Freedom Line Blog

The U.S. House Energy & Commerce Committee’s Health Subcommittee today will host the third hearing in its health care affordability series, specifically examining the role providers and hospitals play in shaping the cost of care for Americans.

While the hearing will likely examine numerous issues, there is none more ripe for reform than the flawed 340B drug pricing program.

Originally enacted to help eligible safety-net providers buy medicines at steep discounts and pass the savings on to lower-income and vulnerable patients, the program has ballooned as a revenue stream for many participating hospitals and contract pharmacy chains.

As the size and complexity of the 340B program has expanded, participating hospitals and contract pharmacies have instead used the program to increase their own revenues – to the tune of $1.8 billion from 2024 to 2025 alone – rather than helping consumers, who were the law’s intended beneficiaries.

Study after study into that failure over the years has exposed how participating providers hoard tens of billions of dollars each year from drug sales occurring under the 340B program.  In fact, some of those hospitals went so far as to charge full prices to patients for discounted drugs, only to pocket the difference.  Federal agencies tasked with administering the 340B program have highlighted transparency concerns and the inability to accurately audit the program.

Fortunately, the Trump Administration has offered a proposal to actually improve matters for consumers.

Under the administration’s proposal, the 340B program would require hospitals to file claims with drug manufacturers for rebates, rather than the current process of granting those hospitals up-front drug price discounts.  With that change, the program would create a paper trail to prevent hospitals from exploiting the discounts in the shadows.

There have been similar successful real-world reforms enacted in other federal drug pricing programs such as the Medicaid Drug Rebate Program of 1990 and the Department of Veterans Affairs Federal Supply Schedule.  Each of those reforms created a more transparent paper trail that enhanced program efficiency in the way that the Trump Administration’s 340B program reform idea proposes.

Simply put, the 340B program, however well-intentioned, has proved to be a prescription for disaster.  In practice, its murky logistics has ended up benefiting participating providers at the expense of patients and increased healthcare costs.

Accordingly, as Congress continues its effort to reduce healthcare costs, it should focus on where reform and savings constitute low-hanging fruit:  the 340B program and the way it has to date served the interests of participating hospitals rather than patients.

As the United States Senate Finance Committee convenes today for a meeting entitled “The Rising Cost of Health Care:  Considering Meaningful Solutions for All Americans,” the enduring adage of medical care applies:  Do no harm.

Specifically, as we’ve detailed at CFIF, we must especially avoid potentially catastrophic ideas like drug price controls (whether through so-called “Most Favored Nation” (MFN) programs or any other) and violations of patent and intellectual property (IP) protections in which the United States leads the world.  Indeed, our more free-market approach explains why America leads the world in lifesaving healthcare innovation, accounting for an astonishing two-thirds of all new drugs introduced to the world each year:

The reasons that MFN schemes would only exacerbate existing problems are several.

First, drug price controls depress innovation in foreign nations such as those in the European Union (EU) that practice them.  That’s because drug innovation requires massive investments in research and development (R&D), often exceeding $2.6 billion to bring each new potential drug to the consumer market.  Consequently, when foreign governments impose artificially low prices, they necessarily strip pharmaceutical innovators of the revenue required to fund new treatments.  As a result, fewer breakthrough therapies arrive, and the slowdown in medical advances can cost lives.

As noted above, that consequence isn’t hypothetical or open to debate.  To wit, the more market-oriented U.S. accounts for an astounding two-thirds of all new drugs introduced to the world, far above our share of the world’s population or economic production.  That’s no accident or coincidence.

Second, and partly as a consequence of the dynamic described immediately above, drug price controls reduce access to lifesaving drugs.  Nations that impose them suffer from delayed drug availability and restricted access, whereas the newest and most effective pharmaceutical innovations typically reach the U.S. market first.

To illustrate, of 270 medicines introduced in the U.S. from 2011 through 2018, only 53% became available in France, 64% in Britain and 67% of them in Germany.  Only 52% of that 270 became available to Canadians, 41% to Australians and 48% to the Japanese.

If the U.S. were to adopt MFN pricing, it would foolishly import those foreign delays and access restrictions, in turn reducing American consumers’ access to cutting-edge treatments.”

Along the way, the Committee should also highlight the perils of continued subsidies for ObamaCare and the potential benefits of other patient-centered reforms like health savings accounts (HSAs) and Section 340B reform.  Healthcare costs remain an important concern for Americans, and we must promote federal policies that improve matters for consumers and patients, not harm them.

