The Current FDA Situation: AbbVie, the FDA, and Natural Desiccated Thyroid Drugs
Back in 2009, patients taking natural desiccated thyroid (NDT) drugs struggled through an unprecedented FDA "crackdown" on NDT. Some of the brand and generic versions of NDT drugs started to disappear off the shelves. At the same time, the FDA was ramping up its ominous threats to force all “grandfathered” drugs -- drugs that never went through the new drug application (NDA) process -- to get formal FDA approval. (Grandfathered drugs were on the market before the FDA started approving drugs. Because these drugs were deemed essential, they were never taken off the market and/or forced to go through an approval process. They are considered FDA-regulated, but not "FDA-approved,” and remain legal to prescribe.)
At that time, there were strong indications that the FDA planned to pull ALL NDT drugs off the market, and force them to go through the lengthy – and, in some cases, prohibitively expensive –process of filing an NDA.
Patients were NOT happy, to say the least, and we created a vocal grassroots activist movement -- "Save Natural Thyroid' -- to make it clear to the FDA that we were not going to be quiet if they went forward to take action against an entire category of medication that millions of patients relied on daily for their hypothyroidism. The FDA backed down, and shelved their plans for NDT drugs…for the time being.
But in 2020, more than a decade later, the FDA was back at it again, with plans that put millions of thyroid patients at risk.
What happened was that in early 2020, for some unexplained reason, the FDA dramatically ramped up targeted inspections of selected NDT manufacturing facilities. In May of 2020, Acella, the small drug company that manufactures NP Thyroid, ended up doing a voluntary recall of 13 lots of their NP Thyroid tablets, because the stated dosage, and specifically, the extra potency was coming from the T3. Some patients had become hyperthyroid, and reported adverse effects, including symptoms of overmedication such as rapid heartrate. Acella was, however, allowed to continue distribution of the lots not listed by the FDA.
In September 2020, Acella did another FDA-prompted voluntary recall, this time for sub-potency. Again, Acella was allowed to continue marketing the lots of medication that apparently were not affected.
Also in September, RLC Labs – the small company that manufactures WP Thyroid and Nature-throid -- voluntarily recalled 483 lots of their drugs, due to FDA allegations of a minor sub-potency in only 6 lots.
The word on the street is that there had been no patient reports of any adverse effects, as the sub-potency in RLC’s products affected only a small number of batches, and the variation was a tiny fraction off of the required T4 level.
Were all these recalled lots sub-potent? Highly unlikely. The FDA could have given RLC an up-front opportunity to test specific lots in time to avoid a broad recall, as they did for Acella. But that didn’t happen. It appeared that the FDA may have threatened to strong-arm RLC with an involuntary recall – the kiss of death in the pharma world. In order to stay in business, RLC may have been forced to comply. So, thanks to the FDA, all the available stock of WP Thyroid and Nature-throid got pulled out of distribution – making it unavailable to the patients who depend on it.
Late in 2020, some limited stock of NP Thyroid was made available, but Nature-Throid and WP Thyroid remained off the market into 2021, with no specific return date.
The Biologics Controversy
At the same time that the FDA was cracking down on Acella and RLC, they also included an ominous new requirement in their warning letters to both companies. The FDA indicated that they were now defining NDT drugs as "biologics." Here is an excerpt from those letters.
Biologics are defined as biopharmaceuticals, treatments manufactured by synthesizing genetically-engineered proteins in living cells. You've probably heard of other "biologics," like Botox, Humira, and Enbrel. Biologics are relatively new to the market. In order to be approved by the FDA, biologics have to go through a rigorous, expanded, very lengthy -- and very expensive -- FDA approvals process that is far more complicated than even a standard new drug application.
On the other hand, NDT is a drug, derived from natural sources, and the manufacturing process involves no genetic engineering, no protein synthesis, and no living cells. NDT has been on the market for more than 100 years, and has been used safely by millions of patients for more than a century. By most definitions, NDT isn’t even close to fitting the definition of a biologic drug.
