Dr. Jeff Singer on a Prescription Drug Reformation
The “Doctor for Liberty” explains how special interests raise drug prices and undermine the right to self-medicate
“Government‐imposed prescription requirements violate the rights of individuals to access the medicines they want.” — Dr. Jeffrey Singer and Michael F. Cannon
The libertarian argument for the right of bodily autonomy is simple:
We own our bodies. Therefore, we should have the right to put whatever we choose into them.
Until the 20th century, this was taken for granted. But as Singer and Cannon lay out in their expansive new white paper on ending government’s power to require prescriptions, this right has been gradually eroded.
The result is a more dangerous world, where consumers rely on untrustworthy institutions that restrict their choice and bypass more secure market mechanisms for determining safety and efficacy. Prescription drug companies rake in profits from their privileged legal status, and consumers suffer.
Drug Reformation: End Government’s Power to Require Prescriptions | Cato Institute
How did we get here? Tune in, as Jeff “@Dr4Liberty “ Singer returns to the show to break down his recommendations for reforming a broken system.
Transcript
Bob Zadek: Welcome to the Bob Zadek show, the longest running live libertarian talk radio show in all of radio.
We are inundated day and night with new cases, deaths and hospitalizations, related to this “health crisis,” caused by COVID-19, of course. We are inundated with claims about the politicalization of the preparation, manufacture and sale of a vaccine. All of our news these days is crowded out by medical and economic information as a direct result of the medical situation we are living in.
All of a sudden, Americans are paying a lot more attention to the whole process of manufacturer, distribution, sale, and pricing of prescription and non-prescription drugs. What a perfect time for this morning’s guest, Jeff Dr. Jeffrey Singer, to have published an important paper over at Cato.
Jeffrey and his co-author Michael, Michael Cannon, 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 use prescription drugs. We acquire them from our pharmacies and we acquire over the counter drugs from our pharmacies and from our supermarkets. Most likely 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. Should we be required to seek permission from anybody to put something into our body?
That is this morning’s question. I’m happy to welcome back to the show. Dr. Jeffrey Singer. Jeffrey writes over at Cato, he is a senior fellow there and he works at the department of Health Policy Studies. 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.
Jeff Singer: It is a pleasure to be here. As you were mentioning the COVID-19 pandemic, it just came to my mind that a perfect lead for what we want to talk about today is the FDA’s emergency use authorization for the first ever at-home self-administered test for COVID. However, they said that you can’t get it without a prescription. A doctor is not to prescribe it for you unless you have symptoms. In order to get it at home, you have to get a permission slip from a doctor and he’s not allowed to grant you permission unless you’re symptomatic.
On top of that, we just recently heard 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 unknowingly. 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 their permission.
Bob Zadek: 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 to protect us from doing bad things to our body, how could testing for COVID-19 be a bad thing?
Jeff Singer: I have no idea. There’s no prescription required for the at home pregnancy test, or an at home HIV test. The FDA memo states that when you get the prescription from the doctor, you can still do it yourself. A doctor is not necessary to provide the test on you. So then why get permission? That is just 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.
That’s just the most recent example of what we go into in great detail in our recent paper.
The Rise of Prescription Drugs: A Loss of the Right to Self-Medicate
Bob Zadek: 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. However, in the history of our country, prescriptions are relatively new. Tell us briefly, when did the reliance upon prescriptions as governing who can buy what medication? When did all of this start?
Jeff Singer: The requirement started in 1961. Prior to that time, it was widely recognized that every human being has the right to self-medicate. 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 and not listening to you. It’s understood by everyone that you have to respect my decision. A corollary of that is, if I want to medicate myself or perform a test on myself, I shouldn’t need your consent from you to do that. That is just as well my right.
In colonial times, Thomas Jefferson was speaking to a group about freedom of speech. He said, freedom of speech is so sacred that it is as sacred as the right to self medicate. So this was considered in those days so self-evident that he was using that as an example of how important the right to free speech is. Now we’ve come completely 180 degrees.
Today I have to explain to people that the right to self-medicate is as sacred as the right to free speech. 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 consult the pharmacist and ask what the pharmacist recommends, but ultimately, at the end of the day, they would make their own decision.
“Thomas Jefferson was speaking to a group about freedom of speech and said, ‘freedom of speech is as sacred as the right to self medicate.’ In those days, this was considered self-evident.”
They may have carried with them a prescription from their doctor, which was the doctor’s recommendation. Sometimes the pharmacist will look at the prescription and 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. And this was going along fine.
