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Surgeon and author Jeffrey A. Singer discusses his article “The FDA’s outdated prescription rules are failing women and opioid users.” He argues that the U.S. Food and Drug Administration’s requirement for prescriptions for certain safe medications, specifically hormonal contraceptives and the opioid antidote naloxone, creates significant barriers to access and reflects outdated paternalism. Jeffrey highlights that obtaining prescriptions for birth control pills adds cost and inconvenience, disproportionately affecting women who report difficulty accessing appointments, despite decades of recommendations from major medical groups like the American College of Obstetrics and Gynecology and the American Medical Association for over-the-counter access, a standard in over 100 countries. He critiques the FDA’s slow and partial move to allow only one type of progestin-only “mini-pill” over-the-counter, contrasting it with the easier access to emergency contraception. Similarly, Jeffrey discusses the years-long delay in making naloxone available over-the-counter, despite its proven safety, effectiveness by laypeople, availability in other countries, and requests from experts and even the FDA itself, noting how manufacturer financial incentives and state-level workarounds preceded the eventual, partial FDA approval for the nasal spray form.
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Transcript
Kevin Pho: Hi and welcome to the show. Subscribe at KevinMD.com/podcast. Today we welcome Jeffrey A. Singer. He is a surgeon and an author. Today’s KevinMD article is an excerpt from his book, Your Body, Your Care, and the excerpt is titled, “The FDA’s outdated prescription rules are failing women in opioid users.”
Jeffrey, welcome to the show.
Jeffrey A. Singer: Thank you for having me.
Kevin Pho: Alright, so tell us a little bit about yourself and then talk about the excerpt that you contributed to KevinMD.
Jeffrey A. Singer: OK, so I’m a general surgeon and I’m in private practice in Phoenix, Arizona. You probably could tell by my accent that I’m originally from New York, but I’ve been in Arizona for over 40 years.
And I’m also a senior fellow at the Cato Institute in Washington, DC. For the last eight years, I’ve scaled back my surgical practice to part-time, and I’m full-time at the Cato Institute. I do a lot of research, policy analysis, et cetera, in the health care policy space. And I just recently published a book—it goes live on April 8th—called Your Body, Your Health Care, in which I tied together basically all the areas I work on by the overarching principle of respecting patient autonomy.
Kevin Pho: All right. And there’s an excerpt from that book on KevinMD that was published: “The FDA’s outdated prescription rules are failing women and opioid users.” Tell us a little bit about this excerpt for those who didn’t get a chance to read it.
Jeffrey A. Singer: OK. Well, that comes from—I have a couple of chapters that deal with the FDA—and a lot of people are probably unaware that since 1951, the FDA has basically assumed monopoly status over deciding what drugs will be available prescription only and which drugs will be available over the counter. Prior to that, it was a decision that was made by the drug manufacturer. Obviously, the more complicated the drug and the greater the risk of something going wrong if a person doesn’t use it properly, the pharmaceutical company would stipulate to the pharmacist: don’t sell this unless they have a prescription from a health care practitioner, because that way it covers them. But starting in 1951, that became the FDA’s decision. And when you have a government monopoly making the decision, then it becomes subject to special interest pressures, to political considerations.
So I talk about in the book, for example, take the example of birth control pills. For something like more than 20 years now, the American College of OBGYNs, the American Academy of Family Physicians, and more recently the American Medical Association have all said oral hormonal contraceptives can and should be available over the counter; that you don’t need, unless you have some sort of pre-existing vulnerability, you really don’t need to go get annual Pap tests. You should just be able to buy it over the counter. And in a hundred countries, women can do that. But in the U.S., despite that, the FDA has made them prescription only.
And only recently, after a lot of pressure from different women’s advocacy groups, they finally made one brand of one type of oral contraceptive—the so-called mini-pill, progestin-only pill, the brand name is O Pill—they’ve allowed women to get that one over the counter. Now, that’s not a very popular type of birth control pill because even though there’s a slightly lower risk of blood clots than with the regular pill that has two hormones, if you miss it, you have to take it within a few hours of the time you originally took it every single day, or else you have to just start the whole cycle all over again. So it’s very inconvenient to use.
