Fady Boctor on Rx to OTC and Health Cost Reductions

Author(s): Scott Douglas Jacobsen

Publication (Outlet/Website): The Good Men Project

Publication Date (yyyy/mm/dd): 2024/09/12

Mr. Fady Boctor is the President and Chief Commercial Officer of Petros Pharmaceuticals. He has over 20 years of experience in the pharmaceutical industry, across a wide array of functions including brand and portfolio marketing, sales channel optimization, product portfolio strategy development and new product launches. Mr. Boctor has driven significant revenue growth for specialty biologics, mainstream Men’s Health product lines, rare/orphan disease therapeutics, and substance abuse rescue modalities. Mr. Boctor has worked for companies such as Forest Pharmaceuticals, Auxilium Pharmaceuticals, Endo Pharmaceuticals and Adapt Pharmaceuticals (Emergent Biosolutions). Mr. Boctor has his BA in International Relations from Hamline University, Masters in Diplomacy from Norwich University and his MBA from the University of Manchester Business School.

Scott Douglas Jacobsen: Today, we’re with Fady Boctor, President and Chief Commercial Officer at Petros Pharmaceuticals. You’re bringing E.D. therapeutic over-the-counter products to the market and developing pathways for future therapies. Some of these involve many neologisms. When you’re working as the head of Petro Pharmaceuticals, what are you doing to develop a pathway for future OTC therapeutics over time?

Fady Boctor: There are a couple of key points to highlight. One aspect is the prescription-to-OTC market, where we take a product that’s already a prescription medication—mature, well-established, and currently only available by prescription—and switch it to over-the-counter. That’s half of our effort. The other half involves innovative medications never considered for over-the-counter access. It’s an entirely new frontier, a new horizon in the prescription-to-OTC transition.

So, to put it differently, you might recall products like Mucinex or Claritin, which were once prescription-only but are now available OTC. Since 1974, we’ve seen about 104 such switches, covering roughly 50 years. That’s about 100 products that have transitioned from prescription to OTC. While that’s a significant portion, we’re looking to take this further by developing products that couldn’t switch without some technological assistive device or innovation—enhancing their potential for appropriate self-selection by consumers, eliminating the need for a prescription or a medical intermediary, and expanding access to critical medications as over-the-counter options.

That’s the nuance of our mission: transitioning prescription medications to OTC, but with a particular focus on innovative medications that require technological advancements to make them suitable for OTC. We’ll delve deeper into this as we continue our conversation. One interesting point is that over the past 50 years, with just over 100 prescription-to-OTC items, the average is only about two switches per year.

Jacobsen: Has the transition rate from prescription to OTC increased or remained fairly stable and slow?

Boctor: Some might disagree, but it’s been fairly stable. Recently, this year, we saw Opill and Narcan switch from prescription to OTC, but many argue that should have happened long ago. We’ve generally seen an average of 2 to 3 switches per year and, in some cases, none. From my perspective and analysis it’s been relatively stable. This might soon change with the recent technological advancements and the FDA’s opening of new opportunities.

Jacobsen: Why did the FDA decide to open that door? Typically, bureaucratic institutions like the FDA move slowly, so this decision must’ve taken a long time to materialize.

Boctor: That’s true. Since 2012, and even before that—though notably from a public milestone in 2012—the FDA indicated an interest in nonprescription utilization regulations, known as Nonprescription Drug Safe Use Regulatory Expansion (NSURE). They’ve explored and entertained this concept for more than ten years; some would argue even longer. What’s changed now is that we’re on the brink of facing a major physician shortage across the country. The U.S. is one of the most conservative and restrictive countries in the world when it comes to access to critical, chronic, pharmaceuticals, especially for diseases that are relatively easy to self-diagnose and self-manage.

For instance, if you have heartburn, you don’t need a physician to tell you to pick up an antacid. If you have a urinary tract infection, it’s fairly self-diagnosable, yet you still need a prescription to get the right medication today. COVID might have been a catalyst, highlighting that the American public wants to take control of their healthcare and mobilize without the restriction of needing a physician’s appointment. All these factors—the long-standing demand and the more recent COVID-influenced necessity—have driven the push to switch more products to over-the-counter status.

We can now add an assistive technology component to ensure safe utilization and expand the range of OTC candidates and prospects. 

Jacobsen: I’ve interviewed experts in evidence-based medicine. They often emphasize the importance of values and preferences in shaping the medical decisions that citizens want and ultimately make. The United States is quite different from other countries in this regard, as it places a higher value on autonomy and individual preference over equity. How does this shift in the market—this opening of pathways from prescription to OTC—affect the overall market dynamics and the corporate commercialization of these products?

Boctor: You’ve touched on a critical word there—autonomy. Autonomy, self-empowerment, and self-care are fundamental in this context. We’ve entered an age where, if you look at platforms like Amazon, you can buy something and have it delivered within 24 to 48 hours. It’s that simple. And in healthcare, the demand is no different. People want autonomy. They want empowerment. They want self-care.