Then in 1938, there was a huge catastrophe called the sulfanilamide scandal. So sulfanilamide 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 oil elixir form so that people who couldn’t take pills, like children, could take it because it was elixir.
Unfortunately, the chemist 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 were children. This was terrible. 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 Drug Act of 1906, which basically created what became the Food and Drug Administration. They were just basically making sure that any product that was sold was tested to make sure it is what it said it was and didn’t have any adulterants or intoxicants that could hurt people. 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 so we are persuaded that it’s safe to be sold to the public.
Anything currently in use is exempted from this. By that time, aspirin was exempt. Insulin was exempt, because that was around since around the time of World War I. That is why there are a couple of types of insulin you can get over the counter in the United States. If you market it, and if the manufacturer decided that they wanted to make a market 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 approved 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 labeling requirements because that would become the responsibility of the prescriber.
Even before 1938, there were manufacturers deciding as a proprietary decision that we want to make this available by prescription only because we think that somebody might be able to use it the wrong way and hurt themselves and we don’t want the liability. They would supply the pharmacies under the stipulation the pharmacies couldn’t sell that product to someone without a prescription. That was already a private sector decision. The Food, Drug, and Cosmetic Act said there is nothing about this act that is in any way intended to infringe upon a person’s right to self-medicate. They actually use that terminology: “We just want to make self-medication safer.”
By 1951, what was happening was that pharmacists would occasionally make the mistake of selling a product to a person over the counter that they realized after the person already left the door was a prescription-only product. Senator Hubert Humphrey, who later became vice president, was a pharmacist before he got into politics. Lobbyists complained to Humphrey and Durham, and the Humphrey Amendment to the Food, Drug, and Cosmetic Act was passed in 1951. It said from this point forward, we’re taking this decision out of the hands of the private sector, and the Food and Drug Administration is going to decide what is going to be over the counter and what is going to be prescription only. If a drug that is originally approved for prescription-only use and later the manufacturer wants to reclassify it as over the counter, it spelled out in writing a process that the manufacturer had to go through to get the FDA to approve whether or not the drug can now be moved over the counter.
For example, ibuprofen came out in 1974 as a prescription only drug and it took 10 years later to get the approval of the FDA in 1984. That is an example how drugs can go from prescription-only to over the counter.
Bob Zadek: Let me just interrupt to bring the audience up to up to date where you are in your story. The decision of what drugs you could take before 1951 was between you and your physician. After 1951, a profound change happened. That basic decision about medication was taken from the physician and the patient and given to the government. Is that a fair summary of where we are so far?
Jeff Singer: To be more precise, the decision was always with the patients, who would consult their physicians. Even if the physician wrote a prescription, the patient could sometimes get another opinion from the pharmacist.
At the end of the day, the patient would decide what to take, not the physician. But the overwhelming majority of the time, people would want the advice of a person who was an expert so they would consult a physician. This change was a reversal of respecting the autonomy of the individual patient. All future decisions also became subject to politics, because now you have all different special interest groups in competition and these extraneous political concerns that influenced whether the Food and Drug Administration would make something currently prescription over the counter or vice versa.
We point out in our paper that contrary what people think, it actually did not increase safety. Sam Peltzman was an economist who did a lot of work on this. The research showed that since that requirement went into effect, the percentage of drug poisonings actually increased relative to the time before the prescription requirement was put in place by the FDA. And there were a lot of different reasons for it.
“The research showed that since the [prescription] requirement went into effect, the percentage of drug poisonings actually increased relative to the time before the requirement was put in place by the FDA.”
When the sulfanilamide disaster occurred, out of those 105 deaths, 95% of people who died from sulfanilamide were taking it at the doctor’s recommendation. If you look through the records, there were people who were calling the doctor and saying, my little girl is getting sicker and sicker. And the doctors would say, “Okay, then give more sulfanilamide, double up on it.” So they were following the advice of the doctor, these were not people who were doing something reckless to themselves.
There is a lot of empirical evidence in our paper that people tend to be much more willing to trust the expert when they get prescription drugs than when they go over the counter. Over the counter, you do a lot more due diligence and you start asking a lot of questions instead of just assuming the doctors are the experts.
In the United States, the American College of Obstetrics and Gynecology has for the last 15 years officially encouraged the FDA to make them make birth control pills available over the counter. That means something because if 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 a birth control pill, you should be able to go get it yourself.”
So they’re giving up money. Despite that, it is still prescription-only in this country.
At the University of Washington in Seattle in 2016, there was a really interesting study done where they asked women to self-screen with a questionnaire. They asked them to determine based upon the question whether they think they are a good candidate for oral contraception, because there are certain contraindications. What they found was that the women who self screened were in agreement with professionals 90% of the time, and the 10% of 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.