Another example, by contrast, is the emergency contraceptive; the most common brand name that people know is Plan B. The FDA approved that prescription only in 1999. And despite a large amount of again, physician groups, women’s advocacy groups, it took a while. It took an FDA advisory panel recommending it be available over the counter for all women regardless of age. And it took until 2013 and a U.S. District Court order to actually make them over the counter. In fact, when the FDA decided to make them over the counter, their decision was overridden by the Secretary of Health and Human Services, Catherine Sibelius at the time. So the only reason one could think of is political considerations, because you had the advisory groups, you even had the FDA itself agreeing with it, and it didn’t happen.
We’ve seen the same thing, for example, with the overdose antidote naloxone. That’s been around since the early seventies. It’s used by many people who are not professional health care practitioners. And in fact, in an FDA blog post in 2016, the FDA said, “We think this is ready to be moved over the counter, and we invite the manufacturers of naloxone to ask us to reclassify it over the counter.” Now, I’ve written about this: you don’t have to be asked. The FDA commissioner could just make the decision or, actually, according to the regulations, any interested party could request the FDA to look into it. But over the years, because of regulatory capture, the FDA has tended to defer to the pharmaceutical companies. And as long as they’re not asking, they don’t do anything about it.
Eventually, it got to a point where in the Trump administration, I think it was 2019, FDA Commissioner Scott Gottlieb said, “Now we don’t usually do this. We usually, if you want to make it available over the counter, we have to approve your labeling of the over-the-counter product. But we’ve taken the liberty of going to the expense of doing that for you. So we already have a label ready for you. All you have to do is make the formal request.” That’s how they were bending over backwards. Finally, they made it over the counter in 2023. But only the nasal spray version, which is actually still more expensive than the injectable. So many harm reduction organizations still use the injectable ’cause they’re on a very tight budget, depending on donations. And in most states, they have a workaround where if a doctor gives a standing order, they could buy the injectable types. In fact, in my state, Arizona, I volunteered to give a standing order to the largest harm reduction organization in this state so they could obtain naloxone auto-injects.
So anyway, these are just examples of how the FDA, just in that one area, deciding what’s prescription and what’s over the counter. And I also talk about in my book just the drug approval process besides, but this is just one area in which the FDA or the government, let’s say, is intruding on our autonomy.
See, when I was doing work in this area, it occurred to me that in all of the areas that I work on at the Cato Institute, it all deals with the interplay—not the patient-doctor relationship, but the government-patient relationship. And I start off, I introduced my book by pointing out that in our profession of medicine, you know, since for the last several decades, we’ve had it drilled into us that we need to respect autonomy, that we can’t do anything without informed consent. We gotta go over the risks, the benefits, the alternatives. And if a person refuses, even if we think they’re making a terrible mistake, we have to just respect that choice because they’re autonomous adults. And I’m limiting this discussion to adults here because it gets more complicated with minors and that kind of thing.
So anyway, that’s what we do. But that’s actually a relatively recent development. As late as the mid-20th century, doctors would not necessarily tell patients everything. They were very paternalistic. Sometimes they thought for their own good, they wouldn’t share information with them. So this is a relatively recent development. Meanwhile, when it comes to the government, the government doesn’t respect our autonomy at all. The government tells us what medications we can have access to to help ourselves. You know, there are medications that are available in other countries that the government doesn’t allow us to have access to in this country. People, some who have the means, sometimes travel out of the country to get certain medications or other kinds of therapies. The government tells us what kind of health care practitioners we are even allowed to get advice from through licensing laws, through scope of practice laws.
The government tells us not just medications, but what kind of substances we could put into our own body. So for example, when it comes to mind-altering medications, as far as the government’s concerned, it’s completely OK for an adult to alter their consciousness using alcohol. But if they try to alter their consciousness using cannabis or any other substance, at least on the federal level, well, then if they catch you doing it, they’ll lock you up and put you in a cage.
