Douglas – stock.adobe.com
The clock is ticking: In two weeks, millions of Americans could lose access to the affordable medication that’s helping them lose weight and improve their health.
I should know — I’m one of them.
In the final weeks of his administration, President Biden’s Food and Drug Administration quietly ended the “shortage” of tirzepatide, a popular GLP-1 medication.
That means on March 19, safe, lower-cost alternatives will be removed from the market — and Big Pharma’s profits will skyrocket.
When Dr. Marty Makary, President Trump’s nominee as FDA commissioner, sits down Thursday for his confirmation hearing before the Senate Health, Education, Labor and Pensions Committee, this crisis deserves to be on the agenda.
Ending a shortage sounds like a good thing, so how exactly can this decision harm Americans?
First, understand that Biden’s unilateral decree did nothing to change reality: The shortage of tirzepatide, which has zoomed in popularity in the last two years, still exists.
But without government acknowledgment of that fact, pharmacies will no longer be permitted to sell alternative, lower-cost compounded versions of the medication — and costs to consumers will soar.
Patients who today can get the drug compounded for $350 a month will have no option but to pay $1,000 a month for Mounjaro or Zepbound, the Big Pharma name-brand versions that insurance usually won’t cover — if they can find it, that is.
Simply put, tirzepatide will become unaffordable overnight for many who rely on it.
GLP-1 medications like tirzepatide — one of several drugs that mimics our natural GLP-1 hormone, helping patients feel fuller and eat less — have become a cornerstone of health management for millions of Americans.
When used under the care of a physician and paired with lifestyle changes, these drugs have revolutionized both weight loss and the treatment of chronic conditions.
Trust me, I speak from personal experience.
Over the years, I’ve tried every weight loss drug, from Fen-Phen to Contrave and Qsymia, but GLP-1s have truly been a game changer for me.
The end of the tirzepatide “shortage” is not isolated: In February, a Biden administration holdover at the FDA declared an end to the shortage of another GLP-1 medication, semaglutides like Ozempic and Wegovy — imposing looming deadlines on compounded versions of those products as well.
Increasing access to life-changing medications should be our government’s priority. So why did the Biden administration put the profits of Big Pharma over the well-being of millions of Americans?
Biden’s decision to sell us out will have a significant impact. More than 12% of US adults have used GLP-1 drugs to manage chronic conditions including diabetes, heart disease and obesity.
A tripling of their costs will be devastating to those who have come to rely on it.
Many people using GLP-1s are at high risk of developing serious cardiovascular and metabolic diseases without the medication. Yet insurance companies only cover the costs in limited circumstances.
This pushes patients into paying incredibly high out-of-pocket costs — leaving many with no safe alternatives, should legitimate compounding pharmacies be forbidden from making off-brand versions.
In fact, recent data has revealed that if tirzepatide becomes unaffordable, millions of Americans may turn to unregulated sources instead.
An internal poll conducted by Ivim Health found that 85% of GLP-1 users would turn to black-market alternatives for their medications if the price became prohibitive.
And while Americans would compromise their health, Big Pharma would continue raking in profits.
The United States is grappling with an obesity crisis. By eliminating affordable access to revolutionary treatments, we miss the chance to reduce risk for conditions like heart disease, diabetes, hypertension, respiratory disorders and more — conditions that can lead to life-altering disabilities.
If their medications are suddenly removed, research shows, patients who benefited from GLP-1 therapy will face both weight regain and increased risk of heart attacks, strokes and other major cardiovascular events — all due to the FDA’s rushed decision.
Americans cannot and should not tolerate our government prioritizing corporate profits at the expense of our health.
And this is about more than just one class of drugs: It showcases the concerning reality that the FDA has continued to allow corporate interests to take the upper hand in our health care.
President Trump’s FDA needs to correct course, and quickly. Without urgent action, on March 19 Americans are going to pay the price.
Sean Spicer, who served as the 30th White House press secretary, hosts the Sean Spicer Show podcast.