Continental Networking Breakfast and Registration

Co-Chairs’ Welcome Remarks

Liping Wu
MD, PhD, RAC, Global Regulatory Affairs Manager
Kenvue

Heidi Gertner
Partner
Hogan Lovells LLP

FDA INSIGHTS

Keynote Address

Dan Brum
PharmD, MBA, BCPS, Chief of Project Management, Office of Nonprescription Drugs
Food and Drug Administration (FDA)

THE FUTURE OF ACNU

Decoding FDA’s Proposed ACNU Rule and Unveiling Its Implications for the OTC Industry

Paul D. Rubin
Partner
Debevoise & Plimpton LLP

Jae Kim
Attorney
DLA Piper LLP (US)

FDA’s recently proposed ACNU rule aims to increase consumer access to effective nonprescription drugs by allowing Rx-OTC switches using tech-enabled approaches that go beyond the product label.  However, the rule has been received with controversy as it creates complex questions regarding safety, technology, IP and exclusivity, and is also likely to decrease economic opportunities for switch products.  This panel will unwrap the proposed ACNU rule with topics of discussion including:

• Understanding how this new proposed rule fits into the current regulatory landscape governing OTC drugs
  • Examining what kind of OTC approval system this will create for Rx-OTC switches
• How are consumers vs industry perceiving the rule from an ease of implementation standpoint?
  • What will the criteria be to establish additional conditions of use/safety?
  • Analyzing the potential introduction of a digital platform that consumers can use to establish if the product is right for them
  • Will AI play a role in the software potentially being used?
• Exploring the potential hurdles in ACNU’s implementation journey
• What specific complications may arise when a switch product becomes a generic?
• Contemplating the impact of the proposed rule on financial incentives and opportunities for OTC companies
• Analyzing industry’s comments on the rule and how these could impact the final piece of legislation

Morning Networking Coffee Break

Mastering the Monograph Reform: Addressing Implementation Phase Challenges and Navigating Recent New FDA Guidances

Ludjane Carvalho
Director Regulatory Affairs
Colgate-Palmolive

Heidi Gertner
Partner
Hogan Lovells LLP

John F. Johnson III
Senior Counsel
Shook, Hardy & Bacon L.L.P

The OTC industry has undergone substantial transformations in recent years following the Monograph Reform mandated by the CARES Act. With new guidance recently coming out from the FDA, this panel will analyze the industry’s response to the new framework as well as implementation considerations and challenges.  Topics of discussion include:

• Examining FDA’s recently released guidance impacting the preparation and submission of OMORs
• Updates on the latest implementation activity, timelines and status of FDA meetings with industry
• Evaluating the advantages of opting for an OMOR vs. NDA submission and exploring market exclusivity strategies for each approach
• Assessing the industry’s response to the monograph reform
  • Have the new ingredient submission fees influenced innovation within the OTC space?
• OMUFA Part 2: Forecasting potential changes to the Reauthorized OTC Monograph Drug User Fee Program
  • Examining what progress is being made in negotiations with Congress for the reauthorization of the OMUFA: what has been happening behind the scenes, what does the negotiation process currently look like and where do things currently stand?
  • Understanding the role of FDA and industry stakeholders in this process, and forecasting what changes may occur with the law

SPOTLIGHT ON PHENYLEPHRINE

Re-Classifying Phenylephrine: Examining Recent Efficacy Concerns and Implications of the FDA’s Decision-Making

Monica C. Groat
Counsel
Latham & Watkins LLP

Amidst recent revelations regarding the declining efficacy of this prevalent decongestant, industry stakeholders are closely monitoring the FDA’s deliberations regarding the potential reclassification and withdrawal of phenylephrine in tablet form, from the market.

In this session, we will delve into the far-reaching implications these decisions may hold for the broader over-the-counter (OTC) market.

• Examining committee decisions and their potential influence on regulatory status changes
• Can the industry expect FDA to issue a proposed order removing it from the GRASE category?

