Who Should Decide Whether Drugs Are Available Over-The-Counter or by Prescription?
In October 2020, Michael Cannon and Jeffrey Singer proposed ending the U.S. Food and Drug Administration’s authority to decide which drugs are available only by prescription. Their solution: leaving the decision to the drugs’ manufacturers. This Regulatory Transparency Project program featured Michael Cannon, former FDA official Joshua Sharfstein, and moderator Dan Troy discussing prescription drugs, nonprescription drugs, and who decides.
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]
Jack Derwin: Hello, and welcome to this Regulatory Transparency Project virtual event. My name is Jack Derwin, and I’m Assistant Director of RTP at The Federalist Society. As always, please note that all expressions of opinion are those of the guest speakers joining us today. To learn more about our speakers and their work, you can visit RegProject.org to view their full bios.
After opening remarks and discussion between our panelists, we’ll go to audience Q&A, if time allows. So please enter any questions into the Q&A box at the bottom of your screen.
Today, we’re pleased to host a conversation titled “Who Should Decide Whether Drugs Are Available Over-the-Counter or by Prescription?” To discuss this topic, we have a great panel featuring Michael Cannon, Joshua Sharfstein, and Dan Troy.
Dan, who will be our moderator today, is Chief Business Officer, Chief Administrative Officer, and General Counsel at Valo Health. Previously, Dan was Chief Counsel at the United States Food and Drug Administration. And with that, Dan, I’ll turn it over to you.
Dan Troy: Thank you. I’m really excited to do this. I should also mention that I co-chair the Regulatory Transparency Project’s FDA & Health Group, which Michael is a member of and is sponsoring this debate.
So, we’re really excited. I’m very excited to have both Michael and Josh here. Michael has some — and I’ll give a brief intro — is the Cato Institute Director of Health Policy Studies. He’s been named as an influential healthcare wonk. He’s been on virtually every network and major newspaper and in many academic journals. He’s the coeditor of a couple of books. He holds a B.A. in American Government from UBA, and an M.A. in Economics and a J.M. in Law from George Mason. And he’s going to start.
And then we’re very excited to have Josh Sharfstein. He’s Vice Dean for Public Health Practice and Community Engagement and a professor in the practice of Health Policy and Management at the Johns Hopkins and Bloomberg School of Public Health. He has served as Secretary of Maryland Department of Health and Mental Hygiene from January 2011 to December 2014.
He was famously the number two person, Principal Deputy Commissioner at the FDA from 2009 to 2011. He graduated from Harvard summa cum laude, worked on public health projects, graduated from Harvard Medical School, Boston Combined Residency Program in Pediatrics in Boston Medical Center Children’s Hospital and then a fellowship in General Academic Pediatrics, a member of the IOM and, as Josh notes, he is who my son, who is a medical — who is a budding doctor, wants to be when he grows up.
So with that said, Michael, you’ve taken on an issue that, in some senses, is almost as American as apple pie, right? We all grow up. And we know that if we’re sick we go to the doctor, and then the doctor gives us a prescription. That said, this morning I took Claritin. I take it every day. And when I was growing up, there was only Benadryl available. And I could not have taken Benadryl in the morning because it’s sedating, as opposed to non-sedating.
And as we face a Supreme Court that may overturn Roe, issues like the pill and Plan B take on increasing importance. So, Michael, tell us why, in your view, we shouldn’t stick with the status quo, trust our doctors and the FDA as gatekeepers to important medicines.
Michael Cannon: So, thanks so much, Dan, for the question, and FedSoc for putting on this event, and Josh, for joining us. This whole discussion came about because of a paper that we wrote at the Cato Institute — I wrote at the Cato Institute with a colleague of mine named Doctor Jeffrey Singer. He came to me one day with a question and a challenge like the one you’re asking, Dan. He said, “Why is the FDA deciding what drugs are going to be prescription-only, and what drugs are going to be available for consumers to purchase over the counter without needing a doctor’s permission?”
And he actually submitted a paper of some length on this. And I read the paper. And I thought this was coming from out of left field a little bit, because this issue does not get a whole lot of attention in health policy circles. But the more he and I discussed it, the more we read about instances of the FDA using this power for both good and ill, the more we realized this needs more attention. And that gave rise to this paper that he and I coauthored and published in 2020, called “Drug Reformation.”
And the idea is this: you want someone to be deciding what drugs are going to be available only on a prescription basis, and what drugs are going to be available to patients to purchase directly over the counter, without having to go to a doctor or other health professional. But when you give that power to the government, when you let the government make these decisions, you get all sorts of really unsafe decisions that the government ends up making.
For years the government required a prescription for Ibuprofen, for Naproxen, for Plan B emergency contraception and for some of the sorts of allergy medicines that you mentioned, Dan: Claritin, Zyrtec, Allegra. These are what we call the non-drowsy or non-sedating antihistamines. And they’re also current examples of the FDA requiring prescriptions for drugs that are safe for consumers to use.
I should mention about all of those drugs I just mentioned, the FDA required prescriptions for those for about 10 years. So that’s 10 years of requiring patients to go to a doctor and take time off of work and pay for the doctor’s visit and talk to the doctor and maybe have an unwanted medical encounter, just to get permission to use one of these medications. And that actually makes patients less safe if it blocks access to beneficial medicines for them.
There are current examples of the FDA requiring prescriptions for drugs that don’t need prescriptions. These include oral contraceptives, which have been — which 100 countries allow patients to access without a prescription; naloxone, which reverses opioid overdoses and can save lives. The FDA approved it on a prescription-only basis back in 1971. But Italy has allowed consumers to purchase naloxone over the counter since 1996, and Australia since 2016. The fact the FDA is blocking access to those drugs is making it harder for us to save lives when someone overdoses from opioid use.
