Dr. Jeff Singer on Prescription Drug Freedom
2020-11-21 · Guest: Dr. Jeff Singer (Senior Fellow at the Cato Institute) · 52:25
Ending Government Power to Require Drug Prescriptions
Bob Zadek and Dr. Jeff Singer discuss the history and consequences of the US prescription drug system, tracing its origins from a voluntary recommendation to a government-mandated restriction. They argue for a “Drug Reformation” to end the FDA’s power to require prescriptions, highlighting how current policies undermine patient autonomy, increase drug prices, and allow political interference in medical decisions.
Topics: Prescription Drugs, FDA, Drug Reformation, Cato Institute, Durham-Humphrey Amendment, Plan B, Drug Prices, Healthcare Policy, Patient Autonomy
Speakers:
- Bob Zadek: Host
- Dr. Jeff Singer: Senior Fellow at the Cato Institute
Introduction and the COVID-19 Test Prescription [00:00]
Bob Zadek: Hello everyone, welcome to The Bob Zadek Show, the longest-running live libertarian talk radio show in all of radio. Thank you so much for listening this Sunday morning. Well, with us being inundated day and night by the health crisis—the claimed health crisis caused by COVID-19, of course—with us being inundated daily with new cases and with deaths and with hospitalizations, with us being inundated by claims, true or not, about the politicalization of the preparation, manufacture, and sale of a vaccine, with us being inundated about the politicalization of the lockdown.
In other words, all of our news these days is crowded out by medical/economic information. The economic information is a direct result of the medical situation we are living in. All of a sudden, us Americans are paying a lot more attention to the whole process of manufacture, distribution, sale, pricing of prescription and non-prescription drugs. What a perfect time for this morning’s guest, Dr. Jeffrey Singer, to have published an important paper over at Cato. Jeffrey and his co-author, Michael Cannon, also at Cato, introduce us all to the not-so-complex but fascinating history of prescription drug availability, sale, and use in America. And what a fascinating history it is.
It occurred to me that all of us, most of us, probably all of us use prescription drugs. We buy them, we acquire them from our pharmacies and the like. We acquire over-the-counter drugs from our pharmacies and from our supermarkets. But probably none of us have given much thought to the whole concept of prescription drugs and the use of prescriptions. When you think about it, as you will during this hour, prescription drugs are just another aspect of the permission-full society we live in, where so much of the operation of our daily lives requires the permission of a government official. It’s been around for so long we sort of take it for granted. But should we be required to seek permission from anybody to put something into our body? That is this morning’s question. I dare say many of you will change your opinion about an hour from now. To help us understand this fascinating, complex subject of prescription drug use in America, I’m happy to welcome back to the show Dr. Jeffrey Singer. Jeffrey writes over at Cato. He is a senior fellow at Cato and he works in the Department of Health Policy Studies. And as I said, he has just published with Michael Cannon, Drug Reformation: End Government’s Power to Require Prescriptions. Jeff, thank you very much for joining us this morning.
Dr. Jeff Singer: Oh, it’s a pleasure to be here. And you know, as you were mentioning the COVID-19 pandemic, it just came to my mind a perfect sort of lead-in, a setup for what we want to talk about today. As many of your listeners probably know, just a few days ago, the FDA gave emergency use authorization for the first-ever at-home self-administered test for COVID. But they said that you can’t get it without a prescription, and a doctor is not to prescribe it for you unless you have symptoms. So here’s this thing where you could finally take it at home without going to a doctor’s office and risk contaminating other people or getting contaminated. But in order to get it at home, you’ve got to get a permission slip from a doctor, and he’s not allowed to grant you permission unless you’re symptomatic. And then on top of that, we just hear even recently that the reason why this pandemic is so difficult to control is because about 40 to 50% of people have no symptoms and they’re spreading it around unknowingly. And here’s an opportunity for people who are conscious of that fact to test themselves to see if, even though they have no symptoms, do they have COVID? But they’re not allowed to because they have to get a permission slip and they have to have symptoms to get the permission slip. So this is a perfect lead-in to what we want to talk about today.