In our latest Liberty Update, CFIF highlights the debut of the “Most Favored Patient” initiative, which offers the optimal blueprint going forward for lower drug costs, greater access and better healthcare.

Well, the policy heavyweights behind Most Favored Patient come from the group at Unleash Prosperity, including Steve Forbes, Stephen Moore, Phil Kerpen, and Thomas Philipson.  And in addition to their new work at Most Favored Patient, they’ve unveiled a new commentary explaining how drug prices in the U.S. are actually cheaper than in other developed nations with which we’re often unfairly compared:

It IS true that Americans pay more for new drugs under patent. That, of course, is because American pharmaceutical companies spend billions of dollars inventing the major breakthrough drugs and the rest of the world free-rides on those R&D costs.

But most drugs consumed in the U.S. are generics. Those prices are cheap. And generics last forever, whereas a patent lasts 10 to 20 years before generics take over.

A new blockbuster study by UP senior fellow Tomas Philipson has two amazing findings:

First: “The U.S. has the highest generic market share (93 percent).”

Second: “The U.S. has some of the LOWEST generic prices among developed countries.” Medicare and Medicaid pay almost 20% less for prescription drugs than in Europe, Canada, and the U.K. It is true Americans pay more for the patented drugs, but many residents of countries with socialized medicine don’t have access to these drugs at virtually any price because of socialist price controls and government-run health care.”

Along the way, they offer this helpful illustration:

This offers just a sample of the great work from Unleash Prosperity, and also the sort of policy insight that we can anticipate from Most Favored Patient.

As we at CFIF often highlight, strong intellectual property (IP) rights – including patent rights – constitute a core element of “American Exceptionalism” and explain how we became the most inventive, prosperous, technologically advanced nation in human history.  Our Founding Fathers considered IP so important that they explicitly protected it in the text of Article I of the United States Constitution.

Strong patent rights also explain how the U.S. accounts for an incredible two-thirds of all new lifesaving drugs introduced worldwide.

Elected officials must therefore work to protect strong IP and patent rights, not undermine them.   Unfortunately, several anti-patent bills currently before the U.S. Senate Judiciary Committee this week threaten to do exactly that.  Those bills include S. 1040, which rests on the myth of a “product-hopping” problem under U.S. law.

As CFIF has explained, however, bills like S. 1040 and acceptance of the “product-hopping” falsity would dangerously threaten U.S. innovation in an increasingly competitive world economy:

Myth:  Anti-patent activists employ this deceptive term when a manufacturer introduces a new, different drug that may compete with or replace  older version and provide expanded patient choice and access.  They claim that by introducing a new product covered by new patents, biopharmaceutical manufacturers are somehow engaging in anticompetitive activity, fending off entry of generic or biosimilar competitors.

Fact:  U.S. patent law rightfully grants patent rights for new and useful improvements to existing drugs.  That incentivizes research and development and the multiple years of risk-taking and experimentation needed to make existing products even better.  Such improvements open the door for reduced side effects, lower dosage requirements, improved potency, extended effectiveness or alternative uses.  Additionally, as the COVID-19 pandemic has illustrated, it’s important to upgrade existing drugs to address potentially mutating viruses and diseases. Depriving pharmaceutical innovators of patent protections for those critical improvements or otherwise disincentivizing those innovations would mean they’re far less likely to be developed, resulting in fewer options for patients.

We cannot jeopardize America’s status as the world’s leader in innovation, including pharmaceutical innovation and availability on the basis of anti-patent myths.  Hopefully wiser minds on the Senate Judiciary Committee prevail.

Today, the House Oversight Committee is holding an important hearing entitled “The Role of Pharmacy Benefit Managers in Prescription Drug Markets Part III:  Transparency and Accountability.”

For those unfamiliar, Pharmacy Benefit Managers (PBMs) amount to middlemen that control prescription drugs for millions of Americans.  A majority of Americans receive health insurance through employer plans or government programs such as Medicare, which in turn cover prescription drugs through PBMs.  Those PBMs negotiate with drug companies and pay pharmacies, but throughout the process determine the drugs that insured patients may obtain and at what cost.

The problem is that PBMs operate in such an opaque and complex manner that they’re able to inflate drug costs while claiming to be working to reduce them.  It has reached a point where even the Federal Trade Commission (FTC) is now investigating PBMs’ role in driving up costs for Americans.

Today’s House Oversight Committee hearing accordingly offers invaluable assistance in alerting Americans to PBMs’ ongoing role in unnecessarily increasing drug prices for consumers, and hopefully helps propel reform in this critical realm.

