The 30-day period since publication of Charley Hooper’s and my article has passed. Here’s the whole thing:
Be Thankful for High Drug Prices
If Americans weren’t overcharged, we wouldn’t have innovative treatments.
By
David R. Henderson
and
Charles L. Hooper
Feb. 4, 2024 at 4:16 pm ET
Who wants to pay for expensive drugs? No one, including Joe Biden, Donald Trump, Ron DeSantis and Bernie Sanders, wants Americans to pay for costly drugs. Mr. Trump has advocated policies to lower drug prices. Gov. DeSantis wants Floridians to be able to buy drugs from Canada. Sen. Sanders wants to subpoena the CEOs of drugmakers that have challenged the Inflation Reduction Act’s price “negotiations.” President Biden signed the act.
Who wants drugs that will save lives? Everyone we know.
For Americans, paying for the discovery and development of new drugs rests on our shoulders. If we pay, we get new lifesaving medicines. If we don’t, we don’t.
Almost all new drugs are developed for the U.S. market, no matter where the company’s headquarters are. Why? America is a large, rich country with an advanced medical system. America’s gross domestic product per capita is 65% higher than Britain’s, 57% higher than Germany’s and 87% higher than France’s. There are four Americans for every German and nine Americans for every Canadian. We have many wealthy people. The Food and Drug Administration, which moves slowly, is still often faster at approving new drugs than regulatory bodies in other countries. While far from a free market, our medical system is freer than in many other nations. Countries with single-payer systems often take one to two years to negotiate the price of a new drug. If a patent is granted for 20 years but the first 13 years are dedicated to development and approval, then only seven years of patent-protected sales remain. If two years are added to that timeline for reimbursement negotiations, the interval drops to five years.
If new drugs can make it in America, they are developed. If they can’t, they aren’t. Other countries are considered secondarily. They are the cherry on top; we’re the sundae.
While only 4% of the world’s population, the U.S. often accounts for half or more of worldwide revenue for a new drug. The cancer-fighting drug Keytruda was Merck’s top-selling product in 2022, generating sales revenue of approximately $20.9 billion. Around 60% of Keytruda sales were in the U.S. In the U.S., we pay for drug research and development while other countries free-ride on our investments.
Why do other advanced countries get their drugs more cheaply? They have monopsonistic government agencies that negotiate drug prices with the attitude that if they can’t get it cheaply, their citizens will do without.
Pharmaceutical companies go along with this because drugs have high upfront costs and relatively low incremental costs. After those upfront costs are paid by someone, drug companies decide that the extra revenue, perhaps from Canada, covers incremental costs and is better than nothing. Drug companies would prefer that everyone pay the high price, but they have little control over the situation. If the price is too low in Canada, the company won’t launch there. Sometimes, a drug company must accept Canada’s low price or grant a compulsory license to a producer of a generic version, even though the patent is still in force.
Americans should be free to purchase drugs from any willing pharmacist, even those in Canada. But don’t expect that to move the needle. Canada’s government is likely to restrict exports so that American buyers don’t scarf up all the drugs. In 2020 Canadian Minister of Health Patricia Hajdu ordered companies not to export any drugs if those sales would create or worsen shortages in Canada.
Capitalized drug development and approval costs have increased at 7.5% a year in real terms since the mid-1970s, when the cost to develop a new drug and secure FDA approval was estimated at $179 million. It has now certainly surpassed $6 billion. Most drugs are less expensive to develop, but the $6 billion figure accounts for the “dry holes” (about 82% of drugs that pass preclinical testing still fail in clinical trials) and the time value of the money spent many years ago. This amount doesn’t account for post-approval clinical trials that the FDA often requires.
Longevity is highly correlated with drug R&D. Columbia University economist Frank Lichtenberg has found that modern drugs were associated with 73% of the increase in life expectancy that we’ve enjoyed in the last few decades.
Some people claim that the American medical system isn’t very good because American life expectancy isn’t top tier. But as we know, Americans aren’t always models of health, moderation and safety.