Now, overlay that with the current U.S. healthcare landscape, one of the most restrictive healthcare environments globally. The clash is between this newfound American ideology of autonomy and self-care and the most restrictive healthcare system. The tension between these two forces is growing, and changes are imminent. 

Jacobsen: There are gray areas, however. At what point is it reasonable for individuals to make self-diagnoses and feel empowered? At what point does this empowerment cross into dangerous territory, where self-diagnosis might be harmful because it lacks the expertise required to make such decisions? That’s such an important and complex topic to navigate.

Boctor: Absolutely. Let me frame it this way—it’s fascinating how you can address two issues simultaneously. You can empower the consumer to engage in self-care without putting the entire responsibility of self-selection in their hands. That’s where technology-assistive devices come into play. They help solve many of the concerns you’ve raised.

How do we ensure that consumers can diagnose themselves with a clinically validated tool already used in healthcare settings but now embedded in the technology available at a retail pharmacy for OTC use? The consumer may have symptoms, say x, y, or z. But before they act, they must interact with this technology, which, within five minutes, helps confirm their diagnosis. It also educates them on potential comorbidities that may require further follow-up with a physician. So, we’re expanding their knowledge base. The technology might, for example, suggest that what they’re experiencing could be a heart condition and recommend seeing a doctor for a cardiovascular workup.

That’s where we find the sweet spot. We can confirm and validate diagnoses, educate consumers about their health, and flag potential underlying conditions that warrant a doctor’s visit. The FDA will likely support this, but they will draw a hard line if these safeguards aren’t in place or the potential for harm exists. In that case, they’ll block us—and their conservatism is justified in those scenarios. They want to ensure that if we’re making a positive impact in most, if not all, cases, we can proceed. Otherwise, they won’t allow it.

Jacobsen: The FDA must consider numerous factors. For example, if a patient needs to be literate enough to properly read and understand a drug label for something that’s moved from Rx to OTC, that could be a concern. Which leads to the question of the FDA’s timeline, this window, is there a set time limit, like ten years, for companies to prove the efficacy of their OTC products before the FDA closes the door? Or will they keep it open indefinitely, basing decisions on emerging evidence? 

Boctor: So far, there’s yet to be a specific indication that the FDA has established a strict timeline. Did the FDA hire you to ask that question? Because one of the things they’ve been particularly emphatic about is addressing low literacy levels. That brings me to the next question: Do we have sufficient data from behavioural studies regarding low literacy in these contexts?

And how does the FDA assess the behaviour of these different groups, particularly those who may not fully understand the content? How can you make your product better understood by individuals with low literacy and other subgroups or special populations that might be particularly sensitive to your product?

You’ve touched on a key concern. There are sensitivities and cautions to consider, and it’s great you picked up on that. We are currently working hard to align with FDA and ensure these subgroups are included in our research around comprehension and safe use. As for the timeline, there’s no indication that this window is narrow. The first movers in this space will set the stage for the prescription-to-OTC switch for years to come. We’ll likely see some low-hanging fruit, like Claritin, Mucinex, and antihistamines, continuing to be switched in different formulations, such as Flonase, with different devices and variations. But we’re really talking about this new window you’re referring to, specifically called Additional Conditions for Nonprescription Use (ACNU).

The FDA is working on providing a definitive policy around this. It’s a proposed rule, with October of this year set as the timeline for public release. Once it passes as policy and as a formal program, we believe it will be here to stay. Potentially, dozens of products under prescription restrictions will gradually convert to OTC.

This is no small feat, and it’s not simple. Each product will likely take anywhere from 5 to 12 years to complete the necessary studies—studies that must demonstrate that the labelling is well understood, that consumers can appropriately self-select the product, and, crucially, that they will use it correctly without adverse effects. That’s the essence of the actual use trial. So, it’s a lengthy and complex transition, but as of now, there is no deadline for specific drugs or formulations to be transitioned.

Jacobsen: The literacy aspect is something I’ve read about in the Canadian Encyclopedia, which states that one in six Canadians are functionally illiterate. I don’t know if it is the same definition with how it’s used in the U.S. However, Canadians generally score higher on the PISA than the U.S. So if one in six Canadians is functionally illiterate according to a reliable source, I expect an even greater factor in the U.S., where it could significantly impact key life and health decisions. The FDA will certainly be more thorough in their assessments than an independent journalist might be. But you’re right to note the range of times—4, 6, 12 years. Which types of products will take the longest to convert? Which have the biggest hurdles ahead of them?

Boctor: It’s an interesting question. The class we’re currently working on—the PDE5 inhibitors, which include erectile dysfunction treatments like Viagra, Cialis, and our product, Stendra—is one of the most challenging. Cialis has been trying to go OTC, and Pfizer attempted to do just that over ten years ago. Some records suggest it might have taken them as long as 15 years to explore the transition to OTC for this class of medication.

