Advanced Legal, Regulatory, and Compliance Forum on Over The Counter Drugs

EARN CLE CREDITS

Advanced Legal, Regulatory, and Compliance Forum on

Over The Counter Drugs February 26, 2021 (Eastern Standard Time) | Virtual Conference

Distinguished Co-Chairs: Diane McEnroe Partner Sidley Austin LLP

Gain Practical Industry Insights from: Renuka Singh Senior Legal Counsel RB

Spotlight on Monograph Reform Develop a Practical Roadmap to Set Your Organization up for Success: How to Prepare for a Modernized OTC Drug System

David Grob Director, Regulatory Affairs Avrio Health

Todd Halpern Assistant General Counsel GlaxoSmithKline

Erin Leslie Assistant General Counsel Sanofi

Hear from leading OTC industry counsel and regulatory executives who will provide timely analysis and best practices for: ĉ Preparing for monograph reform under the CARES Act

under the CARES Act

ĉ Substantiating COVID-related claims

Identify Opportunities for Future Growth:

ĉ Identifying labeling and manufacturing missteps for imports, to avoid costly hold ups at the border

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

ĉ Leveraging lessons from recent Rx-to-OTC switch success stories to overcome complex legal and regulatory hurdles ĉ Navigating recalls and adverse events protocols

In-Depth Content Enhanced by Interactive Virtual Features:

1:1 Networking with Delegates and Speakers

AmericanConference.com/OTCDrugs • 888 224 2480

Hall with FTC, NAD, and Industry: Advertising and Claims Substantiation: How to Best Position UNIVERSITY Town your Product while Staying FTC Compliant



Live Polling: FDA OTC Regulatory Roundup: CBD, Homeopathic Monograph, "No-Claims", and cGMPs

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Leading OTC industry stakeholders will gather at American Conference Institute’s Advanced Legal, Regulatory, and Compliance Forum on Over the Counter Drugs to discuss significant changes to the Monograph system on February 26, 2021.

This is the only advanced legal and regulatory symposium specifically designed to provide practical insights on enforcement activity and preventative measures for the non-prescription drug industry.

The Forum will put a spotlight on Monograph reform under the CARES Act. This long-anticipated modernization effort intends to create a system that is more responsive to safety and efficacy while also encouraging innovation.

Attend this event and decipher what monograph reform means for the industry.

Walk away with a sense of clarity on how to adhere to a new regulatory regime and best practices for managing other prominent shifts in the OTC drug landscape sparked by the response to the pandemic.

OTC or Non-Prescription Drug Industry M Officers, Directors and Executives for Regulatory Affairs; Business Development, and Rx to OTC switches

Prescription Drug Industry M In-House Counsel having responsibility for Rx to OTC switches, regulatory affairs, and patents

CO-CHAIRS Diane McEnroe Partner Sidley Austin LLP

M Officers, Directors and Executives for Regulatory Affairs and Business Development

Ann Begley Partner Wiley Rein LLP

Erin Leslie Assistant General Counsel Sanofi

Christine Lee DeLorme Division of Advertising Practices Federal Trade Commission

Claudia Lewis Partner Venable LLP

Kathleen Dunnigan Senior Staff Attorney National Advertising Division Dan Dwyer Partner Kleinfeld Kaplan Becker LLP Allison Fulton Partner Sheppard Mullin Heidi Gertner Partner Hogan Lovells LLP

2 | #OTCDrugs

M IP, patents

twitter: @ACI_Pharma linkedin: ACI: OTC Drugs & Dietary Supplements

Arianne Lindsey Director, Regulatory Affairs Viatris Deborah Livornese Partner Hyman, Phelps & McNamara P.C. William McConagha Partner Skadden, Arps, Slate, Meagher & Flom LLP Erin Oliver Regulatory Affairs Lead, Rx-to-OTC Switch GSK Consumer Healthcare Raqiyyah Pippins Partner Arnold & Porter LLP

David Grob Director, Regulatory Affairs Avrio Health

Paul Rubin Partner Debevoise & Plimpton LLP

Todd Halpern Assistant General Counsel GlaxoSmithKline

Kathleen Sanzo Partner Morgan, Lewis & Bockius LLP

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

Law Firm Attorneys for the OTC and Prescription Drug Industry whose practices focus on: M FDA and food and drug law

Renuka Singh Senior Legal Counsel RB

SPEAKERS

Ryan Gooley Recall Consultant Sedgwick Brand Protection Solutions

Who You Will Meet M In-House Counsel, including generalists and those having responsibility for regulatory; IP, Patents and Trademarks; Licensing and Business Development

Distinguished Faculty

Media Partner:

Frederick A. Stearns Partner Keller and Heckman LLP

Agenda | February 26, 2021 (Eastern Standard Time) 9:00

Opening Remarks from the Co-Chairs

• Examining how new forms delivery methods such as gels, foams, patches be treated under the monograph