Bob Zadek: Now Jeff, without getting sidetracked onto COVID, but you piqued my curiosity. What is the rationale, if there is one, behind requiring a prescription to do something as benign as testing to see if you have COVID-19? Since the FDA is designed, one would think, to protect us from doing bad things to our body, how could testing for COVID-19 be a bad thing and therefore what’s the reason for the prescription?
Dr. Jeff Singer: I have no idea. There’s no prescription required for the at-home pregnancy test or an at-home HIV test. But for an at-home COVID test, it’s designed for at-home use. And in fact, the FDA’s memo actually stated that when you get the prescription from a doctor, you could still do it yourself. The doctor is not necessary to provide the test on you. So then why get permission? That’s just, you know, one example of how the government is standing in the way of us being able to take care of ourselves, make our own decisions about testing ourselves and medicating ourselves. So that’s just the most recent and most timely example of what we go into in great detail in our white paper, Drug Reformation.
The History of the Prescription Requirement [03:55]
Bob Zadek: Now Jeff, most of the people, probably everybody listening to the show, has been born into a system of prescriptions as a requirement for us to buy and to administer to ourselves certain drugs. But in the history of our country, prescriptions are relatively new. So tell us briefly, when did the reliance upon prescriptions as governing who can buy what medication, when did all of this start and for what reason?
Dr. Jeff Singer: Yeah, actually this started in 1951. Prior to that time, it was widely recognized that every human being has the right to self-medicate. And the right to self-medicate is sort of a corollary of the right to informed consent. So for example, you can’t perform a procedure on me or make me take a medicine without my informed consent, even if I’m making a terrible decision not listening to you. It’s understood by everyone that you have to respect my decision either way. A corollary of that is if I want to medicate myself or perform a test on myself, I shouldn’t need your consent for me to do that. That’s just as well my right.
And in fact, back in colonial times, Thomas Jefferson was speaking to a group about freedom of speech. And he, to explain that point, said freedom of speech is so sacred, it’s as sacred as the right to self-medicate. So this was kind of considered in those days so self-evident that he was using that as an example of how important the right to free speech is. And now we’ve come completely 180 degrees. So nowadays I have to explain to people that the right to self-medicate is as sacred as the right to free speech.
So what happened was up until the 1950s, if you—even though evidence shows that the overwhelming majority of people who took medications sought the advice of an expert like a doctor. But pharmacists are also experts. And people would go into a pharmacy and they oftentimes would consult the pharmacist and ask what the pharmacist recommends, but they would ultimately at the end of the day make their own decision. They may have carried with them a prescription from their doctor, which was the doctor’s recommendation. And sometimes the pharmacist would look at the prescription and say, “Well, could I suggest something else?” and make the case for it, and the individual would at the end of the day make the decision. So this prescription wasn’t a permission slip; it was a recommendation.
The Sulfanilamide Disaster and the 1938 Act [06:41]
Dr. Jeff Singer: And this was going on fine. And then in 1938, there was a huge catastrophe occurred. It was called the sulfanilamide scandal. So sulfanilamide, a sulfa drug, was the first ever antibiotic ever invented. And it was a miracle because people were dying of infectious diseases so often. And in 1938, the company Massengill developed an oral elixir form so that people who couldn’t take pills or children could then take it because it was an elixir. And unfortunately, the chemist who developed it used as the solvent for the sulfanilamide diethylene glycol, which is chemically related to ethylene glycol or antifreeze, and it was poisonous. So there were 105 deaths due to taking sulfanilamide, and 34 of them were in children.
And of course, this was terrible. And this led to the Congress passing the Food, Drug, and Cosmetic Act of 1938. Up until then, the only act in effect was the Pure Food and Drug Act of 1906, which basically created what became the Food and Drug Administration. And they were just basically—it was almost like a truth-in-advertising act. Any product that was sold was tested to make sure it’s what it said it was and didn’t have any adulterants or intoxicants that could hurt people, that it was whatever the manufacturer said was in there was in there. That’s all that the FDA was dealing with at that time.
But after 1938, the Food, Drug, and Cosmetic Act said that from this point forward, any new product that any manufacturer wants to bring to market has to go through a testing process until we’re persuaded that it’s safe to be sold to the public. And anything currently in use is exempted from this. So by that time, aspirin was exempt, insulin was exempt because that was around since around the time of World War I. And that’s why to this day there are a couple of types of insulin you can get over the counter in the United States. And but that from that point forward you had to persuade the FDA that it was safe or they won’t let you market it.