Following up on our latest Liberty Update commentary highlighting the deepening disaster that is the Biden Administration healthcare and pharmaceutical policy, The Wall Street Journal notes that prescription drug prices have actually ACCELERATED their price inflation since Biden’s so-called “Inflation Reduction Act”:

Prescription drug prices increased by 2% during the Trump Presidency owing to greater generic competition, yet they’ve increased 5.5% so far under Mr. Biden. In November they rose at an annual rate of nearly 6%. Has the White House considered that the reason Americans don’t believe that the President’s policies have helped them is because they haven’t?”

The Biden Administration needs to correct course for the benefit of Americans, not double down.  But time is running out.

In recent days, we at CFIF have marked the ignominious one-year anniversary of the Biden Administration’s misnamed “Inflation Reduction Act” (IRA) by noting its particularly negative impact on pharmaceutical innovation and, in turn, the nation’s health and wellbeing.

As acknowledged by the United States Senate Committee on Homeland Security  as well as groups like the American Cancer Society, Americans are already confronting alarming and unprecedented drug shortages in the wake of the IRA.

To mark today’s date of September 13 – or 9/13 – it’s appropriate to note a different but significant 9-13:  That refers to the indefensible distinction that the IRA makes between what are known as “small-molecule” and “large-molecule” drugs.

Specifically, the IRA imposes destructive price controls on small-molecule drugs merely 9 years following Food and Drug Administration (FDA) approval, while waiting 13 years to impose those price controls on large-molecule drugs.  Although price controls of any duration and of any type only serve to create shortages and discourage innovation, that baseless disparity in the IRA needlessly discourages investment in small-molecule pharmaceuticals.

As cogently stated by leading scientific and medical expert Daniel Skovronsky in STATReports, it’s imperative that Congress correct that unjustifiable 9-13 distinction:

[T]o researchers like me, a provision in the recently enacted Inflation Reduction Act is puzzling.  For no clear reason, it draws a distinction between large and small molecule medicines.  As part of the IRA’s Medicare price control provisions, price negotiation for small molecule medicines is allowed nine years after Food and Drug Administration approval compared with 13 years for large molecule biologics.  There is no scientific reason for this distinction, and it will have a real and detrimental impact on drug discovery and patient care.  Nine years is not enough time to recoup the deep investments into small molecule R&D before government price controls take effect.  As a result, companies will deprioritize small molecule programs, lowering the potential to create drugs using these technologies.  Congress should correct this imbalance by allowing negotiation after a full 13 years for both small-molecule medicines and their large-molecule counterparts.”

There’s simply no sound basis for that 9-13 small-molecule/large-molecule differential, and on 9/13 we urge Congress to correct this error.

CFIF recently marked the ignominious one-year anniversary of the Biden Administration’s misnamed “Inflation Reduction Act” (IRA), whose title even Biden himself admitted was mistaken.

We noted how, as a result of the IRA, drug shortages have already reached record highs, increasing by 30% between 2021 and 2022 alone, according to a report in March from the Senate Committee on Homeland Security and Governmental Affairs.  Another report from the American Cancer Society also sounded the alarm on emerging drug shortages, caused in part by drug price control policies.  Thus, just one year in, drug shortages have reached record levels under the looming threat of drug price controls, weaker intellectual property protections and regulatory browbeating.

This week, as reported by Politico, the same Biden Administration that called inflation “transitory” and insists in the face of public blowback that “Bidenomics” is somehow succeeding announced that it will soon release the first ten prescription drugs selected for its destructive price control scheme:

President Joe Biden has sought to sell health policies like the new Medicare negotiation program as part of a broader ‘Bidenomics’ agenda set to underpin his reelection campaign.  The drug pricing push, he has argued, will help counter inflation and boost the economy by slashing the amount Americans have to shell out each year for critical medicines, although prices negotiated on the first set of drugs won’t take effect until 2026.”

Given Biden’s shoddy record for accuracy and competence so far, Americans will be forgiven for their skepticism.  As we noted, the consequence of price controls will be shortages and less innovation, which we’re already witnessing.  Americans aren’t buying this “Bidenomics” pitch, and will pay a heavy price unless and until these dangerous drug price controls are reversed.

“The record of price controls goes as far back as human history.  They were imposed by the Pharaohs of ancient Egypt.  They were decreed by Hammurabi, king of Babylon, in the eighteenth century B.C.  They were tried in ancient Athens.” -Henry Hazlitt

Today marks the one-year anniversary of Joe Biden’s misnamed “Inflation Reduction Act” (IRA), which even he now admits shouldn’t have carried that title.

