Explainer Episode 41 – Government Obstacles to Over The Counter Medicines

The Goldwater Institute’s Christina Sandefur moderates a discussion with the Cato Institute’s director of health care policy Michael F. Cannon, on the role that the federal government plays in requiring prescriptions for medications. If you would like to read more from Cannon, see his and Jeffrey A. Singer’s white paper, Drug Reformation: End Government’s Power to Require Prescriptions.


Although this transcript is largely accurate, in some cases it could be incomplete or inaccurate due to inaudible passages or transcription errors.

[Music and Narration]


Introduction:  Welcome to the Regulatory Transparency Project’s Fourth Branch podcast series. All expressions of opinion are those of the speaker.


Host:  Hello and welcome to the Regulatory Transparency Project’s podcast. Today, we are excited to host a discussion on Michael F. Cannon and Jeffrey A. Singer’s white paper, “Drug Reformation: End Government’s Power to Require Prescriptions.” First, our moderator, Christina Sandefur, is the Executive Vice President at the Goldwater Institute.  She develops policies and litigates cases, advancing health care freedom, free enterprise, private property rights, free speech, and taxpayer rights. Christina is a co-drafter of the Right to Try Initiative, now federal law, which protects terminally ill patients’ right to try safe, investigational treatments that have been prescribed by their physician but are not yet FDA approved. She has won important victories for property rights in Arizona and works nationally to promote the Institute’s Private Property Rights Protection Act, a state-level reform that requires government to pay owners when regulations destroy property rights and reduce property values. Christina is a graduate of Michigan State University College of Law and Hillsdale College. 


Michael F. Cannon is Cato Institute’s Director of Health Policy Studies. Cannon is “an influential health care wonk,” Washington Post says; “ObamaCare’s single most relentless antagonist” from New Republic; “ObamaCare’s fiercest critic,” says The Week; “the intellectual father” of King v. Burwell, says Modern Healthcare; and “the most famous libertarian health care scholar,” Washington Examiner says. Washingtonian magazine named Cannon one of Washington DC’s “Most Influential People” in both 2021 and 2022. Cannon hold an MA in economics and a JM in law and economics from George Mason University and a BA in American government from the University of Virginia. He is a member of the Board of Advisors of Harvard Health Policy Review and the Federalist Society Regulatory Transparency Project’s FDA & Health Working Group. Christina, over to you.


Christina Sandefur:  All right. Well, thank you. And today, we’re going to talk about government’s power to require prescriptions for medications. And I’m really excited to talk about this topic because, Michael, I was thinking this is probably the health care topic that most affects every single American. I think everybody has had some kind of encounter, some kind of story about trying to obtain prescription medication, and I think we all probably have some frustrations with this system as well. 


But I’m not really sure that many people understand why certain medicines require a lengthy visit to the doctor rather than just running down to the pharmacy and picking up a drug. And I also think that people probably don’t understand that it wasn’t always that way, and it wasn’t the case that the law required people to get a prescription before they were able to get medicine. So let’s start by just talking about that briefly. When did the government start requiring prescriptions for drugs, and why?


Michael F. Cannon:  So this is a really interesting story. And thank you for agreeing to do this podcast and talk about our paper. The — you’re right. It wasn’t always the case that the government imposed prescription requirements. There were prescription requirements before that. Drug manufacturers would offer some drugs to patients over the counter, and others — for others, they would require patients to go to a doctor or some other clinician in order to purchase certain drugs because they were more dangerous and required some medical expertise to use. 


It came about — or the existence of government-imposed prescription requirements came about almost by accident. It was back in the early 1900s that Congress passed the Pure Food and Drug Act. And at the time, when Congress was deliberating about this law, there were a lot of people who said that, hey, wait a second — or maybe I should back up. There was a tragedy called the Elixir Sulfanilamide tragedy that led to 105 people dying from the Elixir Sulfanilamide. It was not because of the active ingredient in the drug but because of the solvent that the manufacturer used. And as a result, Congress passed legislation to require drug manufacturers to get government approval before they could market a drug. 