And if you marketed it, if the manufacturer decided that they wanted to market it over the counter, they had to make the labeling clear enough that a person with a very rudimentary education could understand it. The FDA had to approve the labeling. If they had chosen to make it by prescription only, which was a decision of the manufacturer, then they wouldn’t have to satisfy the labeling requirements because that would become the responsibility of the prescriber. And even before 1938, there were manufacturers deciding as a proprietary decision that we want to make this available by prescription only because we think this somebody might be able to use it the wrong way and hurt themselves and we don’t want the liability. And so they would supply the pharmacies under the stipulation that the pharmacies couldn’t sell that product to someone without a prescription. That was already a private sector decision.
The Durham-Humphrey Amendment of 1951 [09:30]
Bob Zadek: Jeff, let me just interrupt to bring the audience up to date with where you are in your story. In 1951, the change was profound. Up until 1951, the decision upon what drugs you could take was between you and your physician as to whether your physician would write a prescription. The manufacturers could require prescriptions if they want, but basically the decision was to a considerable extent yours and perhaps your physician’s. After 1951, a profound change happened and that basic decision about medication was taken from the physician and the patient to the government. Is that a fair summary of where we are so far?
Dr. Jeff Singer: Yeah, actually to be more precise, the decision was always the patient’s. The patients would consult their physicians most commonly, but even if the physician wrote a prescription, the patient sometimes could get another opinion from, let’s say, the pharmacist. And then at the end of the day, the patient would decide what to take, not the physician. But overwhelming majority of time, and this is reasonable, people would want the advice of a person who’s an expert and they would consult the physician.
So now that decision now, a substantial portion of decision-making as to what drugs you could take on your own decision was removed and was placed in the hands of the FDA and the government in general. So that’s post-1951. And that changed everything because that suddenly, as I’m sure a lot of your listeners are very acutely aware of, that changed the decision from being one not only of—it stopped respecting of course the autonomy of the individual patient, but it also made all decisions going forward subject to politics. Because now you have all different special interest groups and you have political concerns that influence whether the Food and Drug Administration is going to make something that is currently prescription-only over the counter and vice versa.
Safety, Autonomy, and the Knowledge Problem [12:05]
Dr. Jeff Singer: It also, we point out in our paper, that contrary to what people think, it actually didn’t increase safety. Sam Peltzman, who did a lot as an economist at University of Chicago, did a lot of work on this, actually showed empirically that since that requirement went into effect, the percentage of drug poisonings, you know, poor drug reactions, that kind of thing, actually increased relative then to the time before the prescription requirement was put in place by the FDA. And there are a lot of different reasons for it.
Bear in mind that when—and as an example, when the sulfanilamide disaster occurred, out of those 105 deaths, 95% of people who died from the sulfanilamide were taking it at the doctor’s recommendation. And if you look through the records, and we provide a lot of this in our paper, there were people who were calling the doctor and saying, “You know, my little girl’s getting sicker and sicker,” and the doctor would say, “Okay, then give more sulfanilamide elixir, double up on it.” So they were following the advice of their doctor. These were not people who were doing something reckless to themselves.
And there’s a lot of empirical evidence which we go into in our paper that people tend to be much more willing to trust the expert when they get a prescription drug than when they go over the counter. When you go over the counter, you do a lot more due diligence. You start asking a lot of questions, you comparison shop, you go up and ask the pharmacist some things, you may go online and do some research. Whereas there’s a tendency when a doctor prescribes it just to kind of assume, “Well, he’s the expert, I’ll just do what he says.”
I can tell you as a practicing physician, I see this often when I take a history on my patients and I’m trying to get their medication history. And they’ll say, “So what medications you take?” and they’ll say, “Well, I take a blue pill and a black and white striped pill and a red pill.” And what are they for? “I don’t know, I think one of them is for blood pressure and one of them is for cholesterol.” Those are the kind of things you’ll often get from patients and they don’t know what it is, they just know what to do because they’re following doctor’s orders.
