The recently proposed ACNU rule seeks to enhance consumers access to nonprescription drugs by enabling direct access through innovative, yet undefined, mechanisms. By allowing enabling additional medications to be available non-prescription, it promotes easier access to essential healthcare products, potentially enhancing public health outcomes and health equity. However, a shift towards digitization raises different questions regarding safety and efficacy. Your team should be able to determine if and how your proposed ACNU will address them.”
- Discuss the benefits of ACNU, and how this rule will change the regulatory process
- Analyze the regulatory challenges associated with implementing ACNU
- Explore how the consumer will be affected by ACNU
- Debate whether software can be used as medical device documentation
Does ACNU qualify as Software as a Medical Device (SaMD)? If so, would the FDA expect SaMD documentation in the marketing application for this drug/device combination? SaMD documentation ensures software safety, usability, and validation to meet user needs. While consumer software doesn't always meet these standards, following SaMD processes can ensure ACNU's reliability and clinical validity for consumers.
- Discuss what regulators expect for SaMD
- Assess the importance of a quality software design process to achieve software reliability
- Determine how following SaMD can increase your team's overall success
There have been recent updates on OTC monograph reform as outlined in the CARES Act. This is a pivotal development that will have implications on the regulation and accessibility of nonprescription drugs in the United States. Your team should know what the recent changes mean for regulatory decisions.
- Discuss the key changes and updates in the regulatory framework of the CARES act
- Explore strategies to adapt and thrive within the changing regulatory environment
- Analyze the potential impact of OTC monograph reform on various stakeholders, including consumers, manufacturers, and health care professionals
Developing a Product for nonprescription status requires a melding of business, science and regulatory frameworks and opportunities. The general process is familiar to many in the consumer product industry and this session will outline the key steps, studies, decisions and obstacles for simple and complex switch strategies. This will set the stage for more in-depth sessions on important details and recent learnings.
- Uncover the established criteria traditionally used to evaluate switch candidates, such as indication, safety, target population and business case.
- Explore the key elements of a switch program, considering both regulatory requirements and development pathways, and explain unique studies required by the FDA and tech-enabled approaches.
- Discuss the components of preparing for the launch of a switched product, including manufacturing needs and retail strategies.
Our facilitated Interactive Discussion Groups (IDGs) optimize peer-to-peer learning by crowdsourcing solutions to common challenges surrounding deploying and scaling DCTs. The connections you make through the IDGs will become your most valuable takeaways
- IDG 1: Analyze Consumer Health Behaviors Post-Pandemic
- IDG 2: ACNU: Explore the intersection between technology and consumer healthcare
- IDG 3: Chart a Safety, Research, and Marketing Path to a Successful Switch
- IDG 4: Manage Complex Switches in a Digitalized World
The main question about FDA’s introduction and implementation of ACNU is whether it will have a broadening or limiting impact on drug access. Enhanced labeling, diagnostic testing, and increased technology can benefit consumers, but what drawbacks must you know about the new rule?
- Explore how ACNU can potentially open up new opportunities for consumers to access drugs
- Analyze the limitations that the ACNU rule may introduce, such as potential complexities in labeling or regulatory compliance issues
- Debate whether ACNU will influence the accessibility of drugs
As consumer behaviors continue to shift towards online platforms, e-commerce has emerged as a powerful channel for the distribution and sales of OTC products. This digital transformation has made changes in marketing, accessibility, and consumer interactions. How will these changes affect future marketing ideas?
- Review how e-commerce has reshaped marketing strategies for OTC brands
- Highlight the role of platforms, mobile apps, and website interfaces in simplifying product discovery
- Focus on the regulatory landscape for OTC products in e-commerce and how to address challenges related to product safety
The switch industry is expected to reach a valuation of $66.5 billion by 2033. However, there are certain categories of medication that should not be switched to an OTC status. Your team should be prepared to evaluate the feasibility, regulatory requirements, and necessary conditions to determine if pursuing certain switches is an achievable goal.
- Analyze the essential prerequisites, including regulatory, safety, and educational requirements, to make the switch a viable and safe option
- Discuss the potential benefits, accessibility improvements, and implications for public health associated with moving certain categories to an OTC status
- Assess the role of education, healthcare infrastructure, technology, and public awareness campaigns in ensuring a successful transition
Switching from Rx to OTC can be a challenging process, but what happens once the switch is completed? In order for your team to be prepared to handle these new challenges, you must explore the basics of substantiating OTC advertising claims. This includes examining the difference between express and implied claims, when substantiation is required for a claim, and how to ensure your evidence is a good fit for the claim.
- Learn what evidence is needed to substantiate clinically proven, clinically tested, doctor recommended, and health- related claims.
- Understand different types of comparative claims and the substantiation required to support them.
- Develop a roadmap for product testing and claim substantiation that will protect your OTC product from FTC and NAD scrutiny while also explaining the consequences for making false or unsubstantiated claims.
Transitioning medications from prescription to over-the- counter status involves a careful balancing act to ensure the product is meeting consumer needs but also making financial sense. Your team should understand how to license, research, optimize, and forecast your switch to minimize risk and maximize the reward.
- Quantify the risks associated with transitioning medications from prescription to over the counter status
- Weigh the financial elements of risk
- Plan and execute a risk-mitigation strategy
Marketing strategies for switches must be distinctly tailored to effectively communicate with both audiences. HCPs are very invested in the data behind a product, whereas consumers are interested in how the product can benefit them.
- Clarify the marketing challenges specific to HCPs including regulatory constraints
- Center importance of trust and clear communication while marketing to consumers
- Align marketing messages and create a cohesive campaign that resonates with both target audiences
Recent switches such as Opill and Naloxone have just entered the market as of 2023. Your team should be able to analyze the significant impact that these switches have on consumer access and healthcare, especially in the area of women’s health.
- Examine how recent switches have shaped the healthcare market
- Spotlight the regulatory process of these switches, and what allowed them to be approved
- Explore how these will open the pathway for new switch approvals in the market