They had to prove to the government that the drug was safe. And this was a really — and there was debate over whether this would take away the right to self-medicate. And proponents of the legislation said that, no, it will not lead to government taking away the right to self-medicate. It will not lead to government-imposed prescription requirements. But as a result, one of the unintended consequences of the law is that it did because the law imposed some really stiff labeling requirements on products that drug manufacturers wanted to sell to — directly to consumers over the counter but exempted drugs from those labeling requirements if the manufacturer marketed them to — only to physicians or marketed them only by prescription. The law, despite the authors’ assurances that it would not lead to government-imposed prescription requirements, it ended up doing exactly that, and the FDA then claimed the power to require prescriptions for certain drugs. 


And the — Congress, then, ratified that about 40 years later when it passed the Durham-Humphrey Amendment to the Food, Drug, and Cosmetic Act. And this was sort of — this was really ironic because the tragedy that led to the creation of government-imposed prescription requirements was the Elixir Sulfanilamide tragedy, and, as I said, more than 100 people died from that medication, but — including 34 children, but the vast majority of them got it from a doctor. They were taking that medication under a doctor’s prescription. The doctors were not being careful enough about the drug that they were giving to these patients, and as a result, 105 patients died. I think it was 95 percent or 95 of them took it under a doctor’s direction. So not only did Congress — did sort of the — Congress inadvertently create this power, the FDA seized it without explicit Congressional authorization. 


But it was a really — it is a power that would not have prevented the sort of tragedy that gave rise to the legislation that ended up creating it. And that — in that tragedy, you can see why this government power — or why giving government this power really does not make patients any safer. 


Christina Sandefur:  Yeah, it seems like the history of drug regulation, federal drug regulation, follows that kind of pattern. You have some sort of tragedy, and then what comes out of it is a regulation that seems to kind of take advantage of the tragedy but doesn’t actually address it or wouldn’t have prevented it. But when the FDA was first formed, it — we were living in a time when people probably didn’t have access to the kinds of the information that they do today about treatments, and I think a big charge of the FDA at that time was just to — like you said, labeling — right? — to make sure that people understood what it is that they are taking, what was in the drugs and medications they were purchasing. So isn’t that a good justification for a government prescription requirement because your average person — even though your average person today might have a lot more information about a medicine — I don’t have a medical degree, so I have no idea how a particular medicine might work for me or whether it might interact with other drugs that I’m taking. So isn’t it a good thing that government wants to require people to go consult with a medical expert before they take medications?


Michael F. Cannon:  On the surface, that seems imminently reasonable. Unfortunately, there are two — at least two factors that come into play that actually make patients less safe. One of them is that when the FDA said to manufacturers that you can either market your drugs directly to consumers, and then you have to include all of this information that we’re requiring you to include, which is very costly, putting all that information on a drug’s label and then keeping up with the changes in those requirements. Or we can make it a lot simpler. You can market the drugs directly to physicians. 


What that did was not only give the FDA the power, in effect, to require prescriptions, encourage a lot of manufacturers to switch drugs from over-the-counter status to prescription status in order to avoid that regulatory burden. It also meant that consumers were getting less information from the manufacturers about those drugs. The law prevented manufacturers from marketing those label — or marketing those drugs to consumers with information that was intelligible to consumers. They wanted it to be intelligible only to physicians. And, so, here you have the law of unintended consequences coming into effect, where a regulation that was supposed to give consumers more information by requiring them to go consult with a physician inadvertently left them with less information and left them more ignorant about how drugs work. 


The second factor is, as the Elixir Sulfanilamide tragedy suggests, when you require consumers to go see a physician, that doesn’t mean that all is well. That doesn’t mean that everything is going to go well. Oftentimes, physicians are not very careful about the prescriptions that they issue. There’s not only the Elixir Sulfanilamide tragedy that suggests this. There’s other economic research that shows that physicians prescribe more potent drugs than consumers would choose for themselves. And because consumers like you, Christina, are aware of their own ignorance, and this is their own body that they’re talking about and that we’re talking about here that’s at risk. And, so, they generally are more conservative in their drug consumption when they are the ones making the decisions and less conservative, more risk-seeking when they go to — when they consult with a physician because they have a physician’s blessing on whatever drugs they consume. 


