News: The FDA ACNU Final Rule, effective May 27, 2025, begins a New Era of Access. Let the BxA Solution help you unlock market opportunity.
Empower Healthcare Consumers
and Expand Treatment Access
Do you have the right strategy...
Additional Condition for Nonprescription Use (ACNU)
The ACNU Rule ushers in a new opportunity to increase treatment for many common and chronic conditions with nonprescription access to drug products that otherwise would require a prescription.
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Undertreatment and drug non-compliance are significant issues in the U.S. healthcare system, contributing to poorer health outcomes, increased costs, and provider burden. FDA intends to mitigate this public health crisis with access to nonprescription drug products with an ACNU.
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Biograph has been an active pioneer – working alongside FDA for more than a decade – to shape the ACNU Rule. With dual insights about the policy and the market opportunity, we partner with industry leaders from concept to commercialization of new nonprescription products. With our healthcare expertise, we have engineered an efficient, cost effective, and performance-based approach to ACNU interventions. We call it the BxA Solution.
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Ready to explore opportunities in the new ACNU marketspace? Let's connect to accelerate your success.
Senate Committee on Health, Education, Labor & Pensions (HELP)
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June 4, 2025
Hearing with Dr. Corrigan-Curay, Acting Director of CDER, FDA
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Partnerships & Alliance Network
Biograph works in partnership with Amwell
Since 2021, Biograph and Amwell have collaborated to bring digital care capabilities to Life Sciences applications, with a focus on regulated programs like ACNU. Working together, the Biograph and Amwell teams connect strategy with the data and digital care systems necessary for successful implementation and sustainable program performance at scale.
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In partnership with Amwell, Biograph clients are able to access the digital capabilities of the Amwell Converge™ platform and apply them to support digital care initiatives.
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Amwell is transforming hybrid care delivery, connecting and empowering providers, payers and innovators to improve outcomes and make care more accessible to all. Its cloud-based Converge enablement platform was designed to digitally enable a single, unified, scalable healthcare experience for in-person, virtual and automated care. The Converge platform provides the flexibility for clients to build their optimal hybrid care model and stakeholder experience – leveraging just one component or a combination of many components, all working together seamlessly across the platform.
Biograph is a Network Partner of Nicholas Hall
Biograph is a strategic partner and shares a mission with the Nicholas Hall Group of Companies to advance consumer healthcare in North America and around the globe. Together, we publish thought leadership, host industry learning events, and advise industry leaders on strategic initiatives. We have collaborated on the Rx to OTC Switch of high performing brands, working with companies across the industry.
Nicholas has been integral to the evolution of Biograph from its early, strategic approach to next generation Rx to OTC Switch, and he continues to be a trusted advisor to the development and innovation for nonprescription access.
Biograph is an event partner for the annual Nicholas Hall North America CHC Conference.
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Check out past conference highlights.​
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Alliance Network
The Biograph Commitment
Brand Performance and Business Impact
Our vision is the transformation of healthcare consumerism to an experience that empowers each individual, facilitates access to treatment, and builds loyalty and satisfaction.
Our mission is to accelerate brand and business growth by helping clients to connect data,
services, and technology to transform the consumer experience of healthcare.
Guiding our work is ongoing interaction with FDA and an understanding of the intention to
empower consumers to manage their everyday health, as articulated in the forthcoming ACNU
and PMI rules.
Unique Insight
Policy
Access
Digital Care
From direct dealings with FDA, Biograph offers first-hand insights about how digital care can improve treatment outcomes and product performance.
The Biograph team is a leading authority on access strategies, including Rx to OTC switch and nonprescription product approval under FDA’s new rule for Nonprescription Drug Product with and Additional Condition for Nonprescription Use (ACNU).
Biograph is a first-mover to frame a digital care solution that addresses FDA’s pending rule for Prescription Medication Information (PMI). The PMI rule is intended to improve public health by providing patients with clear, concise, accessible, and useful information about a prescription drug product.
Let's Connect!
We look forward to working with you to deliver new levels of performance and impact