No one in this country is happy that Americans pay for drug R&D while the rest of the world free-rides off our investment. But we don’t run the world. If we try to free-ride too, there won’t be a ride. When we look at our situation as it is, not how we wish it were, we can see what a good investment drug R&D is and how cheap-drug schemes such as importing drugs from Canada and “negotiating” Medicare drug prices generally won’t work. If they do, we’ll wish they hadn’t.
Mr. Henderson is a research fellow with Stanford University’s Hoover Institution. Mr. Hooper is president of the life-science consultancy Objective Insights and author of “Should the FDA Reject Itself?”
READER COMMENTS
Craig
Mar 8 2024 at 9:35am
“Why do other advanced countries get their drugs more cheaply? They have monopsonistic government agencies that negotiate drug prices with the attitude that if they can’t get it cheaply, their citizens will do without.”
This isn’t wrong but I think there’s a wrinkle here you might be overlooking. Indeed national health services are monopsonies who in this case are bargaining with the patent monopolist, but that does then beget the question of why CVS can’t negotiate a better price than national health services that buy far less vokume than CVS? Ie Portugal, Netherlands, Denmark ie the smaller European nations.
Secondary to this would be public payors like Medicare, Medicaid and the VA.
I’d also suggest patents are statutory rights, they’re not fundamental rights. The work of the goldsmith quickly becomes the work of the tinsmith indeed stuff isn’t THAT hard to manufacture (pharmaceutical grade more difficult of course but by way of example there’s high school dropouts cooking meth in the woods where I live in TN). So why should I pay taxes to protect the patent of the likes of Gilead, a US corporation, to sell Harvoni, an HepC cocktail in the US for 64k+ but sell for less to Canadians or Europeans, why shouldn’t I insist that the patent be contingent on receiving MFN treatment? Pigs get greedy hogs get slaughtered, the patent monopolist wants monopoly pricing AND market segmentation based on third degree price discrimination? Cmon….
Excuse is US wealthier, higher per capita GDP and yet I go to the CDC and it says TN life expectancy is 73, MS is 71 and I think TN technically wealthier than Germany on a per capita basis? I’ve seen the stats along these lines of course but then yiu go there and yeah, uh, hmmm, really DOES NOT look like it, does it?
As for Canadian pharmacies, I agree Americans should be able to buy and they wouldn’t scarf them all up. The Canadian pharmacies would just order more, the problem is the patent holder is placing restrictions on resale. Becomes grey market and they take actions to prevent arbitrage from equalizing the markets and its not just vz Canada but also Mexico in particular but with respect to Harvoni they charged a high enough price in US they were also worried about people flying to India, Egypt etc where it even less than Europe like 3k per course and here one can make a better argument for the necessity imposed by third world poverty.
Airman Spry Shark
Mar 8 2024 at 1:12pm
They’re only monopolists if the monopsonists let them be; foreign governments just steal the patents from drug companies that won’t roll over.
[I’ve fixed your blockquote for you.–Econlib Ed.]
Charley Hooper
Mar 8 2024 at 6:24pm
There are multiple reasons for this.
1: CVS can’t invalidate a drug’s patent. That threat works for Canada but not CVS.
2: If a drug company gives a good price to CVS, then every other large pharmacy will expect the same price. In essence, giving a low price to CVS means giving a low price to all (or most) American pharmacies.
3: CVS doesn’t usually buy the drug in question. CVS is simply the place that the prescription is filled. It might be Aetna that has actually bought the drug and is providing the drug to one of its customers in exchange for monthly premiums and out-of-pocket copayments. CVS is where that exchange happens. (Note that Aetna now owns CVS.)
4: The drug company knows that CVS, or really Aetna, will pay a reasonably high price. Aetna would like to get the drug at a really low cost. But Aetna also wants to supply its customers with the drug. The drug company and Aetna/CVS actually do engage in negotiations and Aetna/CVS might get a 10-40% discount off the list price based on volume (the discount depends on many factors).