MICROPHONE Diane McEnroe, Partner, Sidley Austin LLP

• Assessing future opportunities for combination products

Renuka Singh, Senior Legal Counsel, RB

Focus on Monograph Reform 9:15

PART I

How to Prepare for a Modernized OTC Drug System under the CARES Act MICROPHONE Dan Dwyer, Partner, Kleinfeld Kaplan Becker LLP

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

Frederick A. Stearns, Partner, Keller and Heckman LLP

• Exploring labeling challenges relative to Rx-to-OTC switches

11:15

• Assessing the necessity of label changes

OTC Drug Imports: Manufacturing and Labeling Best Practices to Avoid Detentions and Rejections at the Border

• Understanding the scope of legitimate claims which can be made on the label

MICROPHONE William McConagha, Partner, Skadden, Arps, Slate, Meagher

• Analyzing the recent flurry of questions on product labeling, stability and testing for imports—OTC drugs and devices

• Ensuring supplier integrity and compliance when under increased scrutiny by customs

10:00 PART II

OTC Drug Innovation: New Ingredients, Delivery Methods, and Monographs in Limbo MICROPHONE 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 how category III products and other proposed or tentative ingredients be addressed

• 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 MICROPHONE Erin Leslie, Assistant General Counsel, Sanofi

Kathleen Sanzo, Partner, Morgan, Lewis & Bockius LLP

• Exploring labeling format and content requirements • Forecasting 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 • Examining how to mitigate risk with additional warnings for products transitioning from Category III to Category I

AmericanConference.com/OTCDrugs • 888 224 2480

12:30

Claudia Lewis, Partner, Venable LLP

• How will the administrative process work? » Determining when to use an NDA versus an OMOR » Learn key criteria for petitions and when they should be filed

• Examining the juxtaposition of the current status of the Sunscreen Innovation Act and the Monograph Reform under the CARES Act Status of Sunscreen Innovation Act

• Recognizing labeling errors which may be associated with misbranding – potential liabilities for findings of misbranding

& Flom LLP

• Understanding why the FDA may block product entry » Contrast laws for imports vs. manufactured in the U.S.

• Assessing the impact of COVID-19 on FDA activities

• Evaluating label comprehension studies and remedying label failures

10:45 Break

• Overview of changes under the CARES Act, what’s included » What are the timelines for implementation?

• What are the FDA’s priorities and where does the agency see opportunities for growth, line extensions?

• Assessing how use of new technologies to enhance label sets have changed the essentials of labeling requirements for OTC drug products and enhanced safety

Lunch Break with 1:1 Networking 1:15

FDA OTC Regulatory Roundup with

 Live Polling

MICROPHONE Allison Fulton, Partner, Sheppard Mullin

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

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

2:00 TOWN HALL WITH FDA, NAD, AND INDUSTRY

UNIVERSITY

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

MICROPHONE Kathleen Dunnigan, Senior Staff Attorney,

• Deciphering Implications of emergency use authorizations during COVID-19

• Weighing the pros and cons of making a switch given the exclusivity provided under monograph reform

• Developing an action plan for small to large scale recalls

• Impact of recent switch activity on the market — first in class switches

• Tracking products when there is a middle market of distribution e.g. hotels and airlines

National Advertising Division

• How to handle adverse events

• Securing buy-in from the FDA and key legal and regulatory considerations for switches

David Grob, Director, Regulatory Affairs, Avrio Health

5:15

Raqiyyah Pippins, Partner, Arnold & Porter LLP

• Evaluating the risks and benefits of cooperating with FDA in the course of a recall

Christine Lee DeLorme, Division of Advertising Practices, Federal Trade Commission

• What are the consequences of not instituting a recall? » FDA seizure and injunction power

• Analyzing the latest trends and developments for claims on OTC products » Structure function vs. health claims

• Devising best practices for formulating effective recall execution strategies

• 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

• Voluntary recalls versus mandatory recalls

• 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

• Addressing problematic marketing language in relation to treating or curing COVID-19

4:15 CASE STUDY

OTC Drug Recalls: Prudent Steps to Prepare Your Company for When it all Goes Sideways MICROPHONE Todd 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?

4 | #OTCDrugs

MICROPHONE 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

• Extracting lessons from recent NAD and FTC claims substantiation activity regarding OTCs

3:00 CASE STUDY

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

Break

Building an Rx to OTC Switch Strategy: Lessons from Market Hits, Misses and Predictions on Future Opportunities to Switch MICROPHONE Heidi Gertner, Partner, Hogan Lovells LLP

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

• 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

• 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

twitter: @ACI_Pharma linkedin: ACI: OTC Drugs & Dietary Supplements

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