But what really encapsulates this issue, I think, Dan, is the example that you raise, which is antihistamines. For more than a decade, the FDA imposed prescription requirements on those non-drowsy, non-sedating antihistamines. That steered patients toward the more dangerous allergy medications that you mentioned, like Benadryl and other allergy medications that do cause drowsiness.
So Benadryl and other sedating antihistamines, the Federal Aviation Administration says were a probable cause or a contributing factor in 63 airplane crashes from 1990 to 2006. Studies have linked them to thousands of automobile fatalities. And there are side-effects like seizures, hallucinations, and even death from accidental overdoses.
But the FDA allowed consumers to buy those drugs over the counter at the same time it was requiring prescriptions for Claritin and other antihistamines that don’t have any of these side effects. And so the whole purpose of giving to the government the power to require consumers to get a permission slip from a doctor before they can use certain medicines, the whole purpose of that is to keep consumers safe.
But what the FDA ends up doing, and what similar regulatory bodies in other countries end up doing is not just requiring prescriptions in ways that keep consumers safe, but often in ways that jeopardize consumers’ health, and steer patients, in many cases, in some cases, at least, toward more dangerous drugs, which makes them less safe, rather than more safe.
And you might say there’s an objection to what I’m saying here, which is that determining whether a drug is safe to switch takes time. But what the FDA is doing here isn’t science. The delays are not due to the FDA collecting data and then making the switches as soon as they have enough information to determine that the drug is safe.
Consumers in the United Kingdom could use these non-sedating antihistamines like Claritin about two decades earlier than consumers in the United States could. So they were available over the counter in other countries two decades earlier. So they were approved over the counter in the U.K. even before the FDA approved them on a prescription-only basis. So this is not science that the FDA is doing. The FDA is making these medical decisions for us, and making them in a way that leaves us less safe.
Dan Troy: So I’ll just note, from a libertarian perspective, that, actually, it is the manufacturer that checks the box and decides whether it wants to impose a prescription requirement. Schering-Plough could have made Claritin over the counter long before it did. But it didn’t.
Josh, I just, actually, was with someone who spent his whole entire career at Amazon. And one of the things he talked about was how when we talk about innovation, we should spend about 80 percent of our time understanding the problem and 20 percent of time on the solution. And I know that you and Michael agree a lot that there is a problem. So why don’t we actually spend some time on where you guys agree before we focus on what may be different solutions that you guys have. So what’s your perspective on Michael’s articulation of an issue or a problem?
Joshua Sharfstein: Well, first of all, thanks to both of you for being here, to Cato for hosting this. It’s great to have to this discussion. I noticed Michael used the term “discussion.” Dan used the term “debate.” I’ll go with Michael on that one. I think our goal is to have a discussion, and to do exactly what you just said, find areas of common ground, proceed on about our differences with civility. So I’m looking forward to it.
Just right off the bat, I’ll say I share concerns. And I’ve been very involved in issues with the sedating antihistamines. When I was the Health Commissioner of Baltimore, I led a petition that actually led to some of those products being removed from the market for young children — I’m a pediatrician — because of evidence of harm and no corresponding evidence of benefit.
I think of this topic today with two questions that we have to tease apart. One is, are prescriptions good or bad? And the second one is who decides whether a drug should be prescription or not? And I think we can find, I think, some common ground along the way.
So my answer to the first question — are prescriptions good or bad — is, it depends. We have to look at each medication. My yardstick that apply is public health, whether we’re healthier as a country with the medication available by prescription or over the counter. And, for me, part of this analysis is equity, whether there are groups whose health is particularly harmed by one decision or another.
With respect to individual medications, there are factors, I think, that should be considered when deciding over the counter or prescription. And those include the margin of safety, the risk for addiction, the risk of drug resistance, for example, with antibiotics, and the need for close clinical monitoring for a drug to be used effectively.
Now, many times prescriptions are necessary. But, in other times, I agree the greater access that over the counter provides is able to better promote health and even save lives. And that’s where I think we probably have some common ground. I also appreciated in the paper the idea that it’s not necessarily all — it doesn’t have to be all of one or all of the other. There are some intermediate steps that the United States could explore, including pharmacist access, which might make sense to maximize the benefits and minimize the risks of certain medicines in a more accessible setting.
So — and I think we’ll find some common ground on which medicines, like naloxone, we think should be over the counter. For the second question, who decides, I think the answer is FDA. FDA should decide based on a public health analysis with the kinds of factors that I talked about. But, as you pointed out, Dan, that’s not actually the system we now. The system isn’t that the FDA decides. Really, the companies play a central role. Because, just like you said about checking the box, they have to propose an OTC switch.
Now, I recently read somewhere, and I’m going to quote, “Drug manufacturers actively resist efforts to have the FDA switch their products or their competitors’ products to OTC status.” I’m going to read that again, “Drug manufacturers actively resist efforts to have the FDA switch their products or their competitors’ products to OTC status.” I read that in Michael’s paper. So, I think, if we’re thinking about letting the companies decide, or an empowered public health agency that can actually apply a public health set of criteria, I’d go with the empowered public health agency.
And let’s talk about some examples. Like you said, for antihistamines, actually, the companies didn’t want it to be over the counter during that period. It was an insurer that had to sue before it started to loosen up. In the case of naloxone, that’s another good example. FDA really wants it to be over the counter. And I’m just quoting from 2019, Acting Commissioner Sharpless, he issued a statement saying, “We design-tested and validated the key labeling requirements necessary to approve an over-the-counter version of naloxone that included putting together a model drug fax label.” They rolled out the red carpet for companies to submit an OTC naloxone application. And so the company didn’t.