Beyond Biden’s own regrets, however, Americans deserve to understand its destructive impact on our healthcare system and world-leading pharmaceutical innovation sector.

Namely, our traditional market-based approach has resulted in an unrivaled legacy of pharmaceutical innovation and abundance relative to the rest of the industrialized world.

For example, the United States accounts for approximately two of every three new lifesaving drugs introduced worldwide, meaning that we alone create twice as many new drugs as the entire world combined.  As another illustration, American consumers enjoy a substantially higher availability of critical drugs compared to people in other advanced economies.  Of 270 new medicines introduced domestically since 2011, only 52% of them were available to our neighbors just across our northern border in Canada, 41% in Australia, 48 % in Japan, 53% in France, 64% in Britain and 67% in Germany.

Destructive drug price controls, however, maintained an illogical appeal for the Biden Administration and the political left.

They can’t say that they couldn’t have foreseen the downsides of the IRA.  Amid debate over broad drug price controls back in 2021, a University of Chicago study warned of their potential negative impact on future drug innovation and availability:

The United States has far fewer restrictions on price than other countries, but the Biden Administration has announced their goal to lower drug prices through greater price regulation. …  [N]ew drug approvals will fall by 32 to 65 approvals from 2021 to 2029 and 135 to 277 approvals from 2030 to 2039.  These significant drops in new drug approvals will lead to delays in needed drug therapies, resulting in worse health outcomes for patients.  

Several years earlier, even the United Nations World Health Organization (WHO) similarly warned about the consequences of government price controls and intellectual property violations:

[P]rice controls, combined with the threat of market lockout or intellectual property infringement, prevent drug companies from charging market rates for their products, while delaying the availability of new cures to patients living in countries implementing those policies.  

Disregarding those warnings and textbook economic logic, the Biden Administration and Pelosi-Schumer Congress plowed ahead with the IRA, whose drug price control provisions President Biden bizarrely trumpets as a 2024 reelection theme.  From branded drugs to off-patent older generics, the Biden Administration accelerated government efforts to artificially target drug prices, oblivious to the foreseeable consequences.

We’re now suffering the consequences of that agenda.

Drug shortages have already reached record highs, increasing by 30% between 2021 and 2022 alone, according to a report earlier this summer from the Senate Committee on Homeland Security and Governmental Affairs:

Shortages of critical medications continue to rise – including drugs used in hospital emergency rooms and to treat cancer, prescription medications, and even common over-the-counter treatments like children’s cold and flu medicine.  The number of active drug shortages in the U.S. reached a peak of 295 at the end of 2022. …  Between 2021 and 2022, new drug shortages increased by nearly 30 percent.  At the end of 2022, drug shortages experienced a record five-year high of 295 active drug shortages.  

Separately, a new report from the American Cancer Society warns of emerging drug shortages, caused in part by drug pricing policies:

Chemotherapy drugs used to treat cancer are increasingly in short supply and have returned to the list of top-five drug classes affected by shortage.  Expanded demand, supply shortages, limited manufacturing capacity, and low profit margins for generic therapies are among the factors resulting in the current nationwide shortage.  …  A number of the drugs included in the shortage don’t have an effective alternative.  As first-time treatments for a number of cancers, including triple-negative breast cancer, ovarian cancer and leukemia often experienced by pediatric cancer patients, the shortage could lead to delays in treatment that could result in worse outcomes.  

Accordingly, drug shortages have reached record levels under the looming threat of drug price controls, weaker intellectual property protections and regulatory browbeating.

Instead of perpetuating the IRA’s spiral of price control insanity, elected leaders should return to the more market-oriented approach that brought unrivaled innovation before more Americans pay the needless cost.

For years we’ve warned how drug price controls – as with price controls on any product or service – don’t reduce prices so much as they inevitably cause shortages and stifle innovation.

Europe and other advanced economies imposing socialized drug price controls suffer dramatic shortages compared to the traditionally more market-oriented United States, and now in the wake of the misnamed “Inflation Reduction Act” (IRA), the U.S. is already experiencing unprecedented drug shortages.

This is literally a matter of life and death.

A new analysis from Vital Transformation offers the latest detail on how the IRA’s drug price controls, and the proposed “Smart Prices Act” (SPA) seeking to expand them, will stifle innovation in the field of lifesaving pharmaceuticals:

Looking forward, we estimate that the expanded government price setting could result in roughly 230 fewer FDA approvals of new medicines over a ten-year period, once the impacts are fully reflected in the pipeline.  Impacts will be felt most heavily in many areas of unmet need, including rare disease, oncology, neurology, and infectious disease.”  (Emphasis added.)

