Conference Program
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Day 1 - Friday, February 26, 2021

9:00
Opening Remarks from the Co-Chairs

Diane McEnroe
Partner
Sidley Austin LLP

Renuka Singh
Senior Legal Counsel
RB

9:15

Focus on Monograph Reform Keynote

Part I
How to Prepare for a Modernized OTC Drug System under the CARES Act

Daniel R. Dwyer
Partner
Kleinfeld, Kaplan and Becker, LLP

Deborah Livornese
Partner
Hyman, Phelps & McNamara P.C.

Frederick A. Stearns
Partner
Keller and Heckman LLP

  • Overview of changes under the CARES Act, what’s included
    • What are the timelines for implementation?
  • How will Administrative process work?
    • Determining when to use an NDA versus an OMOR
    • Learn key criteria for petitions and when they should be filed
  • What are the FDA’s priorities and where does the agency see opportunities for growth, line extensions?
  • Assessing the impact of COVID on FDA activities
  • Examining how the juxtaposition of the current status of the Sunscreen Innovation Act and Monograph Reform under the CARES Act Status of Sunscreen Innovation Act

10:00

Focus on Monograph Reform Keynote

Part II
OTC Drug Innovation: New Ingredients, Delivery Methods, and Monographs in Limbo

Paul Rubin
Partner
Debevoise & Plimpton LLP

Renuka Singh
Senior Legal Counsel
RB

  • Reviewing the status of category II ingredients
  • Identifying evolving monographs that need more data
    • Where are the safety and efficacy data gaps for widely used products: sunscreen, antiseptics, antimicrobials?
  • Anticipating category III products and other proposed or tentative ingredients be addressed?
  • Examining how new forms delivery methods such as gels, foams, patches be treated under the monograph
  • Assessing future opportunities for combination products

10:45
Break
11:15
OTC Drug Imports: Manufacturing and Labeling Best Practices to Avoid Detentions and Rejections at the Border

William McConagha
Partner
Skadden, Arps, Slate, Meagher & Flom LLP

Claudia Lewis
Partner
Venable LLP

  • Analyzing the recent flurry of questions on product labelling, stability and testing for imports—OTC drugs and devices
  • Forecasting why the FDA may block product entry
    • Contrast laws for imports vs. manufactured in the U.S.
  • Ensuring supplier integrity and compliance when under increased scrutiny by customs
  • Complying with cGMPS when using contract manufacturers
    • Litigation risk and unique defenses
  • Vetting product labels and advertising claims for language that could prevent access to the U.S.

12:00
Labels and Safety Communications: How to Mitigate Litigation Risk and Stay Compliant amid Monograph Reform

Erin Leslie
Assistant General Counsel
Sanofi

Kathleen Sanzo
Partner
Morgan, Lewis & Bockius LLP

  • Exploring labelling format and content requirements
  • Understanding how these requirements might evolve under Monograph reform
  • Understanding the nexus between labeling and adverse event reporting
    • Analyzing label requirements relative to the reporting of adverse events
  • Assessing how use of new technologies to enhance label sets have changed the essentials of labeling requirements for OTC drug products and enhanced safety
  •  Examining how to mitigate risk with additional warnings for products transitioning from Category III to Category I
  • Evaluating label comprehension studies and remedying label failures
  • Exploring labeling challenges relative to Rx-to-OTC switches
  • Assessing the necessity of label changes
  • Understanding the scope of legitimate claims which can be made on the label
  • Recognizing labeling errors which may be associated with misbranding – potential liabilities for findings of misbranding

12:30
Lunch Break with 1:1 Networking
1:15
FDA OTC Regulatory Roundup with Live Polling

Allison Fulton
Partner
Sheppard Mullin LLP

Arianne Lindsey
Director, Regulatory Affairs
Viatris

This panel will tackle a full a slate of OTC industry challenges from the status CBD to the latest regulatory directives for homeopathic products. This is your chance to gain guidance from preeminent food and drug lawyers, industry counsel, and regulatory experts on your most vexing compliance quandaries.