There have been no takers. Leaving it to companies hasn’t worked. In fact, I noticed in Michael’s paper when Cato supported making naloxone over the counter, and I’m quoting again, “Four different lobbyists representing the manufacturer contacted four different Cato employees to press the manufacturers case for not switching this life-saving drug to over the counter.”
So, I think, I hope today we can agree that some medications do make sense to be over the counter, others by prescription. We can explore our, maybe, disagreement over who decides. But I don’t think we should let the companies decide. It’s like saying that a manufacturer of military hardware should decide where we’re going to invade. The key decision should be made by people who are responsible for the public interest, and, again, where is there common ground.
Michael wrote in his paper, “If the power to require prescriptions remains with the FDA, the agency should initiate switches itself and abandon its historic practice of waiting for the manufacturers to petition the agency to switch their products.” I agree. And, what’s more, I appreciate, as I said, the exploration of things in between all prescription and over the counter. I think that that’s also an area of common ground. I appreciate your interest in this, Michael. I look forward to the discussion.
Dan Troy: So, I agree. It is to be a discussion. And, so, Michael, do you have any thoughts?
Michael Cannon: Yeah. I think it’s important to clarify that the manufacturers have a voice in this, as they should. And in our paper we advocate that manufacturers should be the ones deciding whether they’re going to market their drugs as over the counter, direct to consumers, or on a prescription-only basis.
But it’s important to be clear here that that’s not the situation right now. The manufacturers do check a box when they apply for FDA approval of a drug. They say, “We want this to be prescription-only,” or “We want this to be over the counter.” And once they do that, the FDA uses the power the Congress gave it to require the manufacturer to sell the drug on a prescription-only basis.
The manufacturer can’t get out from underneath that requirement until the FDA lifts it, or until Congress lifts it. And so there are really interesting episodes of people trying to get that requirement lifted for all sorts of good public-health reasons, like making access to non-sedating antihistamines broader and cheaper so that more people can use them. And that could bring down not just the cost of those medicines, but also health insurance premiums, which is why WellPoint petitioned the FDA to move Claritin to over the counter. But the manufacturer has often pushed back against that.
In the case of Claritin and Schering-Plough, they argued against — Schering-Plough, the manufacturer of Claritin — argued against the WellPoint petition, asking the FDA to move Claritin to over-the-counter status. This was really interesting, because you had a manufacturer who said, “No. We don’t want to sell our drug directly to consumers on a broader basis. We want the FDA to keep requiring us to sell it only on a prescription basis,” which is interesting for a number of reasons.
One of them is, even if the FDA removed that requirement, they could still sell it on a prescription-only basis. They could make that part of the terms of the sale, that we are only going to sell these pursuant to physicians’ prescriptions. You don’t need the FDA to do that. But more important than that is, Josh, is that — or more interesting and ironic — is that, at the same time Schering-Plough was telling the FDA, “No. We want you to keep requiring us to sell this drug on a prescription-only basis,” it was selling the drug over the counter in other countries.
In European countries, Schering-Plough was selling Claritin over the counter. The U.K. is one of them. I mentioned that already. And they even used this drug’s safety record, its superior safety record compared to Diphenhydramine — which is Benadryl and other sedating antihistamines — as a reason why they should be able to market it over the counter.
So there is something going on here. And I think we all know what it is. They get to sell the drug at a higher price when it’s prescription-only, for reasons we can discuss. And they wanted to keep doing that in the United States. And they figured it would be easier to do that if the FDA were still requiring them to do it. But this is an example of the kind of gaming of this government, this power that Congress has given the FDA, and a type of gaming of that power that particularly harms consumers.
Dan Troy: And you want to trust the companies. Josh?
Michael Cannon: Oh no, not. No, no, no, no. But I can respond to that later. Go ahead, Josh.
Joshua Sharfstein: Yeah. I was just going to say that I think the position I’m taking would change the situation that you just described. If FDA were in power, and it could look at the science and say, “Sorry Schering-Plough. This should be over the counter and we need to give people access to it.” But what you’re saying is leave it up to the companies wouldn’t have changed the outcome at all. That’s what I’m not quite grasping. It sounds to me like you’re arguing for an empowered FDA to overrule companies when it is in the public interest.
Michael Cannon: So, no, I’m not doing that. I’m offering the Schering-Plough episode as an example of how the companies that manufacture these drugs can use the FDA’s — can abuse the FDA’s power to take away your ability to purchase drugs directly from manufacturers. The Schering-Plough and Claritin incident is not the only one.
We talk in the paper about Prilosec. In 2002, the FDA — the question before the AFDA was whether certain manufacturers or whether AstraZeneca would be able to sell Prilosec or omeprazole — which is a heartburn medication — over the counter. One of the manufacturers of the generic prescription-only version of omeprazole opposed that switch, because they figured they would lose market share in the prescription-only market if consumers were allowed to purchase this drug on an over-the-counter basis.
So there are multiple examples of manufacturers trying to use this power that the FDA holds to line their own pockets to the detriment of consumers, by making consumers pay higher prices, blocking access to medicines for them, and leaving them worse off in terms of health.
Joshua Sharfstein: So I’m asking, how do you — oh, sorry. I just think I’m not sure I disagree with your assessment that that’s what companies are doing, in some circumstances. I may agree with that. The question is, what do you do to fix that? And I think saying, “Actually, the FDA has no ability to make something over the counter, it’s all up to the company,” doesn’t get you there. What gets you there is the FDA having the ability to look at public health factors, and say, “This has got to be over the counter. I’m not interested in your market-share considerations. I’m interested in what’s in the best interest of people in the United States and their health.”