Networking Luncheon

ADVERTISING LABELING & CLAIMS SUBSTANTIATION

Balancing Advertising and Brand Promotion of Your OTC Drug Product with the Latest FTC Guidance on Health Claims and Green Claims

Kellie Combs
Partner
Ropes & Gray

Jennifer Santos
Attorney
National Advertising Division (NAD)

Nikki Reeves
Partner
King & Spalding LLP

• Grappling with the implications of the FTC’s new Health Products Claim Substantiation Guidance on OTC drug products
  • How much evidence, and what type of evidence, will be needed going forward to substantiate health-related claims for OTC drugs?
  • Developing effective advertising, labeling and substantiation strategies while steering clear of compliance pitfalls
• Examining the proposed changes to the Green Guides and the impact that FTC’s contemplated rulemaking could have on environmental marketing claims for OTC drug products (eco-friendly, biodegradable, etc.)
  • Exploring differences in FTC’s guidance and state law requirements for the term “recyclable”
• Understanding the nuances between superiority and comparative efficacy claims
  • Analyzing the clinical data requirements needed to support these claims
  • How are FTC and NAD viewing/treating these claims?
• Developing a roadmap for testing and claims substantiation that will protect your OTC drug product from FTC and NAD scrutiny, as well as attacks from the plaintiff’s bar
• Special considerations for making and substantiating ESG claims

Understanding How the FTC’s Health Product Guidance is Different for OTCs vs. Supplements: Lessons that the OTC Industry Can Take from the Supplements Industry

Steve Mister
President & CEO
Council for Responsible Nutrition

Social Media Claim Essentials: Making Effective and Compliant OTC Drug Claims on Social Media in a Time of Evolving Agency Directives

Meghan G. Walters Price
Director and Assistant General Counsel
The Procter & Gamble Company

Kristen Klesh
Partner
Loeb & Loeb LLP

When dealing with non-traditional advertising tactics such as influencer marketing, online celebrity endorsements, bloggers or consumer reviews, OTC drug companies must be diligent in ensuring that claims about their products are thoroughly substantiated, appropriate disclosures are made, and
compliance teams are aware of the latest regulatory guidance and concerns. This panel will explore topics including:

• Determining how to compliantly promote your product and win consumer confidence while staying out of trouble with the regulators
• Examining how new FTC substantiation guidance, endorsement disclosure guidelines, and enforcement activity around use of consumer reviews are impacting social media and other online marketing by OTC drug companies
• Developing best practices for:
  • Consumer endorsements and consumer reviews
  • Expert, celebrity, and influencer endorsements
  • Reviews on third-party websites
  • Repurposed reviews
  • Disclosures of material connections to the brand or seller of the advertised product

Networking Break and Speaker Lounge

Navigating New and Evolving State Legislation Governing Chemical Contaminants in OTC Products

Daniel R. Dwyer
Partner
Kleinfeld Kaplan & Becker LLP

• Analyzing state packaging and sustainability laws, such as California’s SB 54, and their impact on the OTC drug industry
• Grappling with evolving state law packaging and sustainability trends, such as extended producer responsibility laws and varying PFAS packaging bans
• Examining the compliance implications of additional state chemical contaminant legislation coming down the pike
• Taking a look at new state legislation banning titanium dioxide in foods: forecasting the consequences for industry if similar bans are extended to OTC drug products

Exploring the Intersection of MoCRA and the OTC Drugs Industry

Ann Begley
Partner
Wiley Rein LLP

Shoshana Golden
Attorney
ArentFox Schiff LLP

With numerous companies operating in both the cosmetics and OTC drug spheres, the interplay between the regulation of both products presents fascinating dynamics. This panel discussion will examine the intricate relationship between cosmetics, OTC drugs, and the regulatory landscape that binds them.

• Examining the similarities between MoCRA and the CARES Act of 2020 with respect to cosmetics and OTC drugs
• Exploring the new manufacturing practices required under MoCRA and how the OTC industry can prepare for potential similar requirements
• Assessing the context in which cosmetics can be classified as Over-the Counter drugs and vice versa
• Sunscreen Monograph Update: Delving into the core components of the sunscreen monograph
• Understanding its key elements, requirements, and implications for manufacturers, regulators, and consumers
• Identifying what proactive actions the industry can take to prevent benzene contamination in sunscreen
• Analyzing FDA’s proposed regulations for testing and labeling requirements for sunscreen products