Indeed, Vital Transformation’s study illustrates how many of the drugs currently targeted by the IRA’s price controls would’ve never come to market had the price controls existed at the time:

Had the drug pricing provisions of the SPA been in place prior to the development of today’s top-selling medicines, we estimate that 82 of the 121 therapies we identified as selected for price setting would likely have not been developed.”

In addition to price controls’ impact on lifesaving drug innovation, the new study also helpfully highlights the negative economic and job effects of these price controls on the U.S. economy and employment market:

We modeled the impacts on industry revenues and future R&D investments and estimated future lost innovation impacts including the impact on industry jobs.  We estimate a loss of between 146,000 – 230,000 direct biopharmaceutical industry jobs and a total of 730,000 – 1,100,000 U.S. jobs across the economy if the proposed IRA expansion were to be implemented.”

All of this, of course, simply confirms what analysts have known for decades.  A 2021 University of Chicago study warned in equally stark terms how drug price controls will dangerously reduce drug innovation and availability:

The United States has far fewer restrictions on price controls than other countries, but the Biden Administration has announced their goal to lower drug prices through greater price regulation.  …  [N]ew drug approvals will fall by 32 to 65 approvals from 2021 to 2029 and 135 to 277 approvals from 2030 to 2039.  These significant drops in new drug approvals will lead to delays in needed drug therapies, resulting in worse health outcomes for patients.”

Believe it or not, even the United Nations World Health Organization (WHO) issued the same warning of the deadly consequences of government price controls and weaker patent protections:

[P]rice controls, combined with the threat of market lockout or intellectual property infringement, prevent drug companies from charging market rates for their products, while delaying the availability of new cures to patients living in countries implementing those policies.”

The evidence and real-world impacts are frankly beyond dispute.  Accordingly, it’s now up to reasonable members of the U.S. Senate and House of Representatives to oppose Joe Biden’s proposed 2024 budget and the SPA and avert the predictable deadly economically destructive consequences.

As we approach Thanksgiving, you may have heard (or personally experienced) that the cost of Thanksgiving dinner this year is up a record 20%.

Meanwhile, guess what’s actually declined in price, according to the federal government itself.  That would be prescription drug prices, which declined 0.1% last month alone.

Perhaps the Biden Administration should focus on helping everyday Americans afford Thanksgiving, rather than artificially imposing innovation-killing government price controls on lifesaving drugs, which are actually declining in price and nowhere near the inflation rate afflicting other consumer costs.

We at CFIF often warn how attempts at “drug price controls” will only succeed in killing lifesaving drug innovation, in which the U.S. leads the world without a close second.

Joe Biden’s so-called “Inflation Reduction Act” constitutes a perfect illustration, and in a Wall Street Journal piece entitled “The Inflation Reduction Act Is Already Killing Potential Cures,” USC Schaeffer Center for Health Policy & Economics fellow Joe Grogan shows how “we’re already getting signs of the damage”:

One poorly crafted provision is driving companies away from research into treating rare diseases.  In its Oct. 27 earnings statement, Alnylam announced it is suspending development of a treatment for Stargardt disease, a rare eye disorder, because of the company’s need ‘to evaluate impact of the Inflation Reduction Act.’  Alnylam’s decision turns on a provision in the Democrats’ bill that exempts from price-setting negotiations drugs that treat only one rare disease.  The company’s drug is currently marketed as treating only amyloidosis, and thus is exempt from Medicare’s price setting.  If Alnylam proceeded with research into treating Stargardt, it would lose its exemption.”

And that’s not even the end of it.  Earlier this week, Eli Lilly announced termination of a blood cancer drug because, “In light of the Inflation Reduction Act, this program no longer met our threshold for continued investment.”

Mr. Grogan proceeds to offer a must-read primer on how and why this is happening, then concludes by admonishing the next Congress convening in January to abandon this instant disaster and promote innovation instead of cheap Biden Administration talking point schemes:

The Democrats may have achieved a short-term talking point for the midterm elections, but in the long term this partisan healthcare bill will prevent patients from receiving innovative, lifesaving treatments.  A new Congress would serve Americans well by replacing the Inflation Reduction Act with an approach that recognizes the need for economic incentives to bring new treatments to patients.”

Good advice.

When pondering the origins of American Exceptionalism, and what makes us the most innovative, prosperous nation in human history, look first to our tradition of protecting intellectual property (IP) – patent, copyright, trademark, and trade secret property rights.

