Convergence: FDA officials tout open door policy for ACNU nonprescription pathway

Editor's note: This article was updated with an additional quote from one of the speakers and to correct a name.

PITTSBURGH — US Food and Drug Administration (FDA) officials invited industry to discuss options for using a new approval pathway that broadens consumer access to nonprescription drugs and offered tips for potential applicants during a 9 October session at RAPS Convergence 2025.
 
FDA’s final rule on new nonprescription drug products with an additional condition for nonprescription use (ACNU) was published in December 2024 and it became effective on 27 May this year, after delays in implementation when the Trump Administration froze new rules and regulations.
 
The session featured FDA officials speaking live remotely and consultants with Klick Health who appeared in person at the meeting in Pittsburgh.
 
“The purpose of this rule is really to increase options for industry to develop and market nonprescription drugs,” said Elisabeth Walther, associate director for strategic initiatives at FDA’s Office of Non-Prescription Drugs (ONPD).
 
Long in development, the rule outlines requirements for products that may be used by consumers without oversight by a healthcare provider, but which are not suitable for over-the-counter (OTC) sale. (RELATED: Facilitating self-directed care: The FDA’s proposed ACNU rule, Regulatory Focus 8 December 2023). Applicants may apply through ACNU at any point in a product’s lifecycle and opt to sell a product by prescription and ACNU concurrently.
 
The ACNU is a real game-changer to help products get over that goal line to nonprescription where it’s not possible with labeling alone, said Theresa Michele, MD, ONPD director.
 
“I want to emphasize that our door is open in our health care system and for consumers, and we want to see more of them,” said. “Nonprescription drugs play an increasingly vital role in our healthcare system and for consumers, and we want to see more of them. We're particularly excited about ACNU.”
 
“So, if you're considering nonprescription development, do come talk to us,” Michele added. “We are happy to work with you throughout your development.”
 
As with traditional nonprescription drugs, consumers healthcare practitioner supervision is not required, but unlike OTC products, companies need to ensure that consumers appropriately self-select and understand labeling. There is an additional step where customers complete a questionnaire to self-select, demonstrating their understanding through a mobile app and/or device, and then purchase from a secure website.
 
“The consumer isn't going to be able to just pick this drug off the shelf at the pharmacy and buy it,” Walther said.
 
The ACNU pathway is intended to improve access to nonprescription products and allow them to take control of some aspects of healthcare directly. Classes that come to mind with nonprescription sale include statins, hypertension drugs, oral contraceptives, antihistamines and asthma inhalers.
 
The first and most important consideration in nonprescription drug development is choosing the right drug, Michele told attendees. With some drugs, a healthcare professional is clearly needed to select the right treatment and monitor outcomes and adverse events, for example cancer chemotherapeutic agents, which have serious toxicities, Michele noted.
 
To determine if a product is right for ACNU, companies should ask themselves some key questions, Michele advised. For example, is a nonprescription drug needed in the market? Is the condition symptomatic and easily self-diagnosed by consumers? What is the drug’s safety profile and is it prone to misuse or abuse? Is monitoring necessary?
 
The perfect drug for ACNU would involve no lab testing or monitoring, very simple dosing and administration, very few serious adverse events, obviously no boxed warnings or risk evaluation and mitigation strategies, and minimal drug-drug interactions, Michele said. It’s rare, of course, to find a drug that meets all of these criteria, but this gives developers an idea of the difficulty involved in nonprescription development and ideas about areas to focus on, she added.
 
FDA recommends proceeding with a stepwise approach, the first and most important of which is to create complete labeling in drug facts label format (DFL), which is required for every nonprescription drug, Michele said.
 
“Generally, this means capturing all directions, contraindications, warnings, precautions and important drug direct interactions that are found in the prescribing information,” Michele said. “One of the biggest problems that we see in development for a prescription to nonprescription switch is cherry-picking the warnings and precautions you like and ignoring the rest, and that does not count as complete labeling.”
 
Step two involves optimizing labeling, which usually requires an iterative process with testing in step three to determine if consumer comprehension is adequate with labeling alone. And finally, if your consumer studies demonstrate that your labeling is insufficient to ensure consumer appropriate self-selection or actual use, then you would consider proposing an ACNU, Michele advised.
 
Some see the potential market for ACNU products as very promising, if untraveled. Session panelists from Klick Health noted that some 75 million Americans live in areas where there is a shortage of primary care doctors and individuals with disabilities have 85% higher odds of having unmet prescription needs.
 
“We know that nurse practitioners are trying to fill the gap, but more is needed,” said Aleks Lyons, senior director of consulting at Klick.
 
Chronic diseases like obesity, diabetes, heart disease and hypertension are common, yet underdiagnosed and undertreated – the numbers are staggering, Lyons said.
 
“The top four – obesity, hypertension, high cholesterol and arthritis – are chronic conditions that have complex care over time, and we know that individuals may have multiple chronic conditions,” Lyons said.
 
Research suggests that around 41% of the population would rather go to the doctor for everything, but on the other end of the spectrum, there's around 35% who would rather take control of everything, said Paul Wardle, senior vice president of innovation consulting at Klick.
 
“Now whether they should or not is a different question,” he added. “We have a system today which is kind of like: If it's nonprescription, you're pretty much on your own.”

"There is definitely interest in leveraging the ACNU NDA pathway to increase access to medication with multiple active programs. Astra Zeneca is or will likely be the first to apply as it has already completed key studies in support of its program for Crestor [(rosuvastatin)]," Wardle told Focus.
 
Nonprescription access has been shown to increase utilization of drug products by 30% the Klick consultants noted.
 
“For too long, we've thought about the hospitals, the clinics, the doctors, the payers, the insurance – but not enough about the patient needs,” Wardle said. “How do we encourage access in different ways? We can imagine the future, but it's up to us to own it and create those solutions.”