Christina Sandefur:  Yeah, I think that makes a lot of sense, Michael, because think about — I think about when I do research, I want to — my Keurig broke, and I needed to update it. And I must have spent 45 minutes on the internet reading reviews about different replacements. Right? And — but then when I go to a doctor and I’m sick and I need a prescription, I think a lot of times we just — we don’t go home and Google the drug. Maybe sometimes you do, but typically, I think your doctor just says, “Well, you have x, and you need y and here you go.” And I always spend a lot more time during research on electronics or where to have dinner than we do on what drugs we’re putting in our bodies. 


Michael F. Cannon:  Yeah, that’s weird. And it’s a little scary. And studying health — study health policy long enough, and you’ll listen to what the doctor says, but then you’ll also want to go do some Googling because you’re aware of dynamics like this. And I’ll give you two examples, one kind of pedestrian and one really tragic, of this dynamic. One is a study that was done of women in Seattle who took — who self-evaluated for whether they were — for whether oral contraceptives were appropriate for them. So they got some information about oral contraceptives, and they filled out a questionnaire. 


And then, they made this decision for themselves about whether they would begin taking the pill. But, then, the same women’s profiles were shown to physicians, and the study — or the researchers conducting this study gathered those physicians’ views about whether the pill would be appropriate for these women or whether they would prescribe it for them. And it turned out that the women were more conservative in their decisions. They took greater account of the risks of oral contraceptives and were less likely to choose to take the pill than the physicians were to prescribe it for them. So there’s another piece of evidence that consumers are generally more conservative about their drug consumption when they are the ones making the decision without a clinician prescribing drugs to them. 


But also the other big tragedy, drug tragedy in the United States, and actually worldwide, led Congress to give the FDA more power was thalidomide. This was a sedative and antiemetic that physicians were prescribing to lots of people but also pregnant women. And it helped with morning sickness. Unfortunately, it also led to severe birth defects and death among fetuses and infants. And in the United States, every single woman who took thalidomide did it under the — under a physician’s prescription because it was not available over the counter, and the physicians did not ask enough questions about — was this being — has this been studied in pregnant women? Are you studying this in pregnant women? What are the effects on the mother and fetus? — and these sorts of things. 


Again, this was, as you mentioned, this is another example of the sort of cycle of how the FDA accumulates power. There is a drug tragedy that Congress — and then, Congress responded to it by giving the FDA powers that would have not prevented that tragedy. But it is another example of how going — just because you’re going to a physician, that doesn’t mean that your drug consumption is going to be safe. In many cases, it can be riskier.


Christina Sandefur:  Yeah, that’s makes a lot of sense. And actually, I think the reason we don’t — that it first isn’t intuitive to us is because we’re talking about two different questions here. There’s the question of the information and the science behind the particular treatment, and, yeah, obviously, that will come from the manufacturer and the doctor and whatever else. But then, there’s your individual risk tolerance. Right? So do I think that the benefits of taking a particular drug when they described to me will outweigh the potential risks? 


And I think that’s something, to your point, Michael, that a patient may be, more or less, risk adverse. That’s an individual question. That’s not really a scientific or medical question. That’s more of just an individual preference question that might get sort of overridden if we’re not doing that independent analysis. So other reasons, though — you’re — this makes a lot of sense about the safety discussion, but I, in my work as well as you in yours, I’ve tried to remove some what I see as needless barriers to people’s ability to take the medicines that they want. And when you try to do that, a lot of times you hear people say, “Well, if you don’t have a prescription requirement” — even if it would be safe or safe enough for somebody to take this drug over the counter — “if you don’t have a requirement for a prescription, then you’re going to discourage people or not encourage people to go to doctors regularly.” 


So you hear this sometimes for women’s well visits to the gynecologist, and they’ll say, “Well, the reason that we want birth control to require a prescription is because we want women to get regular checkups to make sure that they don’t have cancer or something else going on. And if you just let them go get birth control at the pharmacy, they’re not going to see their doctors.” Same thing with even eye contacts. Right? They say, “Well, if you could just go get your contacts without having to go to an eye doctor, well, then you’re not going to go get an eye exam and someone might not notice that you’ve got macular degeneration or something like that.” So what are your responses to that reason behind requiring prescriptions for particular drugs?