So, as a prime example, this class is one of the slowest to convert. If we succeed here, it will open the door for other, less complex products. I don’t expect the other classes to be as difficult as this one, but the fact that this class presents such a significant challenge means that success here could pave the way for easier transitions in the future.

Jacobsen: Are there potential interactions or cumulative effects between substances that go from prescription to OTC, which might pose risks if not carefully managed? For instance, someone might need both medications in prescribed doses rather than just OTC. Is that part of the FDA’s considerations and the companies looking to make these changes for overall efficiency?

Boctor: Absolutely, that’s a great question. When we started this process, we closely examined the prescribing information for our product in this class. The restrictions typically focus on interactions with other prescribed medications. When we presented this to the FDA, highlighting warnings about concomitant use with other prescribed medications, they responded by broadening the scope. They instructed us to include warnings for prescribed and non-prescribed substances, including supplements.

So, to answer your question directly—yes, the FDA is considering everything under the sun to ensure that as other products transition from prescription to OTC, they are covered by comprehensive warnings and precautions. The entire market is now increasingly all-inclusive in terms of warnings and cautions.

Jacobsen: Could there be applications of information and communications technology, like an app, to make this process more efficient? I’m not necessarily talking about the distinction between prescription and nonprescription, Rx and OTC, or the doctor-patient relationship in terms of care, but more about a digital intermediary that could ease the transition. The upcoming and current physician shortage could mitigate some of the severity, especially in a virtual context.

Boctor: That’s a great way to put it. That’s exactly what it is. We’re developing a proprietary web app, but it’s far more complex because it falls under the software category of a medical device, which involves an entire encyclopedia of regulations, criteria, and specifications. It’s a web app designed to function as a learned intermediary driven by algorithms. As patients answer questions about their medical and medication history, the algorithm scores their responses similarly to how a physician or other learned intermediary would.

So, you’re correct—this isn’t a pure OTC switch where you grab the box, maybe read the DFL (Drug Facts Label), and hope for the best. These are relatively safe drugs, so even with some misuse, it’s unlikely to be life-threatening. However, with these nuanced drugs, the questionnaire serves as a critical decision-making tool. Even though we’re empowering the patient to make a purchase, we’re still qualifying them to ensure that gaps in their knowledge, layperson assumptions or misconceptions are captured and accounted for.

If someone isn’t an appropriate candidate for the product, the app will suggest they consult a doctor before using it and restrict them from purchasing it. That’s the beauty of this new frontier.

Jacobsen: If the patients will self-report their data through an external app to physician or medical facility databases, this might raise concerns about the security of their vital medical information on a potentially less secure platform.

Boctor: The platform is subject to all the same HIPAA cybersecurity standards required by the FDA for medical device approval, so that aspect is secure. We also don’t intend to host, save, or store private consumer information. We don’t integrate with any larger EHR (Electronic Health Record) systems, medical history databases, or medical records. That could change in the future, and those discussions are ongoing. This is still the nascent stage or genesis of this development. The future could involve integration with a patient’s medical history, where they could opt-in to access their medical records, making it easier to purchase medications without a prescription.

It’s strictly about answering questions as honestly and accurately as possible. To verify the patient’s identity, we have some qualification elements, including A.I. and machine learning, but we only must retain or host their information for that day.

Jacobsen: What impact do you foresee on reducing healthcare costs?

Boctor: The impact is potentially huge. One of the best resources on this would be the Consumer Healthcare Products Association (CHPA). They’ve conducted several studies on the subject, and the numbers are significant—likely in the billions. If I remember correctly, CHPA has suggested for smoking cessation Rx to OTC switches, that savings could be around $1.9 billion. I’d refer you to CHPA for more detailed information on that.

Speaking of smoking cessation and impact on healthcare costse, , increased utilization is likely intimately correlated with improved healthcare outcomes and costss. When nicotine products like Nicoderm switched from prescription to OTC, utilization for smoking cessation increased by 150 to 200%, which is majorly beneficial. Moreover, they anticipated a $2 billion social benefit for the healthcare market. As more people quit smoking, many associated health conditions—such as high blood pressure, cardiovascular issues, and respiratory problems—begin to improve almost immediately. Consequently, there’s a significant reduction in urgent care, emergency room visits, and serious emergency admissions. Their estimate suggests that the savings from just this one case could be as much as $2 billion per year.

Jacobsen: Have we covered all the relevant points? Is there any core area I’ve missed?

Boctor: You had some unique and insightful questions. We’ve covered it all. Thank you very much for your time. 

Jacobsen: Excellent. Thank you, Fady.

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In-Sight Publishing by Scott Douglas Jacobsen is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. ©Scott Douglas Jacobsen and In-Sight Publishing 2012-Present. Unauthorized use or duplication of material without express permission from Scott Douglas Jacobsen strictly prohibited, excerpts and links must use full credit to Scott Douglas Jacobsen and In-Sight Publishing with direction to the original content.