New book covers essential lessons of Rx-to-OTC switch

RAPSRAPS' Latest | 30 September 2021 |  By 

More than ever, consumers are looking to over-the-counter (OTC) medicines for treatment options that are easily accessible and often less costly than prescription alternatives. The OTC market in the US is growing. Sales are expected to grow from the $25 billion spent in 2013 to an estimated $42 billion in 2024, a 68% increase.

When a prescription medicine is reclassified to be made available without a prescription, it is known as an Rx-to-OTC switch. In such cases, the US Food and Drug Administration (FDA) must ensure these medicines can be used safely without direct guidance from a doctor or other qualified healthcare professional.

The Rx-to-OTC switch process can be a challenge, and each case is unique. RAPS’ new book, Lifecycle Management Through the Rx-to-OTC Switch, US Considerations and Perspectives to Advance Self-Care, was developed to help regulatory professionals better understand the process and learn from real-life examples.
Several of the book’s 17 authors and its lead editor participated in a virtual ‘meet the authors’ session during RAPS Convergence earlier this month, answering questions and sharing their experiences.
More to Rx-to-OTC switch than FDA guidance
FDA’s guidance on the topic amounts to a mere 20 pages, said Robert Falcone, senior manager, regulatory affairs, Prestige Consumer Healthcare, who served as lead editor and author. “There’s very little guidance, and all of a sudden, when you start going through the process…you realize, whoops, this is more complex. This is more difficult. This is more challenging.”

Leaders in many organizations may not fully understand what’s involved and why it can take 5–7 years to go from application submission to market. This was part of the impetus for the book, said Falcone. The idea was to give regulatory professionals both a handbook for making a switch and a reference they can use to show internal stakeholders what’s involved, how long it will take, and the expenditure required.
Every switch is unique
Part of the challenge of an Rx-to-OTC switch is that each case is unique. “If you've done one switch, you've done one switch,” joked author, Paul Wardle, founder, Beacon Associates LLC. Much of the book is devoted to case studies. “These were entities that went through the process,” said Falcone. “They all have a different feel to them. They all have different challenges,” added Wardle.
What will consumers do?
The key difference between a prescription and a nonprescription drug is the need for a doctor’s counsel. In a potential switch, “FDA has already reviewed that drug, and FDA has determined that that drug is both safe and efficacious, but under the conditions of being prescribed by a learned intermediary,” said author, Susan Levy, founder and principal, Susan B. Levy Consulting LLC.

In the switch process, FDA wants to know what happens when the learned intermediary is removed from the equation. “Philosophically we're really not talking about safety and efficacy. We’re really talking about consumer behavior,” said Levy.

The drug’s benefit has already been established in the intended population, but if it becomes available over the counter, consumers outside that population gain access. “The challenge that brings is those that weren't intended to have it in the Rx is where there's the least amount of data,” said Wardle. “That's what we're evaluating in the switch. How bad could it be if they did it wrong?”
A business case for the switch
“The other really important point for regulatory professionals to understand is that not every drug that's switchable should be switched,” said Levy. There must also be a business case for the switch. “Making sure that the drug is going to be commercially successful, doing studies in advance, making sure that the indication is meaningful, is just as important.”

“From a commercial standpoint, less than half of products that switch actually achieve the commercial expectations their sponsors have,” said Wardle. “That doesn't mean to say they weren't valuable switches, and there are plenty on the market today.”

“Unlike a prescription drug, where the sales go away when the patent expires, with OTC products, you can create a brand equity that endures into perpetuity,” said Levy.
Learning from failed switches
Not all Rx-to-OTC switch candidates make the switch. “I would say less than a quarter of things that people start talking about a switch actually ever make it to a submission and get to an approval,” said Wardle.
“Most of the time we don't know what's failed, so we collect anecdotal evidence on things we've worked on,” said Levy. “But there have been cases in the public domain. They've gone through an advisory committee, and we can understand a little bit about the failure to switch.”

It’s important to scrutinize the potential issues that could result from a switch, advises Wardle. If someone working on the switch identifies a possible problem, “don't be surprised if it gets raised within the FDA,” Wardle warns. “And the absence of an answer to a question will often lead to a delay or problem down the road.”

Lifecycle Management Through the Rx-to-OTC Switch, is available in print and e-book versions for $125.00 for RAPS members, and $175 for nonmembers.


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