So Aetna/CVS is already trying to do what you suggest.
I may think of other reasons, but this highlights one of the weaknesses of comparing prices across countries. The price published in Canada is the price. The price published in the U.S. is often the list price, which is just the starting point for negotiations.
David Henderson
Mar 8 2024 at 8:15pm
I’m glad that Charley answered the CVS question.
Now to a couple of other of your points,
You write:
I don’t think you’re paying taxes to protect patents. My understanding is that entity that pays the legal fees to enforce patents is the patent holder. Also, the Most Favored Nation applies to tariffs, not drug prices. So I assume you using the term to say that if other countries get to pay the low price, we Americans should to. To answer that question, read our article. That’s what it was about.
You wrote:
Exactly. We dealt with that in article almost 20 years ago but had a space constraint for this article. We predicted then that drug companies would respond by limiting sales to Canada and that is what they did. It didn’t require any intervention by the U.S. government.
You write:
I agree. They are the kind of intervention that has to be justified based on the intervention’s effects, not based on some kind of natural rights. That’s why I think drug development, given the FDA’s road blocks, absolutely requires patents in a way that other inventions may not.
Craig
Mar 8 2024 at 9:13pm
Thanks to both for responding.
Of course most favored nation has the most direct sense in applying to international/trade tariffs, but contractually the analogy is made to contract law and most favored nation clauses as they are called off the cuff are contract provisions that require that a party must receive rights and benefits under the contract that are equal to or more favorable than the rights and benefits received by any other parties. And of course you did correctly glean the context I was using the term in.
steve
Mar 9 2024 at 9:57am
Absent the FDA how much faster do you think drugs would develop. Speaking for the doctor groups we would still want to see the same studies so I dont see that changing. The only part I think would really be affected would be the FDA review period and most docs like to see what panels of experts in their own field have to say about new drugs before using them. I think you would just see slower uptake. Anyway, what other roadblocks would be dropped?
Steve
David Henderson
Mar 9 2024 at 11:07am
You wrote:
Much faster. The regulation that added years to the approval process was the 1962 requirement to show efficacy.
You wrote:
I strongly doubt that. Many, many doctors prescribe drugs that are not approved for specific uses. The term is “off-label.” Doctors often experiment with drugs approved for use A and try them in use B. A famous example is Prozac. It was not approved for post-menstrual syndrome. But some doctors decided to try it for PMS and got good results. Then it was written up in medical journals. That might be the kind of study you’re referring to. But notice that docs prescribed it based on studies in medical journals, which is different from using it based on studies that the FDA requires. Ultimately Eli Lilly found the PMS business so lucrative that it went thought he process of getting it approved for PMS. But that took substantial time. Meanwhile, many doctors were prescribing it for PMS.
Bottom line: using Prozac for PMS allowed women to get relief years before they would have if they had to wait for the FDA to approve it for PMS.
Jon Murphy
Mar 9 2024 at 1:02pm
The response to COVID may give us an indication since COVID shots and treatments were authorized under EUA, which waives a lot of FDA requirements. The EUA was sactioned in March 2020. We had shots ready to go in arms by September 2020, 6 months later. In the US, it takes about 10-15 years for new drugs to develop, go through approval, and come to market. So, we can estimate that the FDA adds approximate 9.5-14.5 years to the process at the high end.
Now, obviously several huge caveats to this estimate. It’s a real quick and dirty back-of-envelope calculation and should not be treated as anything more.
But I think it is reasonable to assume the FDA does at years to the development process. The question is whether or not it is worth it.
Charley Hooper
Mar 9 2024 at 2:44pm
Jon Murphy raises good points about the COVID-19 pandemic. One other aspect of the pandemic addresses another one of your points.
We didn’t get those studies with the mRNA vaccines. They were barely studied and, as Jon points out, they hadn’t received FDA approval at the time they were given to hundreds of millions of Americans.
These mRNA vaccines were essentially experimental and were only lightly tested and didn’t have the FDA’s blessing and yet they were often required for students and employees.