Of course, that can mean one of two things, it can mean either the doctors were reckless, or that the women were overly cautious. We don’t know 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. There’s a tendency for them to surrender judgment.
“Just because it’s prescribed by a doctor doesn’t necessarily mean that it’s foolproof.”
I’ll be the first to admit doctors make mistakes. I would argue that there’s not a single doctor who will deny this. 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, I wrote a prescription for this infection and this patient is taking an anti-anxiety medication. The pharmacist says, “Well, I don’t know if you’re aware, but that particular antibiotic has a terrible interaction with that anxiety agent so I really don’t recommend that you prescribe that.”
And I’ll say, “I wasn’t aware of that at all. Thank you for letting me know.”
Obviously, pharmacists are professionals who know more about this stuff, usually, than we doctors do.
Then a pharmacist would say, “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. Just because it’s prescribed by a doctor doesn’t necessarily mean that it’s foolproof.
The Modern-day Politicization of Medicine
Bob Zadek: That’s a perfect segue. Speaking about politicization, share with our audience the story of Plan B, because that tells us a perfect example of how politics rears its ugly head and interferes with a medical decision and produces a result contrary to the best interest of both Americans.
Plan B is also known as the “morning after pill.” It is also called “emergency contraception.” So you could take it the morning after and it will prevent pregnancy. This was approved by the FDA for prescription only in 1999. Various groups were petitioning the FDA to make it over the counter because obviously we were trying to do away with unwanted pregnancies. It’s very safe, you can’t take a lethal dose. The worst thing that can happen, if you take an overdose of it, is that you would have severe nausea, and you may miss a couple of menstrual periods. That’s the worst thing that could happen.
Jeff Singer: The advisory panel for the FDA in 2003 overwhelmingly recommended that it be made over the counter. This was during the George W. Bush administration, and the Bush administration overruled the advisory panel and chose not to make it over the counter.
Finally, after basically a court case in 2004, the FDA did make plan B over the counter, but only for women 17 and up. Then over the next several years groups were arguing that it should be available for all ages. Number one it is not lethal, and number two, you want to prevent unwanted pregnancies in all ages. If you have to get a prescription, and you are 15 years old, then that may mean that you got to the doctor, which means you have to usually tell your parents and maybe go on their insurance and maybe you didn’t want to tell your parents.
The advisory panel in 2011 overwhelmingly recommended to the FDA, that it would be available for all ages, and the FDA was about to do so, but the Secretary of HHS Sebelius in the Obama administration overruled it. President Obama, when asked why he didn’t allow the FDA to do this, said, “I don’t want little girls buying the morning after pill along with bubblegum and batteries.”
Finally it went to court and a federal judge in 2013 and ordered it to be available over the counter for all ages. A 12-year-old could buy a lethal dose of Tylenol over the counter with no questions asked, yet, they couldn’t buy a non-lethal dose of plan B.
Most countries have emulated our FDA system. We have a table showing examples of this in several countries. There are drugs that are prescription-only in our country, but are over the counter in other countries that are just as developed and just as advanced.
For example, in the United States, there are two types of insulin that you can still get over the counter. That’s because they were available already before the Food, Drug and Cosmetic Act, so they were grandfathered in. You can go into a pharmacy and request to purchase it. A lot of times the pharmacy tech may say you need a prescription. Just ask to speak to the pharmacist and the pharmacist will say “no you don’t.”
Every other type of insulin is prescription only. The over the counter is so much cheaper. Now in Canada, all insulin is over the counter, and the same is true for Singapore and for Tanzania. In the United States, there is one state that doesn’t allow even that grandfathered insulin over the counter –that is Indiana.
To take Naloxone, and now the FDA is encouraging everybody to get it available, in this you still require a prescription for it. But it’s over the counter in Australia, in Italy, and in Canada. They have had to do workarounds because of the opioid crisis. If your state has a chief medical director who happens to be a physician licensed to practice medicine in that state, then that physician is issuing what’s called a “standing order.” So basically the physician is saying, I’ll be the doctor giving you orders so all pharmacists in this state be advised, I am prescribing naloxone. But this only works if your medical director is a licensed physician.
Under the Food, Drug and Cosmetic Act and the Durham Humphrey amendments, when a drug is prescription only, that simply means that the FDA has said that this can only be available by a prescription from a healthcare practitioner licensed by the state. Now it’s up to the state to decide the scope of practice of each licensed healthcare practitioner. So for example, in some states, they have said we are going to allow pharmacists to prescribe birth control pills. California is one of those states. There are 11 of them.