On the other hand, if they’re going to medicate themselves, they know everything about it. And in fact, birth control pills, here’s another good example. In over 100 countries in this world, you can get them over the counter. In the United States, the American College of Obstetrics and Gynecology has for at least the last 15 years officially encouraged the FDA to make birth control pills available over the counter. And so has the American Academy of Family Practice. Now that means something because if the American Academy of OB-GYN has—they’re actually taking an economic hit. They’re saying you don’t need to come to me and pay me $150 so I can give you a prescription for birth control pill, you should be able to go get it yourself. And so they’re giving up money. So that means something for them to say that.
But despite that, it’s still prescription-only in this country. And at University of Washington in Seattle in 2006, there was a really interesting study done where they asked women to basically self-screen. They gave them a questionnaire and they asked them to determine based upon the questionnaire whether they think they are a good candidate for oral contraception because, you know, there are certain contraindications like if you’re a smoker it’s more dangerous, you can get a blood clot, and there are other things. So what they found was that the women who self-screened were in agreement with professional OB-GYN doctors 90% of the time. The 10% of the time that they weren’t in agreement is because the doctors were actually more liberal about it. The doctors thought they could take it and the women thought they shouldn’t take it. And of course that could mean one of two things. It could mean either that the doctors were reckless or that the women were overly cautious. We don’t know actually for sure. But the point is that that’s just another illustration of the fact that people tend to be actually much more involved and engaged when they’re making the decisions and there’s a tendency for them to surrender judgment and even in some cases even knowing what the medications are when it’s prescribed by someone.
And I’ll be the first to admit, doctors make mistakes. I can’t tell you—I’ll tell you honestly, for example, and I would argue that there’s not a single doctor who will deny this. I’ve as a surgeon, I’ve written a prescription here and there for a patient, let’s say an antibiotic for an infection, and then I get a phone call from the pharmacist saying he notices that I wrote a prescription for this infection and this patient is taking a certain drug, let’s say an anti-anxiety medication. And I say, “Yeah, I’m aware of that.” And the pharmacist will say, “Well, I don’t know if you’re aware, but that particular antibiotic has a terrible interaction with that anti-anxiety agent, so I really don’t recommend that you prescribe that.” And I’ll say, “You know, I wasn’t aware of that at all. Oh, thank you for letting me know.” Because obviously pharmacists are trained professionals who know more about this stuff usually than we doctors do. And then the pharmacists would say, “So what kind of infection are you treating because I could recommend some antibiotics that won’t have that interaction?” And then of course after discussion with the pharmacist, I’ll change the prescription. So there’s a perfect example. This happens all the time. Just because it’s prescribed by a doctor doesn’t necessarily mean it’s foolproof. There are, you know, we doctors don’t know every single thing, which is why there are different, you know, there’s a division of labor, there are different specialists, and pharmacists are very specialized in these kind of things. But so just because it’s a prescription-only doesn’t guarantee safety, and there’s empirical evidence that it probably makes you less safe.
The Politicalization of Plan B [15:05]
Bob Zadek: Jeff, your paper is entitled Drug Reformation. So you have described the existing system, full of politics, full of non-medical considerations. So in your paper, what is the reformation you call for and what would be the economic and the medical benefits and detriments, if there are any, to drug reformation? What is the headline of what you’re calling for in your paper and then share with us the economic and medical benefits?
Dr. Jeff Singer: Okay, well in our paper also we go into other areas that need to be reformed as well. But if we stay focused on the prescription requirement, what we argue is that ending the prescription requirement, number one, most importantly, respects patient autonomy and the right to self-medicate. Number two, likely increases patient safety. Number three, will likely lead to reduced drug prices. There’s a large amount of empirical evidence that when drugs move from prescription-only to over-the-counter, the prices drop, sometimes dramatically. And so we argue and we can get into that in a minute if you want, but we argue that we need to end the prescription requirement.
And then when people say, “Well, what would happen if the FDA gets out of that business?” Well, actually you’re not going to see a lot of changes because since 1951, there are a lot more complex drugs and the—there’s a really good likelihood that in many of these drugs, the pharmaceutical manufacturers are going to still require that the pharmacist dispense them only with a prescription because they’re going to have not only reputation concerns but they have liability concerns. But on the margin, a lot of the routine everyday drugs that can be moved to over-the-counter will get moved to over-the-counter, especially due to market forces and competition, and that will save people a lot of money. And so you won’t—and in addition to that, you’re going to probably have more patient engagement in their self-medication.