Karen Tibbals
Mar 9 2024 at 3:10pm
https://www.econlib.org/why-high-drug-prices-are-good-for-us-americans/#comment-339219
No, the FDA didn’t get out of the way, they participated in operation warp speed in figuring out how to approve the vaccines quickly. They streamlined the process – for example, instead of each manufacturer negotiating the clinical study design individually (a process that can take months), the FDA required a standard sample size of 30,000. The drugs were not “lightly studied” – they met the same criteria as normal vaccines do. They finished the trials more quickly than usual because there were lots of people getting sick because we were in a pandemic. Most vaccines aren’t studied during a pandemic.
steve
Mar 9 2024 at 3:25pm
I use lots of drugs off label, but that is because I have efficacy studies to support their use. Heck, I do some pediatric care and lots of drugs never get approved for kids. The claims that we should eliminate efficacy studies just baffle me. Why would I use a drug if I have no idea if it works? How would we even know what doses to use? You are going to need to do efficacy studies regardless of whether or not they are submitted to the FDA.
In some idea world every doctor individually reads the studies for every new drug. The reality is that many docs wait to see the recommendations put out by their professional societies and those often look at the recommendations done by the FDA approval committees since they largely will ask the same questions.
m-RNA tech has been around for a couple of years. If you have an antigen you can design a vaccine in a couple of days. That does not describe most drug development. The development was greatly accelerated because there was no financial risk. Drug companies could start phases right after one another as they were already paid for.
The covid vaccines did have efficacy testing. You can claim they were tested too long, to hurt Trump is the usual claim, or claim they were not tested long enough, but there was efficacy testing. Put in context, we have been making vaccines for a long time and have a good handle on their risks so knowing the priors it was less risky to not have extended testing. That would not be true of other drugs as a rule. Also, as I suspect you know, the FDA has released other drugs under emergency release authorization.
Suggestion- All you guys at your next doctor visit should ask them if they would order a drug with no information on efficacy.
Steve
Jon Murphy
Mar 9 2024 at 3:30pm
Steve-
Given your comment, I fail to see what positive benefit the FDA actually provides. It sounds like, at best, their duplicating a process doctors are already doing.
Jon Murphy
Mar 9 2024 at 3:41pm
Steve-
I’m not really sure what your follow-up comment is getting at. It’s pretty irrelevant to the conversation thus far. You asked what the delay is for FDA approval. I have one estimate using COVID-19 drugs (not just shots but other treatments) as a proxy. A quick Google search finds that it depends on the type of drug (Cancer drugs can take a decade, others can take a few months).
But now you’re discussing efficacy tests. It’s quite the switch. Now, I didn’t say anything about whether or not such tests are necessary. Neither did Charley. The implication of your comment is that the FDA doesn;t provide any useful service on that area as well. So, why’d bring it up?
Andre
Mar 8 2024 at 10:38am
“Columbia University economist Frank Lichtenberg has found that modern drugs were associated with 73% of the increase in life expectancy that we’ve enjoyed in the last few decades.”
This looked like deceptive spin to me. So I just pulled up a US life expectancy chart, went back three decades to 1990, and compared that year’s 75 years to the 2021 figure of 76.4 or thereabouts. 73% of that increase is about 1 year of additional life expectancy. Even with a bounceback in 2022, 2023, we’re still talking only a couple of years of life expectancy due to drugs – and a that most likely is unhealthy end-of-life extension.
Is all the expense worth that? I don’t think so. Just eating more vegetables and fruits would reduce the bill and extend healthy life expectancies more than these drugs have. But nah, let’s just spend the money. It’ll be fine.
Richard W Fulmer
Mar 8 2024 at 11:59am
Then don’t buy drugs. That causes no issues as long as you’re willing to allow others the freedom to spend their money on expensive drugs if they so choose. Everyone gets what they want, everyone is happy.