“Now it’s up to the state to decide the scope of practice of each licensed healthcare practitioner.”
The woman doesn’t have to go and sit in the doctor’s office for an hour and take time off from work and pay hundreds of dollars for the prescription, but I still have a problem because they still have to get permission from the pharmacist. At least it’s eliminating some of the cost and inconvenience and they can go to the pharmacy counter to get the birth control pills.
In California in the last year, the HIV pre-exposure prophylaxis and post exposure prophylaxis is now able to be prescribed by pharmacists. So it is up to the state to decide what the scope of practice of a licensed healthcare practitioner is.
As far as the FDA is concerned, as long as it is prescribed by a health care practitioner, licensed by the state, we don’t dictate who that healthcare practitioner can be. That’s up to the state.
Reform or Reformation?
Bob Zadek: Your paper is entitled “Drug Reformation.” You have described the existing system full of politics and of non-medical considerations. What is the “reformation” you call for? What would be the economic and the medical benefits and detriments if there are any to drug reformation?
Jeff Singer: What we argue is that ending the prescription requirement number one, most importantly respects patient autonomy and the right to self medicate. When you say ending the prescription requirement, what would be different? Ending the government’s power to require prescriptions respects the right to self medicate and patient autonomy and likely increases safety.
Also it will likely lead to reduced drug prices. There is a large amount of empiric evidence that when drugs move from prescription only to over the counter, the prices drop dramatically. We argue that we need to end the prescription requirement.
Then when people say, Well, what would happen if the FDA gets out of that business? You’re not going to see a lot of changes. There is a really good likelihood that for 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 will also have liability concerns. On the margin, a lot of the routine and everyday jobs that can be moved to over the counter will get moved to over the counter, especially due to market forces and competition. That will save people a lot of money. In addition to that, you’re going to probably have more patient engagement in their self medication. There is a lot of room for innovation.
It doesn’t have to be a binary prescription or over the counter. In many of the other countries, there’s a there’s a third category, which is “pharmacist only” or “behind the counter.” So for example, 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 bandages and go to the checkout counter, you have to ask the pharmacist for it. 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. A pharmacist has the right to say, “I don’t want to sell it to you.”
When these things are over the counter, there are so many more innovations that can become available. For example, if birth control pills were over the counter, or if Naloxone was over the counter, you wouldn’t just have to go to a pharmacy for over the counter drugs, you can get them at convenience stores, at the checkout counter in supermarkets, and maybe even in vending machines. They already are making the plan B available in vending machines many places and college campuses.
By the way, there are companies now that have kiosks where you can do all your pharmacy at a vending machine. That’s already in existence. There is so much room for innovation but right now the FDA is standing in the way.
The Economics of Drug Reform
Bob Zadek: You mentioned economics. Tell us a bit about the drug manufacturers, because they can designate whether a new drug is prescription only or over the counter, but they don’t have ultimate control. The government has the ultimate control. Tell us a bit more about how that works with a system to produce lower prices to consumers?
Jeff Singer: There are three ways in which a drug can be converted today under today’s law from prescription to over the counter. One is if the manufacturer petitions that the FDA reconsider it.
Secondly, any interested person can petition it, and three, the commissioner could just decide to make it over the counter.
And then the fourth way, of course, is for Congress to pass a law saying it is over the counter. Generally speaking for the last 20–30 years, the FDA has deferred to the manufacturer, regardless of what individual groups have petitioned for. And what we’ve seen is that because health insurance generally covers prescription drugs but not over the counter drugs, that gives manufacturers a great opportunity to game the system. The company charges a very high price, much higher than any individual is willing to pay, and then of course, it gets negotiated down to a lower price and it will still do quite well.
There has been a tendency of late for the drug manufacturers not to want to make it over the counter. An excellent example of this is antihistamines. This is also an example how a prescription requirement doesn’t necessarily mean it’s safer. The over the counter ant-histamines were very sedating. Benadryl, for example, is so sedating that the FAA wouldn’t allow a pilot to fly a commercial airplane under the influence of Benadryl.
In 1993, Schering came out with the first non sedating antihistamine, Claritin. Shortly thereafter, Zyrtec and Allegra came out with the same thing and these were prescription only. You had this situation where the safe, non-sedating and histamines you needed a prescription for, but the more dangerous over the counter sedating antihistamines you didn’t need a prescription for. Schering was lobbying the regular regulators in Europe to make Claritin over the counter, and it was.
