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Posts Tagged ‘Drug Price Controls’
September 13th, 2023 at 1:18 pm
Drug Price Controls: On 9/13, Let’s End the Indefensible 9-13 Small Molecule/Large Molecule Protection Disparity
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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.

 

August 25th, 2023 at 11:23 am
Innovation Killer: Biden Administration to Announce Ten Lifesaving Drugs Subject to Destructive “Bidenomics” Price Controls
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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.

 

November 17th, 2022 at 11:48 am
Stat of the Day: Thanksgiving Costs Up a Record 20%, but Prescription Drug Prices Decline
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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.

September 22nd, 2022 at 4:58 pm
New Lung Cancer Breakthrough Illustrates the Potential Peril of Drug Price Controls
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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.

 

June 6th, 2022 at 12:49 pm
Drug Costs Remain Far Below Inflation, but Beware Efforts to Impose Socialist “Price Controls”
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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.

July 24th, 2020 at 4:10 pm
CFIF Opposes White House Executive Order Importing Foreign Nations’ Socialized Medicine and Drug Price Controls
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Regrettably, the White House today announced an executive order that effectively imports drug price controls from foreign nations with socialized healthcare systems.  We at CFIF strongly oppose the order and encourage immediate reconsideration.  Below is CFIF President Jeffrey Mazzella’s statement:

“Price controls simply do not work, regardless of the product targeted or the location they’re attempted, and real-world experience establishes that pharmaceutical price controls are no different.  The new executive order would impose what’s known as an International Pricing Index (IPI) for U.S. drugs administered by the federal government, meaning that foreign governments’ drug price controls would suddenly control our own reimbursement rates.  That would upend our current system, which has actually already reduced the cost of the 50 most popular Medicare Part B drugs sold by approximately 1%.  Our current system already includes the discounts negotiated between hospitals, healthcare plans and payers.  In contrast, foreign governments whose price control schemes we would import don’t negotiate, but instead dictate prices while threatening to violate patent rights and employ a ‘take it or leave it’ approach.

“As a direct consequence of foreign nations’ price control approaches that disrespect patent rights, those nations receive far fewer new lifesaving and life-improving drugs than American consumers.  For example, 96% of all new cancer drugs over the past decade were made available to U.S. consumers.  In contrast, only 56% of those same drugs became available in Canada, only 50% became available in Japan and only 11% in Greece, as just three examples.  Simply put, consumers in nations whose governments impose drug price controls don’t enjoy access to nearly as many new drugs as Americans, or nearly as soon.  As The Wall Street Journal found, that’s why America outpaces European nations in terms of cancer survival rates, among other advantages.

“Even the Trump Administration itself has highlighted the destructive effect of importing foreign price controls.  In 2018, its Council of Economic Advisers affirmed that, “If the United States had adopted the centralized drug pricing policy in other developed nations twenty years ago, then the world may not have highly valuable treatments for diseases that required significant investment.”

“Currently, the United States accounts for nearly two-thirds of all new drugs introduced worldwide, and our more market-oriented system and protection of patent rights explains why.  Very few potential new drugs ever reach the market, due to astronomical research and development costs, lengthy government safety tests, laboratory effectiveness trials, possible product liability lawsuits, patent protection limitations and other bureaucratic hassles.  Imposing artificial price controls would add to those headwinds by making it less possible to recover the massive costs of developing new medicines and R&D, leading to fewer new drugs for U.S. consumers.

“Instead of importing foreign nations’ price control schemes and their consequences, America should be exporting our superior system to their shores.

“Today’s executive order contravenes the Trump Administration’s broader agenda of deregulation, free-market approaches and strong intellectual property (IP) protections.  Hopefully, the White House quickly realizes the potentially catastrophic consequences of this order, lest American consumers suffer in the same way as consumers in the foreign nations that impose the price controls that it now seeks to import.

“In his State of the Union Address earlier this year, President Trump reassured Americans that, ‘To those watching at home tonight, I want you to know that we will never let socialism destroy American healthcare.’  Unfortunately, the White House’s executive order announced today regarding drug prices would do precisely that.

“We therefore urge President Trump to reconsider this potentially catastrophic order in the strongest possible terms.”

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February 24th, 2020 at 4:44 pm
Sen. McSally Must Avoid the Trap of Counterproductive Prescription Drug Legislation
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Senator Martha McSally (R – Arizona) has broadly proven herself a stalwart ally of conservatives, libertarians and the Trump Administration in her brief tenure on Capitol Hill.  A former U.S. Air Force A-10 pilot, her votes have confirmed President Trump’s phenomenal array of judicial nominees and advanced his economic agenda to bring us arguably the greatest economic conditions in history.

She must be careful, however, to avoid potentially catastrophic missteps on the issue of healthcare and prescription drugs.

Specifically, Sen. McSally has introduced legislation and supported other Senate Finance Committee proposals that would introduce drug price controls from socialist foreign healthcare systems to the U.S., empower the Department of Health and Human  Services (HHS) to directly and bureaucratically negotiate pharmaceutical prices, allow importation of potentially dangerous drugs from foreign countries and introduce components that would erode our world-leading patent system.

It’s not by accident that the U.S. accounts for over two-thirds of all new lifesaving and life-improving pharmaceuticals introduced to the world – it’s the direct result of our strong patent protections here, and our more market-oriented approach.  In contrast, foreign nations that have introduced the principles contained in some of Sen. McSally’s legislation and bills that she supports inevitably suffer shortages, as even the United Nations World Health Organization (WHO) has acknowledged:

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.

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 the Canda, 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.

Senator McSally mustn’t sacrifice her conservative principles on behalf of prescription drug legislation that will make matters worse for American consumers, not better.  She should withdraw her proposed bill and renounce the Senate Finance Committee’s proposal, and instead support more market-based solutions that have proven effective not only with pharmaceuticals, but across all economic realms.