Michael F. Cannon:  Well, if that rationale makes sense, why not require prescriptions for band aids and Q-tips and aspirin and anything just to get people into the doctor’s office so they can get a battery of tests. Those tests, those services that doctors provide should stand or fall on their own. They should be able to — if those services, those tests that they want to administer to patients are economically justifiable — that’s means that the health benefits are so great that they justify the cost — they should be able to sell those on their own without having to trap patients in their offices by requiring them to come there in order to get a prescription for the pill. And if you — I don’t think that there’s a safety rationale for using prescription — government-imposed prescription requirements in this way, to serve some other health need. Other — those — as I say, those other health needs should stand and fall on their own. 


And here’s a point that I think we really should emphasize is that all of the research that has been done on the — whether government-imposed prescription requirements make patients more or less safe finds that it — they — those — giving government that power makes patients less safe. Poisoning deaths increased after the FDA assumed this power. When you compare other countries to the United States or countries that imposed prescription requirements versus those that don’t, that you don’t get more health. Patients are not safer in the countries that impose those requirements, and that is true even of medications that have externalities like antibiotics. Imposing prescriptions for antibiotics does not appear to make patients less safe than having government not impose those prescriptions. 


Christina Sandefur:  Yeah. And it’s interesting because when you’re talking about forcing somebody to go to the doctor in order to get a prescription for their own well-being, I think oftentimes people forget that there is another choice. Right? Sometimes, people will just forego treatment altogether because they can’t afford the doctor or they can’t afford to take the time off of work to go see the doctor or whatever else. And the one that always kind of comes to mind for me on that is strep throat. So you mentioned other countries. I think that’s another thing; unless you’ve traveled a lot, people are probably unaware that there are countries that we would consider less free than the United States that actually don’t have these stringent government-required prescriptions. 


And strep throat just always — there’s — I know there’s many other countries that don’t require you to go to a doctor to get a prescription before you can get treated with an antibiotic for strep throat, and it seems to me like something that is extremely painful. It’s extremely dangerous. If you don’t treat it, it can lead to very serious health consequences, and yet, it’s very easy to diagnosis. Right? There’s a test for it, very easy to diagnosis. And we have treatments readily available, whether it’s — what? — penicillin or amoxicillin or — easy-to-get treatment. So you have other countries; you have even a Veterans Administration that allows people to just go to a pharmacy and take a test and, if they have strep, get treated. Whereas, here in the United States, I think because it requires a doctor’s visit, there’s probably a lot of people who don’t actually get treated for strep throat or don’t get treated early enough and then suffer more severe consequences. 


Michael F. Cannon:  That can be the case, and you can — I was going to draw a parallel to other areas that the FDA puts 00:22:10 in the way of diagnostic tests and treatments. And aside from prescription requirements, the premarket approval requirements that exist for diagnostic tests and drugs and devices, those might make the products that make it to markets safer, higher quality, by weeding out or blocking from the market some low-quality products. But those requirements come at the cost of delaying access to those products and suppressing the development of other beneficial products so much that, on balance, what all the research suggests is that the FDA is regulating in the realm, in — to an extent that it is causing more harm, at least at the margin, than it is preventing. And I think that when we look at prescription requirements, it’s the same story that we’ve been telling when it comes to the safety standard that the FDA imposes, the efficacy standard the FDA imposes on entry into the market for pharmaceuticals, for example, that, yes, in theory, you could be saving some lives by preventing some harmful consumption. But when you look at, not just those — the reduction in Type I errors but the much greater increase in Type II errors, we see that patients are less safe, not more safe.