Same thing with harm reduction. So for example, if you decide to engage in a substance that the government doesn’t want you to engage in—let’s say an opioid or something like that—and you wanted to take advantage of harm reduction modalities to reduce the risk that’s associated with accessing a drug on the black market, such as syringe services programs or fentanyl test strips, things like that, the government on the state level will forbid you from doing that through what they call drug paraphernalia. So in five states to this day, as we speak—and a large state, Texas, is one of them—if you wanted, if you knew there was a neighborhood in your city where there tended to be a lot of people using IV opioids, you just wanted to see fewer people die of overdoses. So you went out there and started just handing out fentanyl test strips so at least people could test whatever they purchased to see if it’s got fentanyl and make decisions accordingly. You can get arrested because in those five states, that’s considered distributing drug paraphernalia, which is defined as something used to test an illicit substance.
So I get into all of these kinds of things in my book about how basically, at the end of the day, while we doctors now are very respectful of patient autonomy, unfortunately the government isn’t. And I conclude my book by making a call on our profession, our medical profession—since we get to be the spokespeople for this—to be the tip of the spear, to lead the charge for having the government get out of the way of patient autonomy and respect patient autonomy.
Kevin Pho: OK. So getting back to the excerpt, what are some of the reasons why the government isn’t allowing as much access to things like OCPs and to different forms of naloxone? Is it a purely political reason?
Jeffrey A. Singer: Well, when it comes to naloxone, I think a lot of it has to do with regulatory capture. The way our system is set up, if a pharmaceutical company sells something that’s prescription only, that’s usually covered by insurance, whereas over the counter is not usually. So, therefore, when you have a third-party payer—and we doctors understand how this works—pharmaceutical companies do just what we do. They charge a higher price than they would be charging if it was direct to consumer, because it’s sort of like a negotiation. You know, if you want to get paid , then you charge the insurance company plus, you know, a hundred or 200 or whatever, and then that gets you closer to what you think you deserve for it. So, when something moves to over the counter, now all of a sudden you gotta make the price competitive enough that people will buy it.
So I think that’s why the pharmaceutical companies weren’t in a hurry to ask for naloxone to be made over the counter. In fact, a couple of years ago, I was at Capitol Hill and for the Cato Institute, I had a Hill briefing before Congressional staffers making the argument that Congress should just—’cause Congress also could just pass a law saying the FDA is instructed that by a certain date, all naloxone will be available for over the counter. So, when the sales or the actually government affairs person representing a company that made the Narcan spray heard about the event, he attempted to contact me. He wanted to have coffee with me in advance of the event, and I told him, “Well, I can’t. I’m in Arizona.” Which kind of, fortunately for me, that worked out. But I said, “But you can come to the event and we could talk there.”
So after the event was over, he pulled me aside and said, “I just want to explain to you why it shouldn’t be over the counter.” I said, “OK, I’m listening.” He says, “Well, because the over-the-counter price”—now remember, this is their retail list price—”it’s $145. Whereas if it’s prescription only, then the patient will only have like an average $15 copay.” And I said, “Yeah, but most of the people living on the street using drugs aren’t concerned about copays. They don’t have insurance.”
So anyway, eventually what made them finally request to make naloxone over the counter is when a generic manufacturer of naloxone from another country—I think it was an Israeli company—applied to the FDA for over-the-counter naloxone. And the FDA made an announcement saying, “We’re reviewing this application. And if it turns out that we decide that this over-the-counter application is eligible for over the counter, then we don’t see any reason why any other currently existing brands of naloxone nasal spray also shouldn’t be eligible for over the counter.” So they were basically kind of sending a message to the makers of Narcan that, “We’re gonna probably allow this to compete with you over the counter, and you could continue what you’re doing, or you could, you know, get with the program because you’re liable to lose significant market share.” And then all of a sudden, the Narcan manufacturers requested that their product be made over the counter too.
Right? And so now there are a couple of different brands of naloxone nasal spray that you can get over the counter. And it still, because it’s only one form, nasal spray, it just so happens the method of administration is more expensive than the injectable. Unfortunately, the FDA didn’t approve the injectable naloxone for over the counter, so that still requires a prescription. Sure. In all 50 states, they’ve come up with a workaround. Some states they’ve allowed the pharmacist to prescribe naloxone injectable. In most states, what they’ve allowed for, including my state, is what they call a standing order. So if a physician issues a standing order for naloxone, then basically the physician says, “Any person wanting naloxone, just put it under my name as the prescriber.” And that’s how they’ve done a workaround.
