Advanced Legal, Regulatory and Compliance Forum on OTC Drugs - WEB by C5Group

EARN CLE CREDITS

In-Person Conference

Advanced Legal, Regulatory and Compliance Forum on

OTC Drugs

January 23–24, 2024 New York City Bar Association, New York, NY

Conference Co-Chairs:

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

Insights from Key Industry Leaders:

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

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

Heidi Gertner Partner Hogan Lovells US LLP

Todd Halpern Assistant General Counsel Haleon

Program Highlights Include: ĉ Spotlight: Proposed ACNU Rule and Monograph Reform updates featuring FDA commentary ĉ Think tank on the reclassification of Phenylephrine ĉ PFAS concerns for OTCs ĉ Rx- to-OTC Switches Case Studies: Opill and Naloxone switches ĉ Focus sessions on the Homeopathic Monograph and MoCRA’s impact on the OTC industry ĉ Advertising Drill Down: FTC’s Health Claims and Influencer Guidances & Green Guides on OTC promotion

Amy Repolgle Director, Rx-to-OTC Switch Bayer Ludjane Carvalho Director Regulatory Affairs Colgate-Palmolive David Grob Head, Regulatory Affairs & Quality Arcadia Consumer Healthcare Jennifer Santos Attorney National Advertising Division (NAD) Supporting Sponsor

ĉ OTC Post Marketing Challenges: Addressing Adverse Events, Product Recalls, Inspection and Investigations REGISTER NOW AmericanConference.com/OTC-Drugs • 888 224 2480

Associate Sponsor

Join Us in New York this January for the One and Only Legal, Regulatory and Compliance Forum for the OTC Drugs Industry. Join us in New York City on January 23-24 for ACI’s Advanced Legal, Regulatory, and Compliance Forum on Over-the-Counter Drugs. This one-of-a-kind forum has been thoughtfully designed for in-house legal and compliance counsel, industry executives, and private practice attorneys working for the OTC drug industry. Through our comprehensive and candid panel discussions, attendees will gain invaluable insights on the latest directives and compliance standards governing the production, marketing, and distribution of OTC drugs, as well as what can be expected on the horizon. Obtain critical updates on New Monograph Reform Guidance, implications of the new 'ACNU' rule proposal, the dynamics of the latest Rx-OTC switches, innovative and compliant advertising, labeling, and brand promotion tactics, recent developments in OTC enforcement activity, current class-action litigation trends, and effective and efficient recall strategies. Take advantage of the opportunity to convene with industry leaders and stay ahead of the curve in the ever-evolving landscape governing OTC drugs. Mark your calendar for what is sure to be one of the most valuable events of the year for OTC industry practitioners. Registration is now open. We look forward to seeing you in NYC!

WHO YOU WILL MEET OTC or Non-Prescription Drug Industry ĉ In-House Counsel, including generalists and those having responsibility for regulatory; IP, Patents and Trademarks; Licensing and Business Development ĉ Officers, Directors and Executives for Regulatory Affairs; Business Development, and Rx to OTC switches Prescription Drug Industry ĉ In-House Counsel having responsibility for Rx to OTC switches, regulatory affairs, and patents ĉ Officers, Directors and Executives for Regulatory Affairs and Business Development

Law Firm Attorneys for the OTC and Prescription Drug Industry whose practices focus on: ĉ FDA and food and drug law ĉ IP, patents

Accreditation will be sought in those jurisdictions requested by the CREDITS registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

For more information on ACI’s CLE process, visit: www.AmericanConference.com/Accreditation/CLE

EARN CLE/

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

2 | LINKEDIN FDA-Regulated Consumer Products: Dietary Supplements, Cosmetics, OTC Drugs

Distinguished Faculty Ann Begley Partner Wiley Rein Dan Brum, PharmD, MBA, BCPS Chief of Project Management, Office of Nonprescription Drugs Food and Drug Administration (FDA) Ludjane Carvalho Director Regulatory Affairs Colgate-Palmolive Cathy Burgess Partner Alston & Bird LLP Kellie Combs Partner Ropes & Gray Daniel R. Dwyer Partner Kleinfeld Kaplan & Becker LLP Kyle Y. Faget Partner Foley & Lardner LLP Heidi Gertner Partner Hogan Lovells US LLP Shoshana Golden Attorney ArentFox Schiff LLP Monica C. Groat Counsel Latham & Watkins LLP

David Grob Vice President, Regulatory Affairs Pocket Naloxone Company Todd Halpern Assistant General Counsel Haleon Todd Harrison Partner Venable LLP David Horowitz Partner Hogan Lovells US LLP John F. Johnson III Senior Counsel Shook, Hardy & Bacon L.L.P