It was over the counter in Europe, it was prescription in the United States. In the late 90s, some health insurance plans 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 actually protested and lobbied successfully against making it over the counter argument is not safe. So at the same time, they’re arguing to European regulators that this is safe and to be over the counter. They are 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. Finally in 2002, Schering came up with a new non-sedating histamine and they agreed with the FDA to make Benadryl over the counter because the new drug was so good that it will compete very, very effectively against the sedating antihistamines and they could make a ton of money on both prescription and non-prescription one with the new product about to come out and on the OTC line with clarity.
There’s a perfect example of where it has nothing to do with safety and all to do with financial incentives.
The same thing happened with naloxone. The FDA has been begging the manufacturers to make it over the counter. The FDA asked the manufacturers to ask us to make it over the counter.
Commissioner Scott Gottlieb at the time said, “We don’t usually do this, but since we are already taking the going to the trouble of filling out the application for you and we’ve pre-approved the labeling for the over the counter version of your Naloxone would require, just sign on the dotted line and we’ll go ahead and get the process rolling.”
But they won’t do it. The lobbyists for the makers of Naloxone were trying to contact us before the meeting trying to make the argument that it is actually cheaper for the people if it’s prescription only. I said, “I’m really curious to know how you could say that.”
It’s $145 for two Narcan nasal spray packets, but you only have a $10 copay when you pay for your insurance, whereas otherwise it would be $145. Of course, my response was that people using IV heroin on the streets don’t usually have their insurance cards with them.
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 we can allow market competition to to enter the fray.
In our paper, we actually spent a lot of time talking about other aspects of the regulatory system that need reform, but this is an important one and it’s an important place to start. It will go a long way towards improving affordability and safety.
Also in our paper, with data from the Bureau of Labor Statistics, we found that even though birth control pills were 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 that pocket. Up until about 2011, when the ACA officially went into effect, the price of birth control pills was actually trending down and following the same trend line of over the counter medications, and prescription pill 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 purchaser of birth control pills, not only did prescription drug prices start going up, but birth control pill prices started going up and they actually skyrocketed to three times the rate of prescription medicines going up. What happened was that as the cost and the feedback loop of people purchasing birth control pills disappeared and the insurance companies were picking up the tab, the manufacturers started overcharging because they could to the third party.
Of course, not everybody has health insurance. There are a lot of women, particularly low-income women, who are now priced out of the market for purchasing out of their own out of pocket birth control pills, because of the way the price has gone up.
Bob Zadek: Even though one can say the insurance companies picked it up, the insurance companies are determined to make a profit, so therefore, the premiums go up proportionately, which means of course, consumers ultimately pay in the end.
They pay for the increased cost of their medical insurance, which means society bears the entire cost of subsidizing the people who actually use the medication, the prescription of birth control. Government has long since discovered that if they can pass a cost along to business to bury it in the price of the product, consumers don’t know that the government has increased the cost because it is buried like sales tax. Explain the FDA’s role in determining the effectiveness of the drug. Should they be involved at all as to whether a drug works?
Jeff Singer: So, one example about this is regarding a drug called “thalidomide,” which was given to women and was prescribed by doctors without them telling them it was experimental, for nausea and pregnancy. It caused terrible birth defects. Congress swung into action.
They said, “Okay, from this point forward, not only are we tightening up the safety requirements, but we are 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, I don’t understand. The drug was very efficacious. It really worked well to prevent morning sickness. By the FDA requiring these clinical trials that we are hearing about now, for example, with drugs for COVID, it takes on average 12 years and about $500 billion to bring a drug to market.
Once it is approved as having efficacy for condition A, because when you select your new drug application, you have to tell the FDA what you want it to be used for, as the FDA is concerned, they trust clinicians to use their knowledge of the research and the clinical data that is seen to prescribe it for anything else condition B through Z. So of course, it makes the question, “Why do 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-Z?”
Bob Zadek: Jeff’s paper, his white paper is drug reformation and the 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.
Links:
- Drug Reformation: End Government’s Power to Require Prescriptions by Jeff Singer and Michael F. Cannon, White Paper, The Cato Institute [Oct. 20, 2020]
- Health Care | Cato Institute
- @Dr4Liberty, Follow Jeff Singer on Twitter
Related Shows:
- Unprepared: Government Failure at the CDC/FDA with Alex Tabarrok
- The Other War on Drugs, with Jessica Flanigan, Aug. 10, 2018
- Opioids and the Agony of the American Health Care Act
- Dr. Jeffrey Singer on Gary Johnson vs. The Lesser of Two Evils
- Dr. Jeff Singer on the Dangers of Opiophobia
Originally published at http://bobzadek.com on November 21, 2020.