But it’s also kind of, when you think about it, it’s kind of silly. Because the standing order is saying that this is OK for any patient, even those I have never seen; just put me down as the prescriber. So that just kind of allows you to comply with the requirement of prescribing, but it becomes sort of de facto over the counter.
Kevin Pho: OK. Now, does the administration matter in terms of FDA approvals, whether it’s a Democratic versus Republican administration? Do you expect any changes with this new administration that we have now?
Jeffrey A. Singer: Well, it does; it is political. That’s, for example, why during the Obama administration, even when the FDA approved the emergency contraceptive, the Obama’s secretary of HHS overrode the approval. So definitely the administration makes a difference. Our new FDA commissioner is Marty Makary. Pretty well known to most of us doctors. Recent author of Blind Spots. I’ve gotten to know him, and I actually had an event at the Cato Institute where I discussed his book with him.
My take on this is he’s much more open to innovation and to allowing—he’s kind of a market-based guy. So I think he’d be more amenable to the idea of allowing new products to be over the counter. But, you know, I can’t get into his brain, but based upon what I’ve seen by what he’s written in the past and some of his previous positions, I think he’d probably be more open to the idea of making things that are currently prescription only over the counter.
Kevin Pho: All right, so this excerpt is from your upcoming book. It’ll be published by the time this episode goes live, Your Body, Your Health Care. Tell us the audience for the book as well as some of the key messages.
Jeffrey A. Singer: OK. Well, the audience is basically an informed, educated general audience. So throughout the book, obviously, I have to get into policy to explain my points, and I also get into proposals, both ideal and more realistic based upon the political reality. So I’m not trying not to be dogmatic. So, you know, I’ll mention what I think we should do, but I’ll also take into consideration that that may not be realistic at this time. So here are some steps in the right direction.
But I try to keep it as jargon-free as possible because a lot of people reading this, I’m hoping, will not be from the medical profession. And I try to bring in as many of my own experiences as a clinician as possible to kind of help illustrate my points.
And if there could be one takeaway that I would hope would happen from this is, even if people who read this book may not agree with all of my policy proposals—they may think maybe I’ve gone, maybe it’s a bridge too far for some people, that’s fine—but if I can get them to appreciate that every single day, the government is basically intruding on our autonomy as adults. And I approached issues of health care, and in fact all issues that deal with the interaction between people and the state, from the presumption of liberty and autonomy. So in other words, I tend to think of it as, if the FDA approves a drug for me to use, let’s say over the counter, it really is that the FDA got out of the way of my right to use that drug over the counter. We start with the presumption that I’m an autonomous adult who is sovereign and I own my body and I make my own health care decisions. And then from there, we interpret all government actions as basically interfering with that. That’s the way I approach things.
And if readers, after reading the book, start reacting to news stories about, let’s say, FDA positions or any other government position that relates to health care, and they start thinking, “You know, actually they are telling me what I could put in my body. They’re telling me what medication I could have, even if they think that I’m making a big mistake.” It’s still my decision at the end of the day, and if I got people at least appreciating that, then my mission is accomplished.
Kevin Pho: We’re talking to Jeffrey Singer, who is a surgeon and author. The KevinMD article we’re talking about is titled, “The FDA’s outdated prescription rules are failing women and opioid users.” It’s an excerpt from his book, Your Body, Your Health Care. Jeffrey, let’s have some take-home messages that you want to leave with the KevinMD audience.
Jeffrey A. Singer: Again, I encourage people, if they read my book, to realize that we are autonomous, sovereign adults, and that whether the government is well-intended or not, and whether the government is right or not, at the end of the day, we should be the ones making decisions about what medications we can take—’cause we have the right to self-medicate—and what substances we could put into our own bodies, as long as, of course, we don’t interfere with the rights of others. And we also have the right to decide who we want to get medical advice from, even if the government hasn’t approved those people that we choose to get medical advice from. That we have to approach all these issues from the presumption of autonomy and liberty.
Kevin Pho: Jeffrey, thank you so much for sharing your perspective and insight. Thanks again for coming on the show.
Jeffrey A. Singer: Thank you.