Also, there’s a lot of room for innovation. So for example, it doesn’t have to be binary: prescription or over-the-counter. In many of the other countries, there’s a third category, which is pharmacist-only or behind-the-counter. So for example, there are some countries like in England, you can get a statin drug behind the counter. So that means that you can’t just take it off the shelf with a box of razor blades and Band-Aids and go to the checkout counter; you’ve got to ask the pharmacist for it. And the pharmacist has an opportunity to ask you some questions before he decides to sell it to you to decide whether or not he thinks you know what you’re doing, and a pharmacist has a right to say, “I don’t want to sell it to you.” So that’s another option, for example, that pharmaceutical manufacturers will have at their disposal if we get rid of the Durham-Humphrey Amendment because they could say, “Well, this isn’t quite tricky enough where we want it to be prescription-only, but we’d like some person to be a buffer who knows about this stuff, so we’re going to say it can only be dispensed behind the counter by the pharmacist.” That’s another option.
When these things are over-the-counter, there’s so many more innovations that can come available. For example, if birth control pills were over-the-counter or naloxone was over-the-counter, you don’t just have to go to a pharmacy for over-the-counter drugs; you could get them at convenience stores, at the checkout counter in supermarkets, maybe in vending machines. They already are making Plan B available in vending machines in many places in college campuses. And by the way, there are companies now that have kiosks where you can do all your pharmacy out of a vending machine. That’s already in existence. So there’s so much room for innovation, but right now the FDA is standing in the way.
International Comparisons and the Case for OTC Insulin [18:30]
Bob Zadek: You mentioned economics. Tell us a bit about the drug manufacturers. That’s the starting point because they can designate—they have some say in whether a new drug is prescription-only or over-the-counter, but they don’t have ultimate control. The government has the ultimate control. So what are the economics? And you mentioned lower costs, but tell us a bit more about how that works through the system to produce lower prices to consumers.
Dr. Jeff Singer: Okay, there are three ways in which a drug can be converted today under today’s law from prescription-only to over-the-counter. One is if the manufacturer petitions that the FDA reconsider it. Two is if any interested person petitions. And three, the commissioner could just decide to make it over-the-counter. And oh, then the fourth way of course is Congress could pass a law saying it’s over-the-counter.
So generally speaking for the last 20-30 years, the FDA has—and this is probably due to a certain amount of regulatory capture—they have deferred to the manufacturer regardless of what individual groups have petitioned for. And what we’ve seen is that because health insurance generally doesn’t cover prescription drugs but only over-the-counter drugs—no, you have it backwards. I think you have it backwards. Health insurance covers prescription but not over-the-counter. Oh, okay, that’s what I said, but thank you for correcting me. So yeah, so that gives the manufacturers a great opportunity to sort of game the system. And I could tell you because as a doctor we do this too and so do hospitals. So you got this deep-pocketed third-party payer, the insurance company or Medicare or Medicaid or whatever, and the drug company charges a very high price, much higher than any individual would be willing to pay. And then of course it gets negotiated down to a lower price and they’re still doing quite well.
So there’s been a tendency of late for the drug manufacturers not to want to make it over-the-counter. So an excellent example of this is antihistamines. And this is also an example how prescription requirement doesn’t necessarily mean it’s safer. So the over-the-counter antihistamines were very sedating, like Benadryl, for example. They’re so sedating that the FAA wouldn’t allow a pilot to fly a commercial airplane under the influence of Benadryl. In 1993, Schering-Plough came out with the first non-sedating antihistamine, Claritin. Shortly thereafter, Zyrtec and Allegra came out, same thing, non-sedating antihistamines. These were prescription-only. So you had this situation where the safe non-sedating antihistamines you needed a prescription for, but the more dangerous over-the-counter sedating antihistamines you didn’t need a prescription for.