So I think where we agree, in part, is that there probably should be more things that are over the counter or on that spectrum. And I think the question really is how to create a system that gets us there while not overshooting the mark, say, and creating a lot of harm in the process.
Michael Cannon: Well, what we argue in the paper is that, yes, manufacturers should be the ones to decide whether to market their drugs on a prescription-only basis or directly to consumers or somewhere in between. Maybe they’ll require consumers for certain drugs to get permission from a pharmacist.
Maybe they’ll come up with novel ways of educating consumers about how to use their drugs, like kiosks where you can sit down, you can watch an instructional video. They can even give you a little quiz to make sure you understood how to use this drug. They could even take blood-pressure readings and heartrate readings or weight readings there. And if they’re very concerned about who is using their drugs, they could record personal information about who’s buying the drugs.
There are all sorts of ways that manufacturers could come up with to make their drugs more accessible and bring them to more patients in a safe way. But you need to get the FDA’s power to require prescriptions out of the way before you’re going to get those sorts of innovations. And we’re not, in the paper, arguing that we should just trust the drug companies to do the right thing, of course not.
There are going to be other things protecting consumers here as well: the pharmacies that retail these drugs, the threat of liability that the tort system poses for both the manufacturers and pharmacists who are not exercising due care when they sell these drugs to consumers. Those factors are going to be protecting patients. We’re not just saying, “Leave it all up to the manufacturers and everything will be fine.”
What will happen is, what we predict will happen if you take away the FDA’s power to require prescriptions, we’ll get a lot more of these sorts of innovations. They’ll make drugs more widely available. They’ll do so in a way that is safer than the regime that we have right now. And that’s that.
Dan Troy: Well, as flawed as the FDA may, on occasion, be in some of its decision-making, I’m not sure that the tort system is really a better system in which to trust. But I guess the real question — and I’ll turn it over to Josh — is, are you proposing to essentially throw the baby out with the bath water? You guys agree. I think we all agree that there are many occasions where the FDA has not exercised its authority appropriately. Or it may not actually have the authority that you guys think it should have.
But there’s a whole class of drugs that, I would say, hoping not to sound too paternalistic, that the average person is not really equipped to make a decision about whether they should or should not use that medicine.
Joshua Sharfstein: I think that’s true. And I think that Michael’s paper recognizes some of those things that we would agree with. Putting addictive drugs over the counter may not be the brightest idea, or drugs like antibiotics that can cause a lot of antibiotic resistance. Drugs with a lot of teratogenicity can cause problems, cause a lot of birth defects.
So I think that that’s true. I do think maybe we’re going to agree to disagree. I think my position is that if companies aren’t doing it now, they’re still not going to do it. The way to actually get more smart OTC conversions is to empower the FDA to get there.
But on this issue of the tort system, I actually think this makes the case even stronger, because the companies now have certain protections, as I understand it. And, of course, I’m only going to dip my toe into the legal side. But there is a learned intermediary doctrine that they can have a prescription. They have certain protections against lawsuits. These are additional reasons why they may not want to move to over the counter for drugs. And if it really does make sense and it’s in the public interest, I think it’s appropriate for the FDA to say, “Yes. You should do it.” And, essentially, the burden of that decision rests on FDA.
Dan Troy: Let’s talk for a second about something that I think you mentioned, Michael, which is the role of reimbursement. Now, this is not something within the FDA’s aegis. But for some reason — and maybe you know the reason, I don’t know the reason — our system has evolved where prescription drugs get covered by insurers, and, by and large, by and large over-the-counter drugs do not get covered by insurers. And, this, at least it seems to me, distorts a lot of manufacturer decision-making around this topic. So where does that come from, and how does that get fixed?
Michael Cannon: Yeah. So we talk about that a fair amount in the paper. When you remove a government-imposed prescription requirement, economic theory tells you the price should go down. I’m sorry, economic theory actually tells you the price should go up. But what happens is the price should — usually ends up going down when you remove that requirement. And the reason is that insurers are less likely to cover drugs that are over the counter. They sometimes do. But they’re less likely to cover them when you switch them from prescription-only to over the counter.
Therefore, when these drugs are less heavily insured, when the consumers are using them, are spending their own money instead of an insurance company’s money, they’re much more price-conscious. They will shop around more. And they drive down the prices of these drugs. Whereas, when an insurance company’s paying, the consumer doesn’t care about the price at all. The manufacturers can charge much higher prices. And prices for prescription drugs tend to be higher than they need to be as a result. We give a bunch of examples in the paper.
If you look at a dosage-equivalent basis, so, holding dosage constant, the price for prescription Ibuprofen is 30 to 50 percent higher than the price for non-prescription Ibuprofen. There should be no difference there. But it’s higher. And I think insurance explains the difference. With naproxen sodium, the difference is even greater, three to four times more expensive on a prescription basis than an over the counter.
And we even have data on oral contraceptives, which show that right when Obamacare’s mandate that employers and other insurers cover all FDA-approved oral contraceptives, right when that mandate kicked in, prices for hormones and oral contraceptives — which had been falling, relative to inflation — began to spike, and essentially doubled over a period of ten years or so, again, at the same time that this mandate made most of the market for oral contraceptives completely price-insensitive.
