New book covers essential lessons of switching from Rx to OTC


More than ever, consumers are turning to over-the-counter (OTC) medications for treatment options that are easily accessible and often less expensive than prescription alternatives. The OTC market in the United States is growing. Sales are expected to increase from $25 billion spent in 2013 to approximately $42 billion in 2024, a 68% increase.

When a prescription drug is reclassified to be available without a prescription, it is an Rx to OTC switch. In such cases, the United States Food and Drug Administration (FDA) must ensure that these drugs can be used safely without the direct advice of a physician or other qualified healthcare professional.

The Rx-to-OTC switching process can be a challenge, and each case is unique. The new RAPS book, Lifecycle management via the Rx-to-OTC shift, US considerations and perspectives for advancing self-care, was developed to help regulatory professionals better understand the process and learn from real-world 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 on the Rx-to-OTC switch than the FDA guidelines

FDA guidance on the subject is only 20 pages long, said Robert Falcone, senior director, regulatory affairs, Prestige Consumer Healthcare, who served as editor and author. “There’s very little guidance, and all of a sudden when you start going through the process…you realize, oops, it’s more complex. It’s harder. It’s harder.

Leaders of many organizations may not fully understand what is involved and why it can take 5-7 years to go from application submission to market. It was part of the impetus for the book, Falcone said. The idea was to give regulatory professionals both a playbook for making a change and a reference they can use to show internal stakeholders what is involved, how long it will take and the expense involved.

Each switch is unique

Part of the challenge of an Rx-to-OTC switch is that each case is unique. “If you made a change, you made a change,” joked author Paul Wardle, founder of Beacon Associates LLC. Much of the book is devoted to case studies. “These are entities that went through the process,” Falcone said. “They all have a different feel to them. They all have different challenges,” added Wardle.

What will consumers do?

The main difference between a prescription drug and an over-the-counter drug is the need to see a doctor. In a potential change, “The FDA has already reviewed this drug, and the FDA has determined that this drug is both safe and effective, but under the conditions of being prescribed by a learned intermediary,” the author said, Susan Levy, Founder and Principal, Susan B. Levy Consulting LLC.

In the process of change, the FDA wants to know what happens when the learned intermediary is taken out of the equation. “Philosophy, we’re really not talking about safety and efficiency. We’re really talking about consumer behavior,” Levy said.

The drug’s benefit has already been established in the intended population, but if it becomes available without a prescription, consumers outside of that population have access to it. “The challenge with that is that the ones that weren’t meant to have it in the Rx are the ones that have the least data,” Wardle said. “That’s what we value in the switch. How bad could it be if they did it wrong?

A business case for the switch

“The other very important point for regulatory professionals to understand is that not all switchable drugs need to be switched,” Levy said. There must also be a business case for the change. “Making sure the drug is going to be commercially successful, doing studies in advance, making sure the indication is meaningful, is just as important.”

“From a business perspective, less than half of the products that change actually meet the business expectations of their sponsors,” Wardle said. “That’s not to say they weren’t valuable switches, and there are plenty of them on the market today.”

“Unlike a prescription drug, where sales disappear when the patent expires, with over-the-counter products you can build brand equity that lasts in perpetuity,” Levy said.

Learn from failing switches

Not all Rx-to-OTC switch candidates make the switch. “I would say that less than a quarter of the things people start talking about a change result in submission and getting approval,” Wardle said.
“A lot of the time we don’t know what went wrong, so we collect anecdotal evidence about the things we worked on,” Levy said. “But there have been cases in the public domain. They went through an advisory board and we can somewhat understand the failure of change.

It’s important to look at potential problems that could result from a change, advises Wardle. If someone working on the switch identifies a possible problem, “don’t be surprised if it comes up within the FDA,” warns Wardle. “And a question not being answered will often result in a delay or a problem down the road.”

Lifecycle management via Rx-to-OTC switch, is available in print and electronic versions for $125.00 for RAPS members and $175 for non-members.

© 2022 Society of Regulatory Affairs Professionals.


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