Closing Remarks and Recap of Day One

Continental Networking Breakfast and Registration

Co-Chairs’ Opening Remarks and Recap of Day One

Liping Wu
MD, PhD, RAC, Global Regulatory Affairs Manager
Kenvue

Heidi Gertner
Partner
Hogan Lovells LLP

Class Action Activity Roundup: Addressing The Latest and Greatest in Plaintiffs’ Bar Attacks on OTC Drug Products

Andrew Soukup
Partner
Covington & Burling LLP

Stephen McConnell
Partner
Reed Smith LLP

• Assessing the latest emerging OTC product liability and false advertising litigations and class action activity
• Addressing the rising trend of consumer advocacy research labs (e.g. Valisure, Emery Pharma) performing their own testing on OTC products that are spawning product recalls and class litigations
  • Understanding the role of these consumer advocacy groups and their behind-the-scenes coordination with the plaintiffs’ bar
• Navigating the unique challenges inherent to OTC product litigations, such as lack of prescriptions, receipts and written records of product use
• Safeguarding your company and brand against the risk of false advertising /deception class actions

Focus on Rx-OTC Switches

Case Studies on Opill and Naloxone: Key Takeaways from the Latest Switch Approvals and What They Mean for Future Industry Opportunities

Kyle Y. Faget
Partner
Foley & Lardner LLP

Amy Replogle
Director, Rx-to-OTC Switch
Bayer

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

FDA’s recent efforts to enhance accessibility to OTC drug products have set the stage for a wave of approved switches in the industry – a development being warmly embraced by non-prescription drug companies. This panel will:

• Analyzing the high-profile switches shaping the OTC industry landscape
  • Opill
  • Naloxone
• Explore what FDA has considered in approving the latest switches and hurdles industry may face in obtaining future switches
• Assessing the significance of the Opill switch and its implications on new opportunities for RX-OTC switches, particularly in the area of women’s health

Morning Networking Break

Navigating OTC Post-Market Challenges

Navigating Adverse Events, Product Recalls and GMPs Protocols

Todd Halpern
Assistant General Counsel
Haleon

Diane McEnroe
Partner
Sidley Austin LLP

• Analyzing best practices for handling product recalls and adverse events
• Lessons learned from recent OTC drug recalls
  • Updating cGMP protocols in your compliance program based on the latest FDA/industry recall activity
• Addressing the rise in product and packaging contaminants being identified by third-party labs: when should you initiate a recall and when should you not?
• Assessing how GMPs should be modified in response to FDA’s recent guidance on nitrosamines

Navigating OTC Post-Market Challenges

Responding to the Latest FDA Inspection and Enforcement Activity

Frederick A. Stearns
Partner
Keller and Heckman LLP

Cathy Burgess
Partner
Alston & Bird LLP

David Horowitz
Partner
Hogan Lovells US LLP

• Investigating recent trends in OTC drug manufacturing inspections
  • Anticipating and preparing for both unannounced and routine inspections by FDA
  • Preparing for a paper inspection vs. an in-person inspection from FDA
  • Examining how new FDA inspection tools and remote regulatory assessments may help to increase inspection efficiencies
• Shedding light on the latest areas of focus for FDA enforcement
• Examining the latest wave of FDA warning letters issued to OTC drug manufacturers regarding GMP issues – what trends are we seeing and what are the implications?
• Examining the role of compliance and ingredient transparency in shaping OTC products’ market presence

Traversing the Unique Legal Landscape Governing Homeopathic Products

Todd Harrison
Partner
Venable LLP

James Prochnow
Partner
Greenberg Traurig LLP

Liping Wu
MD, PhD, RAC, Global Regulatory Affairs Manager
Kenvue

This panel session will examine the implications of FDA’s December 2022 guidance for homeopathic products and the ongoing efforts and strategies employed by both the industry and FDA to ensure compliance and navigate the evolving regulatory landscape within this niche segment.

• Developing a comprehensive understanding of the nuanced regulatory environment in which homeopathic products operate
• Addressing notable actions taken by regulatory bodies in response to safety concerns, particularly highlighting FDA’s actions against injectable homeopathic drugs
• Gaining insights into the reclassification of homeopathic products as unapproved drugs and the resulting impact on the industry

Co-Chairs Closing Remarks and Recap of Day Two Conference Concludes