After all, other nations match or even exceed the U.S. in free market rankings (24 nations in the latest annual Index of Economic Freedom, in fact).  No nation, however, can match us for sheer innovation.  America accounts for less than 5% of the world’s population, and even with the world’s largest economy we account for under 25% of the global economy.  In contrast, no nation can match our scientific innovation, from flight to space exploration to the internet.  Nor can any nation match our artistic leadership, from the film industry to television to music, or claim as many instantly recognizable trademarks, from Coca-Cola to Apple.

Year after year, that’s why the U.S. leads global rankings of IP protection.

Perhaps most conspicuously, the U.S. accounts for fully two-thirds of all new lifesaving pharmaceuticals introduced to the world each year.  In an era increasingly reliant on pharmaceutical treatments for everything from Covid to cancer to Alzheimer’s, that is a leadership of which we should remain both proud and protective.

Inexplicably, however, some voices seek to undermine that IP leadership position.  A group called I-MAK offers the latest assault, with a “study” entitled “Overpatented, Overpriced,” which attempts to show “how excessive pharmaceutical patenting is extending monopolies and driving up drug prices.”  We employ scare quotes around the term “study” because I-MAK’s work has been previously debunked and exposed by leading IP scholars like George Mason University and Antonin Scalia Law School Professor Adam Mossoff and Senator Thom Tillis (R – North Carolina) for using defective and non-transparent supporting data.

Indeed, we highlighted earlier this year how drug prices have remained far, far below overall inflation.  Efforts like I-MAK’s would only end up suffocating drug innovation, not reducing prices, as we’ve also highlighted:

Of all new cancer drugs developed worldwide between 2011 and 2018, 96% were available to American consumers.  Meanwhile, only 56% of those drugs became available in Canada, 50% in Japan, and just 11% in Greece, as just three examples.  Patients in nations imposing drug price controls simply don’t receive access to new pharmaceuticals as quickly as Americans, if they ever receive them at all.”

Even the World Health Organization (WHO) acknowledges that overseas consumers’ lower access to pharmaceutical innovations stems from their governments’ imposition of price control regimes:

‘Every time one country demands a lower price, it leads to lower price reference used by other countries.  Such price controls, combined with the threat of market lockout or intellectual property infringement, prevent drug companies from charging market rates for their products, while delaying the availability of new cures to patients living in countries implementing those policies.’”

The irrefutable reality is that U.S. patent protections explain why we produce the overwhelming share of new drugs worldwide, including the Covid vaccines.  Efforts like I-MAK’s latest “study” continue a bizarre ongoing affront to property rights, the rule of law and IP.  If successful, they would only mean fewer future vaccines and treatments, and must be flatly rejected.

We at CFIF often highlight the clear and present danger that drug price control schemes pose to American consumers, who benefit from our private pharmaceutical sector that leads the world – by far – in innovation.  A new lung cancer treatment breakthrough in the form of Amgen’s Lumakras illustrates that interrelationship.

Simply put, Lumakras reduced the risk of progression by 34% compared to chemotherapy in patents with advanced lung cancer, which is particularly welcome considering lung cancer’s especially low survival rate (18.6% over five years, and just 5% for advanced forms).  The breakthrough required years of research and enormous amounts of investment, however, which The Wall Street Journal notes makes Lumakras the type of innovation put at risk by new drug price controls recently enacted by Congressional Democrats and the Biden Administration:

The drug is by no means a cure, but progress occurs at the margin and some patients who had what amounted to a death sentence now have hope to live.  Lumakras is also much less brutal than chemotherapy.

Yet the drug might not have been developed had the Medicare take-it-or-leave-it negotiations that Democrats recently enacted been in effect earlier.  Their price controls will penalize in particular small-molecule drugs like Lumakras that have the potential to help large numbers of patients.  Within six years, Lumakras could be targeted by bureaucrats for price controls and the payoff on Amgen’s investment could vanish.

The reason for that is simple.  Straightforward economic principles dictate the inevitable negative blowback from government price controls, whether in the form of 1970s gas lines here in the U.S. or food shortages in Venezuela.

Even the United Nations World Health Organization (WHO) warns explicitly about these negative consequences of price controls on drug innovation:

[P]rice controls, combined with the threat of market lockout or intellectual property infringement, prevent drug companies from charging market rates for their products, while delaying the availability of new cures to patients living in countries implementing those policies.  