Christina Sandefur:  Yeah, when we talk about reforming some of these systems, especially for treatments like strep throat or other medicines that we think are very important for a broad sector of the population to have access to, I think some of us that are kind of familiar with this issue are familiar with efforts to deregulate. We assume, well, it’s probably folks on the left who are in favor of these types of regulations, and it’s probably folks who are more libertarian-leaning or on the right that are against them. But there are — that’s not always the case. And I’m thinking, specifically here, of the birth control pill, which we’ve alluded to a little bit, but there are some — I don’t know — dozens, hundreds — you probably know the number — of countries that don’t require a prescription for birth control. We do require that here in the United States. 


And what’s interesting to me is that this is a drug where even many of the doctors who — whose — who would want to encourage people to come see them — right? — who would want to hold the prescription hostage, as they say, to get people to see them and to pay them, most OBGYNs seem to be in favor of making birth control available without a prescription. And yet, it doesn’t seem — we’ve seen some reform, but we don’t seem to be able to get that done in the United States. And I don’t think it’s quite so simple as, well, the right wants it and the left doesn’t or something like that. So can you kind of break down what exactly is going on with birth control specifically and how politics might play into that?


Michael F. Cannon:  Right. So thank you for raising this issue because this is absolutely a fascinating illustration of how the — giving government this power ends up not serving patients, and it also illustrates the really interesting political dynamics behind the — how government uses power and also the politics of the United States in general. It’s a fascinating window. And there are multiple types of birth control that I think we should talk about. There’s the pill, which we’ve mentioned. There’s also Plan B emergency contraception, which is the morning-after pill. 


But let’s start with the pill. It’s been around — daily-use oral contraceptives have been — they’ve been around longer. They’ve been around for 60 years, when the FDA approved the first pill. Women are very familiar with this product. And as you say, it is available without prescription in 100 countries around the world. There — in 100 countries around the world, women are freer than they are in the United States to buy oral contraceptives because they don’t have to get permission from a government-appointed gatekeeper. They don’t have some government gatekeeper standing between them and the medication that they want. 


And the politics — and, so, this is really absurd. We’ve mentioned already that women tend to be more careful when they’re making the decision for themselves about whether to use the pill than if a physician is making that decision for them. And, so, there’s just no reason to keep this drug on — to give it prescription-only status. The — as I say it’s been around for 60 years, available for — without a prescription in more than 100 countries, and there is political support for moving it to over-the-counter status in both political parties. At least, they say — both political parties say that that’s what they want. 


There are two leading bills in Congress — one Republican, one Democratic — that say that we’re going to promote over-the-counter use to daily-use oral contraceptives — over-the-counter access to these drugs. And — but if you look at both of the bills, you’ll find they don’t do anything of the sort. In both cases, what the Democratic legislation and the Republican legislation do is they say to the FDA, “Please give this expedited consideration.” Congress could move this product to over-the-counter status tomorrow. Congress could repeal the FDA tomorrow and with it all of these requirements, but rather than legislate, what both of — what members of both parties are doing is they’re deferring to the FDA. And that’s as if they’re not really interested in moving this product to over-the-counter status. And that’s fascinating. 


I — we could explore what are the potential reasons why, but even though — I think the takeaway is that, even though there’s — it’s a very popular issue, both political parties are afraid to actually do anything about it. They would much rather, at least members of Congress, would much rather punt this issue to the FDA. Now, it has been the case that the FDA has tried to move contraceptives to over-the-counter status, and the political dynamics there have been fascinating too. We could talk about what happened with Plan B oral contraceptives under the Obama administration.


Christina Sandefur:  Yeah, yeah. So let’s — not to make this all about oral contraceptives, but I think that is an interesting story. Let’s delve into that just briefly, regarding Plan B. I think it wasn’t that long ago, but I think that people may not be as familiar with this story or also how it kind of fits in with these regulations. 


Michael F. Cannon:  Right. So when — after daily-use oral contraceptives made it onto the market, some physicians theorized and began encouraging women to use those products in the following manner: by taking a higher dose right after unprotected sex. And they found that, hey, wait a second; we think this is preventing pregnancies. They studied — there were studies that showed that it does prevent pregnancies when you use the products in that manner after unprotected sex. And, so, some drug manufacturers started marketing a new product with the higher dose of the hormones that are in the pill for use the morning after unprotected sex. And eventually, the FDA approved this product. We call is emergency contraception or Plan B. And initially, it was available only by prescription. 