So one of the benefits of getting the FDA to move these drugs, more drugs from prescription-only status to over the counter is the prices of these drugs ends up falling. That expands access for these drugs. It holds down insurance premiums. Even if the insurers still cover them, the insurers are paying less for those drugs and it’s sort of an interesting twist, because, as I mentioned at the beginning, economic theory would tend to suggest that when you remove this implicit tax of a government-imposed prescription requirement, the price should rise. Instead, the price falls. We think it’s because of the influence of excessive health insurance coverage.
Dan Troy: So Josh, I imagine this is another area of agreement because [inaudible 00:30:26] . . .
Joshua Sharfstein: Yeah. I think there is some area of agreement here. I think the number one reason to move a drug for over the counter is ease of access for drugs that people really need to get at all times of day and night. And it’s just, it’s obviously going to be easier than having to go get a prescription. Although, frankly, that’s getting a little bit easier with telemedicine. But I think that that’s really the key consideration.
I think cost, all other things being equal, reduced cost is a plus. There are a couple of challenges, though, because if it shifts to people’s out-of-pocket payment and certain people can’t afford it, then you may have a different kind of access problem. So if somebody really needs a medicine, a lower price that they can’t afford isn’t as good as a higher price that insurance covers.
But, more generally, I think there are all kinds of problems with the way we have drug pricing in this country. I don’t think the solution to drug pricing is just to throw everything over the counter and see what happens. And I don’t hear Michael saying that. And I think there are some really important policy solutions to high drug prices that are really the most important things that we can be doing. But I do think there’s a potential benefit that comes alongside the increased access for drugs where it really makes sense to create more access.
And I think there are — I do think that, right now, for a lot of different reasons, I’m not sure FDA really feels empowered to do these switches. You can see them practically walking up to the line, knocking on the door, offering flowers and chocolates, trying to get naloxone over the counter. They can’t get the companies to bite. But I think, with some clarity on the FDA’s authority, some encouragement, and, I think, even without having to explicitly include costs, I think you’d get more switches of the right medicines that would, in the end, be helpful for people to have more access to.
Dan Troy: So let’s talk about a little, one of the things you mentioned, Josh, and that Michael does cover in the paper, is these intermediate solutions. So one of them that you mentioned was automatic switches, but intermediate classes of drugs. Also, perhaps the states having the ability to make something like naloxone more available. Josh, why don’t you sort of talk a little bit about, again, areas of agreement with [inaudible 00:32:45] . . .
Joshua Sharfstein: Yeah. Well pretty much every state has put in place a standing order for naloxone. So when I got naloxone at the pharmacy, I don’t need a special prescription for it. So the challenge there, though, as I understand it, is that that might work for the individual at the pharmacy. It doesn’t work so well for a harm-reduction group trying to get a lot of naloxone, because they’re going to be doing outreach and talking to people who are at the absolute highest risk of overdose.
And there are all different kinds of requirements for prescription medicine that just wouldn’t exist for over the counter. So I don’t think it’s the case that a consumer can’t go in and get naloxone. But it is not quite over the counter, and that would definitely have some benefits.
But remind me of your question, Dan.
Dan Troy: Talk a little more about, and let’s flesh out this intermediate class issue.
Joshua Sharfstein: Oh, intermediate class issue. So I think that pharmacists have proven themselves incredibly valuable for public health during the pandemic. Just think about the incredible access that people have to vaccination through pharmacies in this country. And pharmacists were huge public health partners to me, both when I was the City Health Commissioner and the State Health Secretary. I did so many projects with them that I got to be their graduation speaker once at the University of Maryland School of Pharmacy. So I have a special soft spot for pharmacists.
And I don’t — and there is a lot of evidence around what some people call medication-management programs, where pharmacists really help the patients understand what changes might be needed for their medicines or really understand the medicines. And so I think that there is probably more room in this country to have certain products that the pharmacists have some ability to counsel and make available to people, that would allow, for example, certain medicines maybe not to be totally over the counter because of the potential risks.
And so I would be open to that kind of authority being with FDA too, that maybe there is more than one option. I’m sure that there are some doctors out there who might not fully agree with me on this. When I was Health Secretary of Maryland, I was responsible for 24 or so professional boards, which were constantly fighting with each other over bounds of professional jurisdiction. And my view was like, we should be looking at what the public health interest is.
And that’s why I supported dental hygienists doing certain kinds of dental procedures that they could do, that they could be trained to do, because I thought it was really important for rural dental access in Maryland. So I think that with a few more options and some good criteria and a solid process, FDA could really explore this issue and potentially get the benefits of that.
Dan Troy: I should note, my grandfather, may he rest in peace, was a pharmacist. Michael, can you respond or react a little bit —
Michael Cannon: — Sure.
Dan Troy: — to some of the things that Josh has said. But can you talk particularly about — so the average American has, essentially, an eighth-grade reading level. And, actually, FDA does require that, for an OTC switch, that a label be written that is essentially comprehensible by someone with about that reading grade-level. Talk about the ability of consumers to really understand the very complicated products with a lot of risks, but a lot of benefits.
Michael Cannon: Sure. So we talk in the paper — pardon me — about intermediate reforms that Congress or the FDA could implement. One of them is a behind-the-counter category, which is essentially what we have with naloxone. Another is clarifying, as Josh says, the FDA’s authority to force switches, or to — not to force switches, but to remove its own requirement that the manufacturers sell a drug on a prescription-only basis.
These would be beneficial. They would restore people’s rights to make their own medical decisions. They would expand access to necessary drugs. But they don’t really go far enough in those directions. A good example is naloxone. Yes, you can walk into any pharmacy and buy naloxone because of these standing orders that Josh has mentioned, which helps get around the FDA’s prescription requirement. But you still can’t get them in vending machines.