Meanwhile, Schering-Plough was lobbying the regulators in Europe to make Claritin over-the-counter. And it was, so it was over-the-counter in Europe but was prescription-only in the United States. In the late 90s, some health insurance plans petitioned because any interested person, they petitioned the FDA to make it over-the-counter because they were spending a fortune on paying out for prescription non-sedating antihistamines and they wanted this over-the-counter. Schering-Plough actually protested and lobbied against and lobbied successfully against making it over-the-counter, arguing it’s not safe. So at the same time they’re arguing to European regulators that this is safe and should be over-the-counter, they’re arguing to the FDA that it’s not safe and should be prescription-only. Why? Because they were making a ton of money on this, as were the makers of Zyrtec and Allegra. Finally in 2002, Schering-Plough came out with a new prescription non-sedating antihistamine and they started thinking with this pressure to make Claritin over-the-counter, now’s a good time to say to the FDA, “Yeah, we’d like you to make it over-the-counter,” because its name ID was so good that it’ll compete very, very effectively against the sedating antihistamines and we can make a ton of money on both the prescription line with our new product about to come out and on the OTC line with Claritin. So in 2002, Claritin became over-the-counter. In 2007, Zyrtec became over-the-counter and in 2011, Allegra became over-the-counter. But there’s a perfect example of it has nothing to do with safety. In fact, the dangerous drugs were over-the-counter and the safe drugs were prescription-only, but there were financial incentives to the pharmaceutical companies to keeping it over-the-counter.
The same thing’s happens with naloxone. The FDA for the last few years has practically been begging the makers of naloxone, the opioid overdose antidote, particularly Narcan, which is a nasal spray, they’ve been begging them to make it over-the-counter. They said, “This has been around since the 70s, it’s safe to use by non-professionals, if you don’t need it, nothing will happen if you take it, we recommend, we ask the manufacturers to ask us to make it over-the-counter.” And they’re not asking. And then they reached the point where about a year ago, Commissioner Scott Gottlieb at the time said, “We don’t usually do this, but we’re already taking the trouble of filling out the application for you and we’ve pre-approved the labeling that an over-the-counter version of your naloxone would require, and that’s usually your job, not our job. All you need to do basically is sign on the dotted line and we’ll go ahead and get the process moving,” and they won’t do it.
And then in October of 2019, I was a participant with another colleague, David Hyman, who’s an adjunct at the Cato Institute, at a Capitol Hill briefing in Washington where we were explaining to Capitol Hill staffers why Congress should just pass a law making naloxone over-the-counter. And we talk about this in our paper, the sales rep, the lobbyists, the sales representatives for the makers of naloxone were trying to contact us before the meeting and they cornered me after the meeting trying to make the argument, “Oh no, you don’t understand, it’s actually cheaper for the people if it’s prescription-only.” And I said, “I’m really curious to know how you could say that.” “Well, it’s $145 for two Narcan nasal spray packets, but you only have a $10 co-pay when you pay for it with your insurance, whereas otherwise it would be $145.” And of course my response was, “The people using, you know, IV heroin on the streets don’t usually have their insurance cards with them, okay?” And so that’s really not a big sales feature to them. But of course this is where they were coming from.
So by taking the government out of this and taking politics out of this, then we allow market competition to enter the fray. I mean, there’s a whole lot of other reforms. This isn’t the panacea. And in our paper, we actually spend a lot of time talking about other aspects of the regulatory system that need a reform, seriously need reform. But this is an important one and it’s an important place to start and it’ll go a long way towards improving affordability and safety.
Economic Consequences and Third-Party Payers [21:00]
Dr. Jeff Singer: In also in our paper, Michael Cannon discovered this by getting data from the Bureau of Labor Statistics. Here’s an example again how prescription versus over-the-counter and third-party payers plays a role. So even though birth control pills are prescription-only, up until the Affordable Care Act was passed, most health insurance policies would not cover birth control pills. So women would have to pay for it out of pocket. And if you look at the data up until about 2011 when the ACA officially went into effect—or rather was passed—the prices of birth control pills were actually trending down and following the same trend line of over-the-counter medications. And prescription pill prices were also prescription drug prices were also slowly trending down but not as rapidly as birth control pills and over-the-counter drugs. Then when the ACA went into effect in 2014 and insurance companies were required to pay for birth control pills and there was supposed to be no out-of-pocket expense to the purchase of birth control pills, not only did prescription drug prices start going up, but birth control pills prices started going up and they skyrocketed. Actually they went up at a rate three times the rate of prescription medicines going up, while over-the-counter medicines only went up slightly since 2014 in price. So what happened was as the cost and the feedback loop of people purchasing birth control pills disappeared, cost was no longer an issue to the consumer and the insurance companies were picking up the tab. Number one, the purchasers of it didn’t really care how much it cost, and number two, the manufacturers started overcharging because they could to a third party. And of course not everybody has health insurance and there are a lot of women, particularly low-income women, who now are priced out of the market for purchasing out of their own pocket birth control pills because of the way the price has gone up.