But because there was such a push — and this push was coming from the left; it’s important to note this push was coming from the political left to remove that prescription requirement in order to make it easier for women to access this drug. And if you think about it, it makes sense. If this is a drug you have to take within a certain narrow window after having unprotected sex, it’s going to be really hard to get to a physician, get an appointment, get the prescription, go get it filled, and take that product within that window. So there’s a big push by the political left in order to get rid of that prescription requirement. And the safety data really made the case for them. The New England Journal of Medicine said that the only negative side effect, I think, was heavy menses, and that was it. And that there are lots of over-the-counter drugs that have much more serious side effects than that. 


So the FDA in about 2012, I think it was, moved to eliminate all prescription requirements on the pill.  There was — on the morning-after pill. There was — they chipped away at the prescription requirements, allowing over-the-counter access to, I think, women aged 17 and older, and there was even some pressure by the courts for them to do so because people were filing suit. But it was in 2012 the FDA said, okay, we’re going to get rid of all prescription requirements. This is — we’re going to have unrestricted access to Plan B, morning-after contraception. And the Obama administration stopped the FDA from doing this. 


Secretary of Health and Human Services, Kathleen Sebelius, overrode the FDA’s decision. Now, this was remarkable. Why? If the political left was pushing — first of all, it’s remarkable because it was the left, which we usually associate with more government, that was pushing to deregulate this product. Why would — and then, if that was the case, why was a left-to-center president and his Secretary of Health and Human Services blocking that step that so many in their political debate — their political base desired? Well, it turns out that they were afraid of a backlash from the right. They were afraid that, if President Obama — on President Obama’s watch the FDA moved morning-after contraception to full, unrestricted over-the-counter status, that President Obama’s Republican opponent, who it looked like would be Mitt Romney, would be able — in his 2012 reelection race would be able to say, “President Obama wants 12-year-old girls to have sex, wants to make it easier for 12-year-old girls to have sex.” 


And, so, what Secretary Sebelius said was there isn’t — I’m stopping this move because there isn’t enough data about whether 12 year olds can understand the labeling of this product. And President Obama himself went in front of the cameras and said, I don’t think we want this product out there next to bubble gum and batteries. And, so, while you had at least a sizeable chunk of the political left in the United States that wanted Congress to deregulate, you also had a Democratic president stopping deregulation because the Republicans were even more anti-deregulation than he was. And he was doing it to protect his — or to improve his chances for reelection. And, so, here you have — women had a purchase this drug from any manufacturer who’s willing to sell it to them directly. And here you have both the Republican party and a sitting Democratic president denying women this right for political reasons. 


And that is why I think the politics of this issue — the politics surrounding this issue are fascinating, and they tell us a lot about politics in the United States nowadays. Happily, a federal court, after more than a decade of trying to get full, over-the-counter access to Plan B, a federal court forced the FDA to remove all prescription requirements. And, so, now, it is available next to bubble gum and batteries, and it’s a very safe product that women can access without having to go to a doctor. 


Christina Sandefur:  Michael, that story, I think, illustrates a really important point. A lot of times, folks will say, “Well, patients shouldn’t be able to — they need to have prescriptions, or they need to have government-approved treatments before they can take them because patients are too biased. They’re” — now, you’ve talked about studies that kind of show the opposite, but people will say, “Well, maybe they’re so desperate they’re not going to properly consider the risks, or they’re not going to properly understand the consequences and — because they’re too close to the issue of their own health, so we need somebody who’s sort of unbiased and doesn’t have a stake in the game to make these decisions.” And this example that you just gave illustrates that there are no unbiased actors in this process. And the government makes medical decisions — makes decisions about whether people can access medicines without prescriptions, especially safe and important medicines, based on politics sometimes. So I think it’s a really important point. And there are so many examples of this sort of thing happening, so, even when the best interests are at heart, even if we assume that most bureaucrats do have — purport to have people’s best interests at heart, what does that mean? There’s no — you can’t remove bias from this process.