Conflicts arise, though, when government forces people to pay for others’ drugs, and when it prevents people from obtaining medication that they and their doctors believe would be beneficial.
steve
Mar 8 2024 at 12:16pm
This is what the study actually said.
“the increase in life expectancy at birth due to the increase in the fraction of drugs consumed that were launched after 1990 was 1.27 years–73% of the actual increase in life expectancy at birth.”
It’s an older study. Total life expectancy had increased by 1.74 years. It does have some issues. It discounted the effects of increased income and education claiming those had nothing to do with life expectancy, which is clearly wrong. It’s also a study that involves first world countries and poor countries. The study was done in 2000-2009 when PEPFAR came along so the study is heavily influenced by HIV drugs which would largely be after 1990. AFAICT, it’s a very long study, it discounts diagnostics and the personnel needed to treat. I guess you just magically get a diagnosis and then have the right drug available to treat. I could have missed it as I started glazing over but it looks like nearly all of the increase is attributed to the drugs and little or none to other parts of the medical system.
Anyway, what I think the study shows is that if a major new disease occurs you need new drugs. It also illustrates that poor countries are very dependent upon very old, generics since they cost less and if they can get access to some newer drugs they can help. This may or may not apply so well to the US.
Steve
Charley Hooper
Mar 9 2024 at 2:58pm
One thing I think many people don’t understand is that there are old drugs, current drugs, and future drugs.
Old drugs are generic and generally inexpensive, although sometimes not available.
Current drugs are patent-protected and generally expensive. However, in a few short years (1-10) those current drugs will become old drugs.
Future drugs won’t ever exist unless current drugs are successful. The characteristics of current drugs drive the investment in future drugs.
If you think that current drugs are too expensive, don’t complain, just wait a few years and they will be inexpensive. The “drugs are too expensive” argument rests on the view that current drugs are so important that we can’t wait a few years until the patents expire. Are those with this view really willing to forgo future drugs to get current drugs a bit cheaper today?
Acad Ronin
Mar 9 2024 at 10:39am
One minor point and one question:
Minor point: successful drugs must pay not only for the dry holes in the companies that produce them, the successful drugs must also pay for the dry holes that caused companies to fail. When I buy a portfolio of drug companies, I hope that over the years the portfolio will return an appropriate risk-adjusted return, even though some of the companies that were in the portfolio originally failed in the interim.
Question: If the United States imposed an anti-dumping statute that forbade US companies to sell abroad at a lower price than they sold at home, what would happen? Some countries would end up engaging in compulsory licensing. Also, to the degree the statute prevented price discrimination, it would probably reduce drug profitability, harming R&D spending, but what else?
Charley Hooper
Mar 9 2024 at 3:08pm
You wrote:
The problem is there isn’t one price. A cash customer might pay $100. A hospital might get it for $80. An insurance company might get it for $75. Medicaid might get it for $70.
Which price would we use for the comparison?
Plus, all of these companies are international. They might have their headquarters in the U.S., England, Switzerland, Japan, or elsewhere. Would this only affect companies with headquarters in the U.S.? Companies with manufacturing in the U.S.? Companies with sales in the U.S.?
The problem is with government purchasers in Canada, the U.K., Japan, etc. It is possible that this law would put American producers at a disadvantage.
Acad Ronin
Mar 9 2024 at 4:51pm
Thanks. Both points are ones I should have seen unaided, but didn’t.
johnson85
Mar 11 2024 at 11:36am
To me it seems fairly easy to have a provision that Medicaid won’t pay more than the average paid by OECD countries and Medicare won’t pay more than some percentage (say 10% just to pull one out of thin air, but maybe the right number should be 15%) over the average paid by OECD countries (or maybe it should just be what Germany and Canada and one other high income OECD country pays).
Other countries would of course try to game that so some thought would have to be put into the language used. You could probably get the drug companies to comply with the spirit of the law by making them subject to retroactive penalty for all drugs sold in the US during the period of gamesmanship.
