Consumer Healthcare 101

7:30 am-3:00 pm

Registration

7:30-8:00 am

Networking Breakfast

8:00-8:15 am

Welcome Remarks

Beth Allgaier, SVP of Business Development, CHPA

8:15-9:15 am

The State of The Industry: Commercial Update 2025

Circana will outline the sales size, key brands, manufacturers & marketers, retailers, consumer behavior and key trends for the industry in 2025. OTCs, medical devices, as well as supplements will be covered.

Speaker

Dave Hyland, VP, CPG Analytics and Business Development, Circana

9:15-10:15 am

FDA Oversight of Nonprescription Drug Products  - Part I

A discussion of FDA as the industry’s leading regulator will include an overview
of FDA’s structure and the regulatory framework for OTC drug products.

Speaker

Doug Bierer, President, Douglas Bierer Consulting, LLC

10:15-10:30 am

Break

10:30-11:30 am

FDA Oversight of Nonprescription Drug Products  - Part II

A discussion of FDA as the industry’s leading regulator will include an overview
of FDA’s structure and the regulatory framework for OTC drug products.

Speaker

Doug Bierer, President, Douglas Bierer Consulting, LLC

11:30 am-12:15 pm

OMUFA and the Future of OTC Monograph Reform

On March 27, 2020, the CARES Act reformed and modernized the regulation of OTC monograph drugs and authorized FDA to assess and collect user fees. Session attendees will learn why reform was necessary, the key elements of policy reform covered by the legislation and FDA goals letter, how user fees will be assessed and used to fund reform activities at FDA and hear updates on recent OMUFA reauthorization activities, including FDA public meetings and negotiations with industry.

Speakers

Caitlin Ondracek, Ph.D., Senior Director, Regulatory & Scientific Affairs, CHPA
Jay Sirois, Ph.D., Vice President, Regulatory & Scientific Affairs, CHPA

12:15-1:00 pm

Networking Lunch

1:00-2:00 pm

OTC Drug Labeling Regulations

The presentation will cover OTC Drug labeling requirements per 21 CFR 201.66. The importance of drug monographs will also be covered as well as some things that may change under the new OTC Drug Safety, Innovation & Reform Act.

Speaker

Daniel (Dan) Keravich, Principal, Chesapeake OTC Regulatory Strategies, LLC

2:00-3:15 pm

RX- TO- OTC Switch

An introduction to the commercial, scientific, and regulatory considerations and challenges when converting a prescription drug to a consumer product for self- care.

Speakers

Edwin (Ed) Hemwall, Principal, Edwin Hemwall LLC
Marcia D. Howard, Ph.D., CAE, Vice President, Regulatory & Scientific Affairs, CHPA 

3:30-4:15 pm

CHPA at Work to Advance Selfcare

This session is a chance for attendees to hear about key projects that are ongoing under CHPA committee umbrellas and through the work of the Foundation.  Hear from staff leads who work to promote selfcare as a critical component of public health via CHPA’s Health in Hand Foundation and the Public Affairs Committee.  Attendees will also learn about insights on the regulatory, legislative, and legal fronts with the recent change in administration.

Speakers

Brandon Ciampaglia, Director, Health in Hand Foundation 
Mike Tringale, SVP Communications, CHPA
Carolyn Herrmann, Deputy General Counsel, CHPA

4:15-5:15 pm

Networking Reception – Welcome remarks by Scott Melville 

8:00 - 12:00 pm

Registration

8:00 - 8:30 am

Networking Breakfast

8:30 - 9:45 am

Medical Devices

An overview of FDA regulations and guidance related to safety, effectiveness, manufacturing, and claims applicable to medical devices. 

Speakers

Marcia D. Howard, Ph.D., CAE, Vice President, Regulatory & Scientific Affairs, CHPA
Christina Kuhn, Senior Associate, Covington & Burling LLP

9:45 - 10:45 am

FDA Oversight in Cosmetics & Update on MOCRA

An overview of the FDA regulations related to safety, labeling, manufacturing and claims for cosmetics.

Speaker

Emily Manoso, Executive VP of Legal & Regulatory Affairs & General Counsel, PCPC 

10:45 - 11:00 am

Break

11:00 am - 12:00 pm

Dietary Supplements

An overview of regulations related to safety, labeling, manufacturing and claims dietary supplements. Dr. Hu will address FDA Regulation of Dietary Supplements and Duffy MacKay will cover the industry’s role in product integrity, safety, and informed consumer decision making.

Speakers

Haijing Hu, Ph.D., Chief, Regulatory Implementation Branch, FDA Office of Dietary Supplements Programs (ODSP)
Duffy MacKay, N.D., Senior Vice President, Dietary Supplements, CHPA

12:00 - 12:45 pm

Networking Lunch

12:45 - 2:00 pm

Advertising 101 for Consumer Healthcare Products

Overview or regulatory standards governing consumer health product advertising for OTC drugs, dietary supplements, and medical devices, including new guidance issued by the Federal Trade Commission regarding claim substantiation, social media, and use of influencers and lessons from the Food & Drug Administration and National Advertising Division of BBB National Programs.

Speaker

Raqiyyah Pippins, Partner, Arnold & Porter

2:00 - 3:00 pm

Quality Grand Slam: Exceeding the First Base of GMP Compliance

A review of the top five deficiencies related to OTC medicines and dietary supplements identified during regulatory inspections plus learnings from recent FDA regulatory action. Our goal is to share some insight, potential solutions, and to inspire continuous improvement for your quality systems.

Speaker

Fred Meadows, Senior Director, Regulatory & Scientific Affairs, CHPA 

3:00 pm 

Adjourn

Program questions