Closer to home, a recent University of Chicago study quantified the destructive effect of drug price controls on future lifesaving innovations:

The United States has fewer restrictions on price than other countries, but the Biden Administration has announced their goal to lower drug prices through greater price regulation…  [N]ew drug approvals will fall by 32 to 65 approvals from 2021 to 2029 and 135 to 277 approvals from 2030 to 2039.  These significant drops in new drug approvals will lead to delays in needed drug therapies, resulting in worse health outcomes for patients.  

As the University of Chicago points out, the U.S. maintains a more market-oriented approach to pharmaceutical innovation than other developed nations, which benefits American consumers.  Of 270 new medicines introduced here in the U.S. since 2011, for instance, Canadians could only access 52% of them, the Germans 67%, the British 64%, the French 53%, the Japanese 48% and the Australians just 41%.  Moreover, the U.S. accounts for two-thirds of all new drugs introduced to the world.

The real-world numbers speak for themselves.  Americans benefit immensely from our world-leading pharmaceutical sector, and Lumakras offers just the latest welcome example.  The sooner the recent drug price control schemes are repealed or scaled back, the more Americans who suffer from cancer and other ailments stand to benefit.

As Senators Joe Manchin (D – West Virginia) and Kyrsten Sinema (D – Arizona) betray their “moderate” charade and join Senate Majority Leader Chuck Schumer’s (D – New York) latest tax-and-spend monstrosity, we’ve highlighted the preposterousness of the claim that imposing drug price controls will in any way address out-of-control inflation.  Price controls will kill innovation, but do nothing to reduce inflation, because prescription drug prices simply aren’t the problem.  Once again, economist Steve Moore offers a handy illustration of that truth:

Prescription Drug Costs Aren’t the Problem

For a man who constantly claims to support “Buy American,” Joe Biden demonstrates an inexplicable and almost fetish-like tendency to undercut American industries.

Since day one, the Biden Administration has ceaselessly besieged a domestic energy sector that finally achieved U.S. energy independence after decades of effort.  And now, it is following through on its inexcusably foolish assault against the U.S. pharmaceutical sector.

Each year, American pharmaceutical innovators account for an astounding two-thirds of all new lifesaving drugs introduced worldwide.  That’s the direct result of our system of intellectual property (IP) protections, including patents, which consistently leads the world.

Instead of protecting that legacy of American Exceptionalism, however, the Biden Administration remains bizarrely determined to eviscerate it.  Today, the World Trade Organization (WTO) announced agreement to forcibly waive patent protections for Covid vaccines, a dangerous effort that the Biden Administration for some reason supports.

This is nothing short of a license to steal U.S. patents.

The WTO effort serves no valid purpose, because Covid treatments are already being provided to poor nations across the world and the underlying pharmaceutical patents it targets are already being licensed at reduced prices or even for free.  Moreover, the  nations that the WTO claims to help recognize that lack of immunizations stems not from vaccine shortages, but rather from local logistical distribution problems and vaccination hesitancy among unvaccinated people in those nations.  Indeed, biopharmaceutical manufacturers remain capable of producing 20 billion vaccine doses this calendar year, so the problem isn’t lack of vaccine availability.

Additionally, a  supermajority of American voters spanning the political spectrum oppose this forcible waiver of Covid vaccine patents, favoring instead the licensing of patents to boost the global supply of vaccines.  Specifically, over 70% of voters believe that waiving Covid vaccine IP could have significant negative implications on the safety and efficacy of supply.

American patent protections explain our unmatched record of innovation, and also why we produce the overwhelming share of new drugs worldwide.  As the pandemic demonstrated once again, that includes Covid vaccines.  The WTO proposal egregiously sacrifices U.S. property rights and undermines the rule of law, which in turn will mean fewer lifesaving vaccines and treatments in the future.  If the Biden Administration won’t correct course, Congress must intervene to do so.

CFIF has continuously sounded the alarm on dangerous drug price control efforts, which will only do what artificial price controls always do – cause shortages of the very products they attempt to regulate.  The numbers speak for themselves.

Today, The Wall Street Journal editorial board cogently addresses the looming bankruptcy of Medicare and Social Security, and along the way nicely makes that point that we and others have been making, while also pointing out that drug prices have actually remained flat while prices for other products and services have skyrocketed:

Democrats blame Big Pharma for bankrupting Medicare, but annual Part D prescription drug costs have grown on average 1% over the last five years.  That’s far less than inflation, GDP and other Medicare spending. Even expensive drugs that grow spending in the short run can reduce long-term health spending.