They should be available in vending machines. They should be available in places like defibrillators are or fire extinguishers are. So if you see someone suffering an opioid overdose, break glass and then administer this nasal inhaler to them because you could save their life doing so. It’s just that safe that it should be available on those bases. But it’s not. And a behind-the-counter category wouldn’t facilitate that sort of access.
And even if we give the FDA — we could debate whether the FDA has the authority to move without the support of the manufacturer. I think the FDA could make naloxone available over the counter or remove the prescription requirement by itself. But I think it would also be a good idea for Congress to enact legislation clarifying that the FDA can do that. But, even if the Congress does that, this power is still going to be politicized. And two perfect examples are Plan B emergency contraception and routine-use oral contraception.
With Plan B emergency contraception, this is an incredibly safe drug. As a federal judge berated the FDA with the data, back in, I think, 2012, it was, after the FDA had spent — not just the FDA, but also HHS broadly and two presidents of both parties — had spent a decade delaying access to this drug for political reasons. On the right, conservatives don’t want this drug out there because they believe it’s an abortifacient, and might lead people to have sex in situations that they don’t want them having sex.
But, also, President Obama did not want to make Plan B emergency contraception available over the counter, not fully over the counter, in part, because he was afraid that if it were available alongside batteries and bubble gum, as the president said, then you could have very young teenagers purchasing this medication and using it. And he didn’t want — some analysts suggested the president didn’t want Republican attack ads saying that he was facilitating sex among young teenagers.
So what that ended up doing was, the politics of Plan B emergency contraception and abortion ended up blocking, leading the FDA and HHS to say, “Hey, this is not fair to say the FDA blocked it all this time, because there were a lot of FDA officials who opposed what the Bush and Obama administrations were doing.” Some of them even resigned in protest.
But having this power at the FDA allowed politics to capture it and prevent people from exercising their right to purchase this drug and the right of the manufacturers to sell it directly to people. The same thing is happening with routine-use oral contraceptives right now, or the pill. The FDA approved the pill on a prescription-only basis in back in 1960. It has been with us now for six decades. It has a proven safety record.
There are studies indicating that consumers, women, when they do self-evaluations about whether they are a suitable candidate for the pill, are more conservative than doctors are when prescribing the pill for those women. So there’s evidence that women will be more judicious in their use of the pill than doctors are when they’re prescribing it. Yet the FDA is still not moving the pill to over-the-counter status, I think, in part, because of politics. I don’t think it’s the manufacturers here.
I think it’s the politics of sex and reproductive rights that has prevented the FDA from making the pill over the counter, of Congress from forcing the FDA to switch the pill to over-the-counter status. If you look at both the leading Republican and Democratic bills that purport to make the pill over the counter, neither of them do that. They just beg the FDA to do it. And it’s because this is such political hot potato.
So, even if you gave the FDA more authority here, you would still have these sorts of political games waged by manufacturers, yes, but people who have other interests in your medical decisions. And that’s why we advocate just getting Congress and the FDA out of the business of making people’s medical decisions for them at all, and taking this power away from the FDA entirely.
Dan Troy: So Josh, I was part of the Bush 43 FDA. You were part of the Obama FDA. You don’t want to say anything about Plan B? It would be interesting to hear your reaction on at least, either Plan B or, again —
Joshua Sharfstein: — Sure, just [overtalking 00:42:08] —
Dan Troy: — or oral contraceptives. But, in general, how does the FDA avoid at least considering politics, given that it is necessarily a political agency run by a political appointee and overseen by political appointees? We can posit, and you do posit, an empowered public health-oriented FDA, but is that really realistic, I guess is the question.
Joshua Sharfstein: Sure, very fair question. And let me just say just one thing I just wanted to point out, that I think it’s important to say that if we want FDA, if we want naloxone over the counter, it’s not enough to say FDA has remove the requirement that there be a prescription. FDA is practically begging the company to make it over the counter. FDA needs to be able to actually initiate and create those over-the-counter conversions. And I think just taking away something but leaving the company’s objections in place accomplishes nothing. So an empowered FDA.
Now, I think it’s totally fair to say, “Okay, Josh, here you are arguing, let the FDA decide. Let it use public health criteria. Let it thoughtfully sort through the evidence. What could possibly go wrong. Tell me what you think could possibly wrong with that.” And I think you could imagine that the FDA is too risk-averse on putting things over the counter, and so you wind up without the benefits that could happen if certain drugs go over the counter. You could imagine the reverse. It’s a different FDA. The FDA puts too many things over the counter. So the FDA can make the wrong decisions.
Hopefully, with transparency and evaluation, you have a public process. You try to get that ship right. I do think that there’s a risk. And this risk exists, certainly for the FDA, it absolutely exists for companies too, of politics interceding. And I think the solution that’s maybe the common ground here is that we don’t think there should be political interference in the FDA’s scientific decision-making.
And I think I would agree with Michael on that, that there shouldn’t be that kind of political interference. They should have the space to make scientific decisions, to explain them fully to the public. There should be reviews of those decisions and kind of a process to figure out whether FDA is getting it right. That’s not a perfect process, but it’s by far a better process, I think, than deferring to companies with basically a weird mix of financial and liability incentives to make decisions and hope that that’s going to be in the public interest.
Ultimately, with Plan B, it was up to the FDA commissioner, who wanted to make a particular decision before she got overruled. And I think it’s important for certain decisions to be within the realm of the agency, just like any major scientific issue. But I just, I wish I had the magic wand that would make some of the politics go away on some of these very difficult issues. I’m not sure that just saying, “Well, we’ll get rid of the FDA’s ability to protect the public in this way,” is going to get you to that magic place. I think abortion politics will still be there on the other side.