Nikki Reeves Partner King & Spalding LLP Amy Repolgle Director, Rx-to-OTC Switch Bayer Paul D. Rubin Partner Debevoise & Plimpton LLP Jennifer Santos Attorney National Advertising Division (NAD) May Smith Marketing Director, Rx to OTC Switch Haleon

Kristen Klesh Partner Loeb & Loeb LLP

Andrew Soukup Partner Covington & Burling LLP

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

Frederick A. Stearns Partner Keller & Heckman LLP

Stephen McConnell Partner Reed Smith LLP Diane McEnroe Partner Sidley Austin LLP Steve Mister President & CEO Council for Responsible Nutrition James Prochnow Partner Greenberg Traurig LLP

Simone Swafford, DRSc, MS CEO/Founder Vogue Regulatory Meghan G. Walters Price Director and Assistant General Counsel The Procter & Gamble Company Liping Wu, MD, PhD, RAC Global Regulatory Affairs Manager Kenvue

Pre-Conference Workshop MONDAY, JANUARY 22, 2024 9:00–12:30 Registration to begin at 8:30 (Break 10:30–11:00)

OTC Regulatory Boot Camp: An Essential Primer on Mastering the Regulatory Framework Governing Over-the-Counter Drug Products microphone-alt David Grob, Head, Regulatory Affairs & Quality, Arcadia Consumer Healthcare Simone Swafford, DRSc, MS, CEO/Founder, Vogue Regulatory This primer will provide attendees with an essential an in-depth working knowledge of the cornerstone laws and regulations applicable to the production, marketing and distribution of OTC drugs. Topics addressed during this workshop will set the stage for the main conference by helping you to thoroughly comprehend the complexities and challenges associated with the laws, regulation and governance of OTC drug and consumer health products in the United States. Topics to be covered will include: • Defining OTC drug products » Drugs vs. cosmetics vs. supplements » Cosmeceuticals vs. nutraceuticals • Demystifying the laws and regulations governing OTC drugs » Exploring the criteria for OTC drug products » Safety, efficacy, self-diagnosis, self-treatment • Comparing and contrasting OTC drugs vs. Rx drug products

• Determining how the OTC Drug Review process is established in the United States » Identifying which drugs are covered under the OTC Drug Review process » The monograph system • Monographs vs. NDAs • When is an NDA or ANDA used in the OTC process?

• Understanding Monograph Reform under the CARES Act • Examining the role and authority of FDA in the U.S. OTC market, including • What information does a monograph contain? analyzing the interplay between the various offices within the FDA • What if you want to deviate from the monograph and innovate? » CDER’s Office of Nonprescription Drug Products • The significance of the label » The Office of Drug Evaluation IV (ODE IV) » What information must an OTC label contain » Office of New Drugs • OTC advertising and promotion fundamentals and examining FTC’s » Nonprescription Drug Advisory Committee and NAD’s role in the space • Understanding the journey of an OTC Drug to Market » If it’s a new drug » If it’s not a new drug » Rx-to-OTC switch

4 | LINKEDIN FDA-Regulated Consumer Products: Dietary Supplements, Cosmetics, OTC Drugs

Main Conference Day One TUESDAY, JANUARY 23, 2024 7:15

10:30

Continental Networking Breakfast and Registration

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

8:15

Co-Chairs’ Welcome Remarks microphone-alt Liping Wu, MD, PhD, RAC, Global Regulatory Affairs Manager, Kenvue Heidi Gertner, Partner, Hogan Lovells US LLP

microphone-alt Ludjane Carvalho, Director Regulatory Affairs, Colgate-Palmolive John F. Johnson III, Senior Counsel, Shook, Hardy & Bacon L.L.P Heidi Gertner, Partner, Hogan Lovells US LLP

8:30 FDA INSIGHTS

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

The OTC industry has undergone a transformation in recent years due to Monograph Reform mandated by the CARES Act. The FDA has also recently issued new guidance in this matter. This panel will analyze the industry’s response to the new framework as well as implementation considerations and challenges. Topics of discussion include:

THE FUTURE OF ACNU

• Examining FDA’s recently released guidance impacting the preparation and submission of OMORs

9:00

Decoding FDA's Proposed ACNU Rule and Unveiling Its Implications for the OTC Industry microphone-alt Paul D. Rubin, Partner, Debevoise & Plimpton LLP Bethany J. Hills, Vice Chair FDA Regulatory Practice, DLA Piper LLP (US) FDA’s recently proposed ACNU rule aims to increase consumer access to effective nonprescription drugs by allowing Rx-to-OTC switches using tech-enabled approaches that go beyond the product label. However, the rule has been received with controversy. There are 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 10:00

Morning Networking Coffee Break

• 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 11:30

Re-classifying Phenylephrine: Navigating Recent Efficacy Concerns and the FDA's Decision-Making microphone-alt Monica C. Groat, Counsel, Latham & Watkins LLP Amidst recent revelations regarding the efficacy of the prevalent decongestant, phenylephrine, industry stakeholders are closely monitoring the FDA's deliberations regarding the potential reclassification of the drug, and its removal from the market in tablet form. 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?