Consider Hepatitis C treatments, which public-health scolds lambasted as too pricey when they launched nearly a decade ago.  Prices have since plummeted 75% from about $100,000 per course thanks to market competition.  A Department of Health and Human Services analysis estimates the treatments reduce patient health costs by about $16,000 annually and will save Medicaid $12 billion after this year.

Once the hospital trust fund runs dry, spending will have to be slashed by 10%.  The Democratic solution is to let Medicare “negotiate” drug prices — their euphemism for price controls.  But this will reduce the incentive to develop innovative treatments for hard-to-treat conditions like Alzheimer’s.  The result may be higher Medicare spending over the long term.“

Artificial government efforts to impose price controls never work, whatever the product, whatever the time and whatever the flimsy rationalization.  America leads the world in producing lifesaving pharmaceuticals – 2/3 of all new drugs introduced worldwide, in fact – so we mustn’t tolerate Biden Administration or Congressional efforts to try this failed proposal yet again.  The stakes for us all are too high to re-learn that lesson the hard way.

In our latest Liberty Update, we highlight an eye-opening new study confirming how drug price controls kill pharmaceutical investment and innovation at the worst possible time, when America and the entire world depend upon them more than ever.

In similar vein, American Enterprise Institute (AEI) Adjunct Fellow and healthcare expert Michael Rosen nicely illustrates how the omicron variant of Covid has paused the destructive global effort to suspend enforcement of patent rights belonging to lifesaving vaccine developers:

But the new omicron variant of the virus has intervened, shelving the planned WTO meeting and throwing into continued contrast the supposed haves and have-nots of vaccine protection…  But the EU has held firm in resisting the vaccine waiver, and rightly so.”

Unfortunately, even the EU remains too accommodating of calls to kill the goose that lays the golden vaccine eggs, but hopefully this latest experience brings greater collective wisdom.  If we seek to maximize healthcare and pharmaceutical innovation, the solution isn’t any secret.  Get bureaucrats and suffocating price controls and patent threats out of the way.

In the wake of this month’s catastrophic election results for Joe Biden and his party, many leftists stubbornly rationalized that voters were upset that Biden hadn’t seen more of his agenda passed, and that the answer to Biden’s and Democrats’ ills was to step on the gas and pass more of that agenda.  Well, the new ABC News/Washington Post poll offers and instant rebuttal.  The survey is nothing short of catastrophic for Biden and Democrats as 2022 approaches, with Republicans scoring record preferences (see image below).  But note something else:  This poll was conducted November 7 – 10, AFTER Biden’s “infrastructure” spending bill was passed.

“Build Back Better” Is a Loser

We at CFIF have detailed the catastrophic potential effects of passing Biden’s even larger spending bill currently before Congress, including its potentially devastating consequences for American healthcare and pharmaceutical innovation:

Specifically, they’re attempting to cement agreement on provisions that would empower the federal government to begin “negotiating” drug prices with manufacturers and imposing draconian penalties upon providers that don’t play ball.

That constitutes a scheme to bring price controls to American healthcare, with catastrophic effects, according to analyses from both the non-partisan Congressional Budget Office (CBO) as well as the University of Chicago.”

This new ABC News/Washington Post poll should offer a cautionary tale for Senators Joe Manchin (D – West Virginia), Kirsten Sinema (D – Arizona) or anyone else even contemplating voting for it.

In this week’s Liberty Update we highlight the potentially catastrophic threat of H.R. 3, the healthcare and drug price control bill that Joe Biden and Nancy Pelosi are attempting to rush through Congress.  The Wall Street Journal helpfully offers further insight this morning on how H.R. 3 would threaten lifesaving U.S. pharmaceutical innovation and leadership, including on things like the Covid vaccines:

Companies that refuse the government’s price must pay a 95% excise tax on all revenue they generate from that drug in the U.S.  They’d also have to offer the government price to private insurers.  There’s no “negotiation” when a gun is pointed at your head.  A new study in the Journal of the American Medical Association estimates that drug spending in the U.S. would have been 52%, or about $83.5 billion, lower in 2020 based on the bill’s formula.  The research outfit Vital Transformation estimates the bill would reduce bio-pharmaceutical earnings by $102 billion a year…

The hugely successful mRNA Covid vaccines are the result of years and billions of dollars in research.  BioNTech initially set out to create cancer vaccines and linked up with Pfizer in 2018 to work on a more effective flu vaccine.  Biotech firms are trying to use mRNA technology for personalized cancer vaccines, autoimmune treatments and gene therapies.”

Americans cannot allow Biden, Pelosi and Schumer to jeopardize our future health on behalf of their hyper-partisan agenda.