Michael Cannon: This is an important point though, if I can jump in, Dan. We cite in the study, as far as we know, all of the economic literature that’s been compiled on, or conducted on whether giving government this power to require prescriptions makes patients less safe or more safe, whether the FDA is, as Josh is saying, protecting the public health. And all of those studies have pointed to the same conclusion, which is that giving the FDA this power does not protect the public health. The FDA is not, on balance, improving health when it’s making these decisions. It is actually resulting in worse health outcomes, rather than better.
Sam Peltzman is an economist who did a series of studies on enforcement for prescription regulations. He found that in the United States after the AFDA began imposing prescription requirements in 1938, poisoning mortality from drugs increased by 50 to 100 percent. He found that when you compare countries that do and don’t enforce prescriptions for antibiotics, there was no statistically significant difference in infectious disease mortality, so that, even when it comes to antibiotics, these regulations don’t seem to be helping.
And when he looked at, when he compared countries performance on drug poisoning for all drugs, and compared countries that do and don’t impose prescription requirements, he found that regulation — this is a quote from him, “Regulation did not reduce, indeed, may have increased poisoning mortality from drug consumption, because poisoning mortality is higher in countries that enforce these sorts of regulations.”
And so we should not start from a place where we are presuming that because we’re giving the FDA this power, the FDA is necessarily protecting the public. That’s not what’s happening here. The FDA is actually making the public less safe when it makes these decisions for us, because of some of the factors that we’ve already mentioned, but because of some other factors as well that Peltzman has identified, Peltzman and others. Peltzman found that before the FDA had this power in the decades leading up to 1938, when the FDA claimed this power, poisoning mortality had fallen by about two-thirds, poisoning from drugs, because private markets and the tort system were doing things to make drugs safer. So Peltzman said there wasn’t much room to improve.
Also, he notes that when the government requires people to consult a doctor before they make a medication decision, they end up making riskier medication decisions, not safer ones. An example of this is sometimes doctors just make bad recommendations. A couple of examples are the elixir sulfanilamide tragedy and the thalidomide tragedy. Ninety-five percent of the patients who died from taking elixir sulfanilamide in 1937 did it under the advice of a physician. They got a prescription.
In the case of thalidomide, 624 pregnant U.S. women took thalidomide, all of them under a physician’s direction, because it was not available over the counter. And Peltzman points to evidence that, in general, people make riskier drug decisions when the government is requiring them to sort of turn over part of their decision-making authority to a doctor, because they figure that the doctor is looking out for their interests, so they don’t have to.
And then another factor is another economist, Peter Temin makes the case that — and I think Daniel alluded to this earlier — when the FDA requires manufacturers to sell drugs on a prescription-only basis, it also required them to make sure that the labeling was incomprehensible to consumers, which left consumers ignorant about health and medicines and the nature of risk, which also jeopardizes consumers’ health.
And, finally, there have been — we cite another study in the paper that makes the case. Look, when governments all around the world are making these decisions to switch their drugs from, to switch drugs from prescription-only to over-the-counter status, they’re taking into consideration factors other than risk, factors like the financial self-interest of the manufacturers who lobby the regulatory bodies, or factors like the politics of reproductive rights.
When the entire rationale for giving the government this power is safety, and the fact that the governments base these decisions on factors other than safety, necessarily means that they are sacrificing patient safety, which just totally undermines the entire rationale for government-imposed prescription requirements. So I don’t think we should start from the presumption that Josh does, which is the FDA is protecting people. All of the evidence says that it’s not.
Dan Troy: So I’ll just mention that elixir sulfanilamide, the problem wasn’t that it was prescribed and whether it was a government doctor or not. The problem was that it had antifreeze in it, and that it was inherently, whether it was prescribed or not, it was toxic.
Josh, you had —
Michael Cannon: Right, but a prescription is not a guarantee of safety. And so — but anyway, I think it makes the point.
Dan Troy: That’s true, but in [overtalking 00:51:12]
Joshua Sharfstein: I think the challenge here is that we’re conflating a little bit these two issues. Should drugs be over the counter or not — this is where I started — and who should decide? And so the first question, should drugs be over the counter? Some of those studies you’re citing are really arguing things should really be over the counter. They’re not really arguing who is deciding. They’re saying things should be over the counter. And I don’t think it’s a credible position.
Michael Cannon: But they do compare regulation to no regulation. They’re not comparing over the counter to not over the counter. They’re comparing regulation to no regulation.
Joshua Sharfstein: Well, we could, we could go one at a time. But really, he’s looking, those arguments that you’re talking about are this is why people should have access to them over the counter. It’s fundamentally an argument for over-the-counter access. And I appreciate looking at 1938 before and after, and the number of poisonings in the early part of the 20th century. We have a very different pharmaceutical market. I don’t think it’s a credible position to say that we’re going to be safer if everything is over the counter. I’ll just say I don’t. And I’ll give you an —
Michael Cannon: — and no one’s arguing that.
Joshua Sharfstein: Well, I think that’s a little bit of the implicit assumption of some of those papers. I’ll give a specific example, or a specific point, which is on the idea of infectious disease mortality, where, basically, he’s not arguing about regulation, he’s arguing, should antibiotics be over the counter? His argument is antibiotics should be over the counter. There’s no difference in infectious disease mortality.
The problem with making antibiotics over the counter isn’t a question of whether or not there’s infectious disease mortality. It’s antibiotic resistance. It’s whether the drugs work at all. This is in your paper. Be careful about making antibiotics over the counter because of the potential of antibiotic resistance and suddenly they don’t work for anyone. And there’s a lot of evidence that over-the-counter antibiotics in other countries leads to a lot of antibiotic resistance.