Bob Zadek: And what’s interesting is of course, even though one can say listening to your narrative that, well, the insurance companies picked it up, but duh, the insurance companies are determined to make a profit. Therefore, the premiums go up proportionately, which means of course consumers ultimately pay, but they pay in the increased cost a bit of their medical insurance, which means society bears the entire cost of subsidizing the people who actually use the medication, the prescription, the now birth control. So to say it’s like the cost of the drug are now free, of course they’re not free, Jeff, as you know, but I want to be sure the listeners understood that. That government has long since discovered that if they can pass a cost along to business to bury in the price of the product, in this case premiums, consumers don’t know that government has increased the cost because it is buried like sales tax. So nobody is particularly fooled.
The Efficacy Requirement and Drug Innovation [23:30]
Bob Zadek: Now Jeff, we only have a few minutes and I’m hopeful in a couple of minutes you can explain another point in your paper about the FDA’s role in determining the effectiveness of the drug. It’s a big topic, Jeff, we only have a minute or so, but should they be involved at all in determining whether a drug works? And tell us in about a minute, Jeff, how silly it is because once a drug is approved for one use, it’s approved for any use anybody wants.
Dr. Jeff Singer: Yeah, I’ll have to be real quick, but that basically is result of the Kefauver-Harris Amendments to the FDA Act that was in 1962. There was a drug that was not yet approved by the FDA, thalidomide, which was being given out to women, prescribed by doctors without them telling them it was experimental, for pregnancy nausea of pregnancy. And it caused terrible birth defects. So Congress swung into action, they said, “Okay, from this point forward, not only are we tightening up the safety requirements, but we’re now going to require that you prove that the drug works, that it has efficacy.” Now what that has to do with giving a non-approved drug to people that cause birth defects, efficacy—it was very efficacious, it really worked well to prevent morning sickness. But so I don’t understand how they got to that spot.
But all doctors do and in medical science does, if you look at medical journals and go to medical meetings, that’s all we do is talk about efficacy, the efficacy of this drug versus that drug for the treatment of whatever. So by the FDA requiring these trials, these clinical trials that we’re hearing about now for example with drugs for COVID, it takes on average now 12 years and about $500 billion to bring a drug to market. And once it is approved as having efficacy for let’s say condition A, because when you file out your new drug application you have to tell the FDA what you want it to be used for, so once the FDA says it is approved for use for condition A, as far as the FDA is concerned, they trust clinicians to use their knowledge of the research and the clinical data they’ve seen to prescribe it for anything else, condition B through Z. So they determine based upon what they think is the efficacy. So of course it begs the question, if I had to why did I have to wait 12 years for you to tell me I can prescribe it for condition A when once you tell me that you don’t care if I prescribe it for B through Z because you trust my judgment? Why didn’t you just trust my judgment in the first place?
Bob Zadek: Jeff, I need to interrupt to give one final reminder to our listeners. Jeff’s paper, his white paper, is Drug Reformation: End Government’s Power to Require Prescriptions. It’s available at cato.org. It is interactive, you will enjoy reading it, you will learn a ton, and you will rethink your entire position on how much you need prescriptions to protect you from yourself. Jeff, thank you so much for the work on the paper. Thanks to our friend Michael Cannon as well, and thanks for your contribution this morning, Jeff. Have a good rest of the weekend.
Dr. Jeff Singer: Thank you, you too. It’s at cato.org/drugreformation. Thank you.
Bob Zadek: Thanks a lot, Jeff, and thanks to our friends out there for giving us an hour of your time.