  • CBD: Mitigating Operational Risk
    • Supply chain and manufacturing issues
    • State law considerations
  • Homeopathic OTC Monograph
    • Staying compliant with FDA labeling regulations
    • FTC enforcement update:
    • Implications of holding homeopathic products safety and efficacy claims to the same standard as other OTC drugs
    • How has COVID impacted the regulatory environment?
  • “No Claims” – All Natural, Allergen Free
  • cGMPs and inspections

2:00

TOWN HALL WITH FDA NAD AND INDUSTRY

Advertising and Claims Substantiation: How to Best Position your Product while Staying FTC Compliant

Kathleen Dunnigan
Senior Staff Attorney
National Advertising Division

David Grob
Director, Regulatory Affairs
Avrio Health

Raqiyyah Pippins
Partner
Arnold & Porter LLP

Christine Lee DeLorme
Division of Advertising Practices
Federal Trade Commission

  • Analyzing the latest trends and developments for claims on OTC products
    • Structure function vs. health claims
  • Gaining clarity on how to navigate promotion during the pandemic, including efficacy claims
  • Establishing an effective process for R&D, Legal, and Marketing teams to work together on claims substantiation
  • Extracting lessons from recent NAD and FTC claims substantiation activity regarding OTCs
  • Addressing problematic marketing language in relation to treating or curing COVID-19

3:00

CASE STUDY

OTC Drug Recalls: Prudent Steps to Prepare your Company for When it all Goes Sideways

Todd H. Halpern
Assistant General Counsel
GlaxoSmithKline

Ryan Gooley
Recall Consultant
Sedgwick Brand Protection Solutions

Ann Begley
Partner
Wiley Rein LLP

  • Analyzing practical, real-life examples of OTC drug recalls, e.g. ,hand sanitizer contamination, packaging and labeling concerns
    • What were the nature of these recalls?
    • What corrective actions were taken?
    • What are the lessons learned?
  • Deciphering Implications of emergency use authorizations during COVID
  • Developing an action plan for small to large scale recalls
  • Tracking products when there is a middle market of distribution e.g. hotels and airlines
  • How to handle adverse events
  • Evaluating the risks and benefits of cooperating with FDA in the course of a recall
  • Voluntary recalls versus mandatory recalls
  • What are the consequences of not instituting a recall?
    • FDA seizure and injunction power
  • Devising best practices for formulating effective recall execution strategies
  • Assessing the impact of divergent post-marketing reporting requirements for OTC drugs
  • Exploring the interaction between recalls and corrective and preventive action
  • Developing Strategies for introducing a product back to market

4:00
Break
4:15

CASE STUDY

Building an Rx to OTC Switch Strategy: Lessons from Market Hits, Misses and Predictions on Future Opportunities to Switch

Heidi Gertner
Partner
Hogan Lovells LLP

Erin Oliver
Regulatory Affairs Lead, Rx-to-OTC Switch
GSK Consumer Healthcare

  • Status of the NSURE initiative
  •  Understanding how technology could potentially expand the universe of switch candidates
    • Investigating methods to validate technology and make it accessible to consumers
    • Anticipating the FDA position
    • Strategies for commercialization
  • Weighing the pros and cons of making a switch given the exclusivity provided under monograph reform
  • Impact of recent switch activity on the market—first in class switches
  • Securing buy-in from the FDA and key legal and regulatory considerations for switches

5:15
OTC Litigation Landscape: Exploring Recent Class Actions and Prop 65 Activity

Daniel Herling
Member / Co-Chair, Product Liability Practice
Mintz

Class Actions

  • Analyzing recent class action litigation activity involving performance of products, false advertising, and mislabeling
  • Assessing ways to defeat class action litigation at the certification phase

Prop 65

  • Identifying the latest wave of plaintiff’s claims made under Prop 65
  • Understanding the safe harbor provisions under Prop 65 and whether your product is exempt
  • Devising defense strategies to respond to warning letters from bounty hunters who search for products containing ingredients in violation of Prop 65

5:45
Conference Adjourns