And, so, in other words, there are critical public health considerations that make sense in deciding whether a medicine is over the counter or not. It would be the same for addictive medicines. It’s the same for medicines that people really don’t know how to use because of their complexity or they need very close medical follow-up to be able to use them safely.
So, on that first issue, core issue, I think that it’s very important for there to be the ability to impose a prescription requirement. Now, who decides that is the second question. And, here, we’ve kind of run around the table on this. But, at the end of the day, the companies aren’t making these, aren’t putting in for these drugs to be over the counter. If we want them over the counter, if we want to get the benefits of the ones where we would agree, you really need FDA to take a more active role.
Now I’m going to just end this part here by just bringing up your example of thalidomide. Now it is true that there were women in the United States who were given thalidomide by their doctor. It is also true that thalidomide was available over the counter in Europe, in Germany. And, tens — I think ten thousand plus babies suffered severe birth defects. That’s the kind of injury you can have if you’re not careful and you don’t have a public health agency looking out for the American people.
And the FDA never approved thalidomide, because there was a reviewer. And the fact that the medicine got into the country was through some loopholes in the research enterprise that were then closed by the amendments in 1962. I think thalidomide makes the case for a strong FDA protecting the public. And I would give it the ability to make smart decisions to advance the public health by making drugs more accessible. I think you and I agree there are certain drugs that could be made more accessible. But I think you’re going to have to recognize that just isn’t going to happen by letting companies make that decision alone.
Michael Cannon: If I can respond on the antibiotics, overuse of antibiotics is a real problem because antibiotic resistance is a real thing. The question is, does regulation, does having the government require a prescription for antibiotics improve on the situation? And all the evidence we have right now says no, it does not. And so —
Dan Troy: — I’m not sure I understand that. Isn’t this — and I’m not an economist, but a good example of market failure where individual companies have the incentive to sell as much as possible, right, because they make more money. But if they do that, then there is this sort of — I don’t know whether — this effect where, overall, it makes these products less effective and then harms the public health. Is that a place the government should step in?
Michael Cannon: It’s a classic negative externality where you might want the government to step in. Because my decision to take an antibiotic has an effect on you, and therefore you don’t want me to overuse antibiotics because that might lead to antibiotic-resistant bacteria. And that’s then going to harm your health. It’s very similar to the debate over vaccines. But the relevant question for policy-makers is not is antibiotic resistance a real thing, or even, does overuse lead to antibiotic resistance? It is does this particular government intervention solve the externality problem?
Dan Troy: What would —
Michael Cannon: — Does this intervention prevent that — does this intervention prevent that externality? What Peltzman’s study suggests is, no, it does not. And the advocates of prescription requirements for — well, government-imposed prescription requirements in general, and with regard to antibiotics in particular, just assume that it works. They say, well, in theory, there’s a plausible theory that it could help. So we’re going to go ahead and impose these requirements. They don’t offer any cost-benefit analysis. They don’t offer any empirical data showing that it will work. They just say, “We think it does,” or “We think it will.”
And then when someone actually conducts the study that says, “You know what? It’s not solving the problem that you think it should,” they just revert to theory and disregard the evidence. And that is really the — I think that’s the wrong way to approach these questions. If what you want to do is protect public health, you should be able to demonstrate that you are doing that. And if these interventions don’t demonstrate public health benefits, or worse, if there’s evidence of harm, which is what Peltzman has identified, then we should take a hard look at all of these interventions and —
Joshua Sharfstein: I didn’t read his study to be about antimicrobial resistance, at least as you cited it. And antimicrobial resistance is much more of a problem, as I understand it, in low- and middle-income countries that have much less strict prescription requirements. And you can think about some medicines that really have to be restricted in order to not develop resistance. And hoping that that just works out on the open market, I think is not a great strategy for the health of all of us.
And, in the end, I think that — I totally appreciate the approach of saying, look, there are different ways of selling drugs that could make us all healthier. I am all in on that. That’s where we, I think, do actually have some common ground. I think for — we have a difference on how to get there. And I think that I believe in an agency that is responsible to the public for its health to be helping with that. And I do think that solely relying on companies isn’t actually going to make progress in the very direction that you want to go, Michael.
Dan Troy: Okay. Well, I think that’s a great note on which to leave it right there, if that’s okay with you, Michael. I think this has been a really good discussion. I’m sorry we didn’t really get to Q&A’s. I’ve been checking the Q’s, and I think we’ve covered a lot of the areas that were articulated in some of the questions.
And I can’t thank you both enough for your participation in this, again, for focusing on some areas of agreement and also sharpening some areas of disagreement. All I can say is, read Michael’s paper. It’s really good. And will challenge you in ways that you probably were not challenged. I certainly had not really even focused on this. So read Michael’s paper. And thank you so much to Josh and to Michael for this discussion.
Jack, anything you want to say in summation?
Jack Derwin: I would just echo you, Dan, and thank all three of you for joining us today. I thought it was a fascinating discussion. And thanks to our audience for tuning in to today’s virtual event. You can check out our website at RegProject.org, or follow on any major social media platform at FedSocRTP to stay up to date. And, with that, we are adjourned. Thank you.
Dan Troy: Thanks everyone.
Michael Cannon: Thanks.
Joshua Sharfstein: Thanks. Bye.
Director of Health Policy Studies
Vice Dean for Public Health Practice and Community Engagement
Bloomberg School of Public Health, Johns Hopkins University
Chief Business Officer, Chief Administrative Officer, and General Counsel