Michael F. Cannon:  And the — another thing that you’ll hear is that slick drug industry marketing will manipulate women and other patients. Well, you know what? They have slick marketing that manipulates the politicians that make these decisions as well. We could talk about the example of Naloxone. That’s another one. And — but it’s not just that they’re manipulating or the political considerations are leading — are manipulating the politicians who make these decisions, but the FDA bureaucrats who, in the case of Plan B, were trying to do the right thing. 


Even they are — have biases that lead them to take steps that are not in the interest of patients. And we’ve talked about these before, which is delaying approval of beneficial medications because they’re afraid that they will look bad if that drug ends up being — having side effects that they didn’t foresee. So you’re absolutely right. It’s a question of who watches the watchmen, and there appears to be no better guarantor of patients’ safety here than individual freedom and letting patients make these choices themselves. 


Christina Sandefur:  Yeah, well, so, I think there’s so many more topics and subtopics that we could delve into here, but I think you’ve made a really strong case for individual freedom and medicine when it comes to prescriptions. So what — I guess the last question I want to ask you is what does that world look like. So what would happen if we really did eliminate all government-mandated prescription requirements and give people the freedom to take the treatments that they want to take? What does that look like in the United States?


Michael F. Cannon:  I think we would have much broader access to beneficial medicines at a much lower cost, and that would improve overall health. And part of the way that it would — one of the ways that it would do that is that manufacturers would innovate with new ways to provide patients the information they need to decide whether a medicine is right for them. So that you would not have this binary of either it’s over the counter and I read the label and then I’m on my own, or I go to a doctor, and who knows if the advice that doctor is giving me is accurate and it’s going to benefit me. In the paper that I wrote with my Cato colleague and your Goldwater Institute colleague, Dr. Jeffrey Singer, we talk about innovations like kiosks that you could go to in drug stores or elsewhere that dispense medications that, without a physician prescription, but that might give you a little more information and gather some information about you to see if that drug is right for you. Those kiosks could ask you about your medical history. They could ask you about other drugs that you’re taking. They could even take your blood pressure and heart rate, and — or you can even imagine them taking your BMI and then asking you to sign something or attest that you did understand the information they provided to you. That would be a much quicker, lower cost way of providing patients access — or providing patients information about medications that they might not get if they go to a physician’s office and at a much lower cost than going to the physician’s office. It could also help protect the drug manufacturer from liability because they could say if there were a patient who misused a product and then there was harm, the manufacturer could say, “Look, we dispensed it under these circumstances. They answered these questions for us, and, so, we did not breach our duty to that patient. We were being careful with them.” This is just one of these sort of innovations that we can imagine. There are going to be others that we cannot. And if we get rid of the government’s power to impose prescriptions, then drug manufacturers, pharmacists, pharmacies, drugstore chains are going to be pushing to keep finding ways to give patients the medicines they need at a cost they can afford with appropriate safety measures so that we can’t eliminate the risks of taking medicines, but so that we can minimize; it’s certainly relative to what it is today. 


Christina Sandefur:  Well, Michael, thank you so much for what I found to be a very fascinating discussion about an extremely important topic. And I know we’ve only just scratched the surface, so if folks want to learn more about how prescriptions interact with drug costs or things like that or a little bit more about the history of how government-mandated prescriptions came to be, I highly encourage you to check out Michael and Jeff Singer’s paper. I’m sure we’ll have links available to that. And thanks so much, Michael, for the discussion. And thank you to The Federalist Society.


Host:  And thank you, Christina Sandefur and Michael F. Cannon, for joining us today. And thank you to our audience as well. For more content like this, please visit regproject.org. That’s regproject.org. Thank you. 




Conclusion:  On behalf of The Federalist Society’s Regulatory Transparency Project, thanks for tuning in to the Fourth Branch podcast. To catch every new episode when it’s released, you can subscribe on Apple Podcasts, Google Play, and Spreaker. For the latest from RTP, please visit our website at www.regproject.org.




This has been a FedSoc audio production.

Michael F. Cannon

Director of Health Policy Studies

Cato Institute

Christina Sandefur

Executive Vice President

Goldwater Institute

FDA & Health

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