In recent days, we at CFIF have marked the ignominious one-year anniversary of the Biden Administration…
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Drug Price Controls: On 9/13, Let's End the Indefensible 9-13 Small Molecule/Large Molecule Protection Disparity

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…[more]

September 13, 2023 • 03:24 PM

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Biden Drug Price Controls Threaten Alzheimer’s Breakthroughs Print
By Timothy H. Lee
Thursday, March 09 2023
Biden wants Americans to believe that he’s offering pain-free drug price reductions, when the primary effect of his policies will be eliminating access to lifesaving drugs.

For years, we’ve hoped in vain for Alzheimer’s disease treatments that improve survival rates or quality of life as witnessed with so many other diseases.  

We now have two promising breakthrough treatments, but due to the Biden Administration’s agenda of socialized medicine and drug price controls, millions of Alzheimer’s victims may be denied access to them.  

Of course, that’s always the effect of price controls throughout history and across every type of product or service.  

Price controls never simply reduce consumer prices without any downside.  They necessarily reduce supply or eliminate it altogether, and the new Alzheimer’s treatments offer the latest textbook illustration.  

While it may be futile to expect Joe Biden to internalize that immutable law of economics, that doesn’t mean that the rest of America whose lives and wellbeing are put at risk by his agenda should passively accept it.  

By way of background, in late 2020 the Food and Drug Administration (FDA) – the federal agency whose mission is to oversee drug effectiveness and safety – approved Aduhelm (also known as Aducanumab) to treat Alzheimer’s patients after testing showed that it removed 71% of plaque buildup and reduced cognitive decline between 25% and 28%:  

Today, the U.S. Food and Drug Administration approved Aduhelm (Aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans.  Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. …  

Aduhelm represents a first-of-its-kind treatment approved for Alzheimer’s disease. It is the first new treatment approved for Alzheimer’s since 2003, and is the first therapy that targets the fundamental pathophysiology of the disease.  Researchers evaluated Aduhelm’s efficacy in three separate studies representing a total of 3,482 patients. The studies consisted of double-blind, randomized, placebo-controlled dose-ranging studies in patients with Alzheimer’s disease.  Patients receiving the treatment had significant dose- and-time-dependent reduction of amyloid beta plaque, while patients in the control arm of the studies had no reduction of amyloid beta plaque.  

On January 6 of this year, the FDA also approved the new drug Leqembi to treat Alzheimer’s after finding that, “Patients receiving the treatment had significant dose- and time-dependent reduction of amyloid beta plaque, with patients receiving the approved dose of lecanemab, 10 milligram/kilogram every two weeks, having statistically significant reduction in brain amyloid plaque from baseline to Week 79 compared to the placebo arm, which had no reduction of amyloid beta plaque.”  

Accordingly, the FDA has approved two novel treatments for Alzheimer’s as safe and effective, providing hope to patients and loved ones desperate for help.  

The political left, however, immediately objected on the basis of cost even after Biogen reduced the price of Aduhelm by half.  

Then the Centers for Medicare and Medicaid Services (CMS) intervened.  In contrast to the FDA, CMS is the federal agency tasked with administering Medicare and Medicaid programs in conjunction with state and local governments.  It nevertheless ventured beyond its realm of expertise by curtailing coverage for the treatments despite their demonstrated improved health outcomes.  

The underlying reason for all of this is obvious.  Biden is set to unveil his plan to “save” Medicare from insolvency through a mixture of tax increases and drug rationing to slash costs, and new treatments like Aduhelm and Leqembi must be sacrificed due to their inconvenient costs.  Tough luck, Alzheimer’s victims.  

The Alzheimer’s Association was understandably blistering in its reaction:  

The Alzheimer’s Association is appalled that the Biden Administration is extending its unjust decision to deny access to FDA-approved treatments for people living with Alzheimer’s – a fatal disease. … “CMS’s role is to provide health care coverage.  Their role is not to stand between a patient and doctor when deciding what FDA-approved treatments are appropriate. Their role is not to single out people living with Alzheimer’s and decide that their lives, their independence and their memories are not necessary,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO. …  

The Alzheimer’s Association estimates that each day CMS leaves this misguided policy in place, more than 2,000 individuals aged 65 and older may transition from mild dementia due to Alzheimer’s to a more advanced stage of the disease where they are no longer eligible for the new FDA-approved treatments. Treatments taken in the early stages of Alzheimer’s would allow people more time to participate in daily life, remain independent and make health care decisions for their future.  

A rare bipartisan coalition in both the Senate and the House coalesced in opposition to the Biden Administration’s decision as well.  They shouldn’t be surprised, however.  This is the inevitable result of drug price controls and socialized medicine.  

Biden wants Americans to believe that he’s offering pain-free drug price reductions, when the primary effect of his policies will be eliminating access to lifesaving drugs.  If a private business attempted that sort of duplicity, the full weight of government prosecution would be brought to bear.  

Congress and the American electorate should be equally forceful in their opposition to this Biden Administration injustice.  

Notable Quote   
"You would think that an attorney general who has presided over the embarrassing debacle of the Hunter Biden investigation would express contrition, or maybe a little anger at the underlings who have shamed him, when he is hauled before a congressional committee to explain his failures.But alas, Merrick Garland is just another Mr. Magoo.His department is ablaze but he knows nothing.The nation's chief…[more]
— Miranda Devine, New York Post Columnist
Liberty Poll   

In your opinion, how likely is a federal government shutdown at the end of September, based on budgetary and other disagreements in the fractured House of Representatives?