If other countries tried to force drug companies to provide a compulsory license, if it’s a US company we should be able to protect them. If it’s a non-US company, they will have to decide whether to abandon the other country’s market entirely or to let them essentially dictate the price for the US also.
bill
Mar 9 2024 at 12:45pm
Our interest is in the drug companies being paid for their innovation. Not necessarily from them being paid by us (US consumers). I would like the US government to cap US prices at 110% of the prices paid by other advanced economies (a peer group could be established). The likely result would be the drug companies raising prices to those peers (Canada, Germany, France, etc) because the cap would change the marginal revenue math for them if it meant reducing prices in the US. That would mean More revenue for the drug companies, not less. At the same time, it would probably reduce some prices in the US.
Charley Hooper
Mar 9 2024 at 3:10pm
Please see my response to Acad Ronin.
johnson85
Mar 11 2024 at 11:38am
The US doesn’t have to try to get into the business of regulating private prices. It will move the needle substantially to just make sure Medicare and Medicaid aren’t subsidizing development in comparison to the government healthcare organizations of other rich companies. Or at least not subsidizing them disproportionately in comparison with the difference in per capita income.
Patrick
Mar 9 2024 at 12:56pm
As someone who agrees with your basic point, I do wonder about the “at the limit” question. There must be some price above which, it’s not worth paying. High prices, sure, but how high? Should we pay a million dollars per patient year for every treatment? There has to be some high level mechanism that determines willingness to pay (or not). How should say, Medicare / Medicare plans, decide how high is too high?
jseliger
Mar 9 2024 at 2:27pm
“This amount doesn’t account for post-approval clinical trials that the FDA often requires.”
I’m dying of squamous cell carcinoma, and I’d love to see the FDA ease back on requirements for fatal diseases—instead of letting people like me die in the name of “safety,” which is really safetyism: https://jakeseliger.com/2024/01/29/the-dead-and-dying-at-the-gates-of-oncology-clinical-trials/
BC
Mar 9 2024 at 5:27pm
I understand that price discrimination turns consumer surplus into producer surplus. In turn, that allows drug companies to develop more new drugs because they can earn more total revenue to pay the high fixed costs of development. However, is it unambiguous that the value of the new drugs exceeds the value of what consumers would have otherwise bought had consumer surplus been higher?
Social welfare is neutral with respect to the division between consumer surplus and producer surplus, at least directly. Shifting consumer surplus to producer surplus leads to more production by the benefitting producers when they face high fixed costs, as in the drug example. But, does that always mean an “indirect” net gain in social welfare? If so, then that would mean that producer surplus is always “better” than consumer surplus once one considers “indirect” effects from fixed costs, but I don’t know whether that is true.
BC
Mar 9 2024 at 6:28pm
As I thought about it more, I think the answer is yes, producer surplus is better (in terms of social welfare) than consumer surplus when fixed costs are significant. For allocative efficiency, we want producers to produce goods where consumers, including inframarginal consumers, place a total value on those goods that exceeds the total production cost, including both fixed and marginal costs. Producers will only incur fixed costs to produce goods where total revenue exceeds total production cost. So, for efficiency, total revenue received by producers needs to equal the total value placed on those goods by consumers, i.e., it’s most efficient when producers capture all the surplus.
Intuitively, with high fixed costs and without price discrimination, producers will tend to underproduce goods with steep demand curves and high consumer surplus relative to those with flat demand curves and low consumer surplus because the total revenue of the steep-demand-curve goods won’t reflect the high value that inframarginal consumers place on them.
First, is this correct that producer surplus leads to higher social welfare than consumer surplus when fixed costs are significant? Second, is this a well-known result in economics?
David Henderson
Mar 9 2024 at 10:01pm
Steve above keeps missing the point. I have made clear that the 1962 law required proof of efficacy and that has added years to the approval process.
Steve says that he needs to see evidence of efficacy before using a drug. Good for him and good for his patients. That’s about his requirements, not about the FDA.
Steve admits that he prescribes drugs for off-label uses. QED.
Comments are closed.