12:00

Networking Luncheon

ADVERTISING, LABELING & CLAIMS SUBSTANTIATION 1:00

New Guidance Alerts: Balancing Advertising and Brand Promotion of Your OTC Drug Product With the Latest Guidance from FTC and NAD

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

microphone-alt Kellie Combs, Partner, Ropes & Gray

» Expert, celebrity, and influencer endorsements » Reviews on third-party websites

Jennifer Santos, Attorney, National Advertising Division (NAD)

» Repurposed reviews

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 2:00

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 microphone-alt Steve Mister, President & CEO, Council for Responsible Nutrition

» Disclosures of material connections to the brand or seller of the advertised product 3:15

Networking Break and Speaker Lounge

3:30

Navigating New and Evolving State Legislation Governing Chemical Contaminants in OTC Products microphone-alt 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 4:15

Exploring the Intersection of MoCRA with the OTC Drugs Industry microphone-alt Ann Begley, Partner, Wiley Rein 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

2:30

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

• Exploring the new manufacturing practices required under MoCRA and how the OTC industry can prepare for potential similar requirements

microphone-alt Meghan G. Walters Price, Director and Assistant General Counsel, The Procter & Gamble Company

• Sunscreen Monograph Update: Delving into the core components of the sunscreen monograph

• Assessing the context in which cosmetics can be classified as Over-the Counter drugs and vice versa

» Understanding its key elements, requirements, and implications for manufacturers, regulators, and consumers

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.

• 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 5:00

Closing Remarks and Recap of Day One

6 | LINKEDIN FDA-Regulated Consumer Products: Dietary Supplements, Cosmetics, OTC Drugs

Main Conference Day Two WEDNESDAY, JANUARY 24, 2024 10:15

7:30

Continental Networking Breakfast and Registration 8:15

Co-Chairs’ Opening Remarks and Recap of Day One microphone-alt Liping Wu, MD, PhD, RAC, Global Regulatory Affairs Manager, Kenvue Heidi Gertner, Partner, Hogan Lovells US LLP 8:30

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

Morning Networking Break

Navigating OTC Post-Market Challenges This two-part series will address best practices for ensuring compliance with post-market product safety requirements, including vigilance in monitoring and reporting adverse events, updating cGMP protocols in your compliance program, managing recalls and responding to FDA inspection and enforcement activity. 10:45

Navigating Adverse Events, Product Recalls and GMPs protocols microphone-alt Todd Halpern, Assistant General Counsel, Haleon Diane McEnroe, Partner, Sidley Austin LLP

microphone-alt Andrew Soukup, Partner, Covington & Burling LLP

• Analyzing best practices for handling product recalls and adverse events

Stephen McConnell, Partner, Reed Smith LLP

• Lessons learned from recent OTC drug recalls

• 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

» 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 11:30

Responding to the Latest FDA Inspection and Enforcement Activity microphone-alt Frederick A. Stearns, Partner, Keller & Heckman LLP

Focus on Rx-OTC Switches 9:15

Case Studies on Opill and Naloxone: Key Takeaways from the Latest Switch Approvals and What They Mean for Future Industry Opportunities microphone-alt Amy Repolgie, Director, Rx-to-OTC Switch, Bayer Deborah Livornese, Director, Hyman, Phelps & McNamara, P.C. Kyle Y. Faget, Partner, Foley & Lardner LLP 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

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

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12:15

Traversing the Unique Legal Landscape Governing Homeopathic Products microphone-alt Todd Harrison, Partner, Venable LLP Liping Wu, MD, PhD, RAC, Global Regulatory Affairs Manager, Kenvue James Prochnow, Partner, Greenberg Traurig LLP 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

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• Gaining insights into the reclassification of homeopathic products as unapproved drugs and the resulting impact on the industry

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

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8 | LINKEDIN FDA-Regulated Consumer Products: Dietary Supplements, Cosmetics, OTC Drugs

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