recently issued warning letters surrounding advertising and promotional amendment concerns

9:30
CFL Guidance Trial and Error Think Tank: Meeting the Three Factor Test

Nada Glavan
Senior Director, Commercial Regulatory Affairs, Neurology Business Unit
Eisai US

Richard Lem
Associate Director, Regulatory Affairs – Advertising and Promotion
Bayer Healthcare

This industry think tank will examine advertising and promotional practices within the context of the FDA’s CFL Guidance and three- factor test. Join us as we analyze recent interpretations of the guidance and stories of success and failure:

  • Understanding what it means to promote product information from within the label
  • Exploring the concept of “out-of-label” claims
  • Understanding how the requirements of the CFL guidance interact with the NDA process
    • Does the claim need to be in the label or simply consistent with the label?
  • Examining off- label communications in relation to the CFL Guidance and First Amendment challenges
  • Understanding what it means to promote product information from within the label
    • Discussing the impact of these challenges in the Amarian and Novartis cases

10:45
Networking Break
11:00
Strategies for Incorporating Proven Marketing Concepts into the Television Advertisement of a Rx Pharmaceutical while Meeting FDA Standards

Moulakshi (Mou) Roychowdhury
Executive Director, Regulatory Affairs – Advertising & Labeling
Allergan

Jennifer Ma
SVP, Director of Integrated Production
Area 23 (New York, NY)

12:00
Networking Luncheon
1:15
Crossfire Debate on Properly Utilizing Social Media Platforms in the Promotion of Rx Pharmaceutical Products

Marc Scheineson
Partner
Alston & Bird LLP

  • Exploring the current FDA guidance relative to social media
  • Analyzing the pharmaceutical industry’s efforts to become for social media savvy and how this dovetails with advertising and promotion practices
  • Examining Rx pharmaceutical advertising and promotional efforts in social media environments such as twitter where character restrictions are in place
    • Hashtags
  • Ensuring the role of influencers and testimonials in the promotion of Rx products meet the regulatory pathway
  • Avoiding misinformation being posted on social media from third party sources

2:15
Networking Break
2:30
Focus on Regulatory Oversight in the Era of Social Media: Examining FTC-FDA Interplay in Pharmaceutical Advertising and Promotion

Denise Sánchez Palomo
Executive Director, Commercial Regulatory Affairs
Allergan

While the FDA take the lead in regulatory oversight of Rx drug advertising and promotion, in today’s multimedia world, the FTC steps in certain circumstances.

  • Examining circumstance which warrant FTC action
  • Understanding how social media has become a game changer relative to the interplay between FDA and FTC relative to Rx drug advertising and promotion
  • Exploring how the agencies look at the to prescription products
  • Remaining consistent with the label when promoting a product on an FTC regulated platform

3:15
Working Group on Fostering Teamwork, Competency and Compliance in the Advertising and Promotional Review Process

Rose Berardi-McKenna
Counsel & Associate Director, CRA
Bristol-Myers Squibb

  • Devising strategies to incorporate successful collaboration between the legal, compliance and regulatory teams in the advertising and promotional process
  • Proactively working in partnership with the FDA’s OPDP to achieve promotional compliance
  • Designing an advertising amd promotion compliance program
  • Avoiding corporate integrity agreements
    • How does the manufacturer regain consumer trust in brand name products
  • Examining additional calls for transparency regarding the television advertisement of Rx Drugs
  • Will these efforts expand to other methods of promotion such as social media?
  • Exploring the potential for states to develop regulations calling for the disclosure of WAC pricing in advertisements

4:15
Interactive Case Study: Developing a Compliant and Successful Rx Pharmaceutical Advertising and Promotional Campaign

Mark Gaydos
VP & Head, NA General Med. & Established Products / US Ad-Promo
Sanofi

Dara Katcher Levy
Director
Hyman, Phelps & McNamara, P.C.

Richard Lem
Associate Director, Regulatory Affairs – Advertising and Promotion
Bayer Healthcare

Denise Sánchez Palomo
Executive Director, Commercial Regulatory Affairs
Allergan

Our final session will put theory into practice as our panelists work with the audience to develop an advertising and promotion plan for a fictional RX drug. The demonstration will offer a guided walkthrough from start to finish with the goal of creating a compliant advertising and promotional plan for the product of focus

5:30
Conference Concludes