OTC Drugs

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

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

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?

• 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

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

• 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

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