The question, then is this: Why is the FDA designating NDT as a biologic now?
The NDT Market Competition
There are three companies making NDT drugs in the U.S.:
Acella, which makes NP Thyroid, has less than 200 employees, and around $120 million in annual revenue.
RLC, which makes WP Thyroid and Nature-throid, has less than 50 employees, and around $30 million in annual revenue
AbbVie, which makes the best-known brand of NDT Armour Thyroid, employs about 30,000 people in 75 countries, and has annual revenue of around $30 billion -- yes, billion -- a year. This global pharma behemoth also has huge armies of drug reps, marketing teams, and lobbyists on staff. Note that AbbVie only recently acquired Allergan – and Armour.
In addition to Armour Thyroid, AbbVie also manufactures the best-known brand of levothyroxine: Synthroid. And AbbVie ALSO holds the rights to make and market Thyrolar (liotrix), a synthetic T4/T3 drug with a T4/T3 ratio similar to NDT. Thyrolar is not currently being manufactured or on the market, but it could be at any time if AbbVie chose to start back up. (Disclosure: Years ago, I took Thyrolar, and it worked well for me. I switched to NDT after Thyrolar stopped production.)
The only category of thyroid hormone replacement AbbVie is not publicly involved in? Synthetic T3 (liothyronine). The brand name Cytomel is made by Pfizer, and there is also a generic version of liothyronine. (Does AbbVie have a T3 drug in the pipeline? I wouldn't be surprised if they do.)
An important point: AbbVie’s Synthroid brand levothyroxine has the highest retail price of any brand-name levothyroxine tablet. Their Armour Thyroid NDT drug has the highest retail price of any natural desiccated thyroid drug. AbbVie’s two thyroid drugs, in fact, frequently have a retail price that is more than double other brand names.
Into this environment, we have the FDA intensively cracking down on only the two small companies, and requiring voluntary recalls of their NDT drugs – but AbbVie is being left alone. Why?
AND, at the same time, we have the FDA – seemingly out of the blue -- making a surprise announcement to apply a new “biologics” designation to a safe and effective 100-year old drug that does not fit the definition of a biologic. And this controversial decision by the FDA will effectively put AbbVie’s competitors out of the NDT business for good. Again, why?
Why? Follow the Money!
Why is the FDA cracking down on Acella and RLC, but NOT AbbVie? Why did the FDA suddenly decide to categories a 100-year-old drug as a “biologic?”
My theory: FOLLOW THE MONEY!
In order to get FDA approval as a biologic, Armour needs to go through a lengthy process, including intensive review by FDA committees. AbbVie already makes a number of “biologics,” including Humira, Creon, and a number of other drugs that are legitimately classified as biologics. As a result, AbbVie– unlike Acella and RLC – has teams of lawyers, scientists, and lobbyists already in place to go through the biologic drug approval process. Reportedly, as of February 2020, AbbVie is already doing the extensive lobbying, testing, studies, and paperwork involved in getting biologics approval for Armour.
And make no mistake: there’s money to be made all around during an approvals process.
First, there’s actually an established pipeline of payments that go from big pharma companies to the FDA advisory and regulatory committees with the authority to grant approvals. Science Magazine is one of many sources that have documented conflicts of interest between FDA advisors, who receive payments from big pharma companies before, during, and after drug reviews and approvals. Many FDA advisors stand to profit from NDT going through the approval process for biologic designation.
Second, not a day goes by that AbbVie lobbyists aren’t walking the halls of the FDA, and in contact with FDA decision makers. AbbVie even has its own political action committee – AbbVie PAC – which has donated almost $1.5 million to candidates during the 2020 election cycle. The lobbyists, lawyers, and other experts are well-compensated for an FDA approval process.
Third, even the FDA can get in on the windfall. Pharma companies sell each other “vouchers” that allow them to speed up the FDA approvals process. Back in 2015, AbbVie paid another pharma company a record $350 million for a voucher that let them cut time off the FDA review process for a new drug. So the FDA itself stands to potentially benefit financially from NDT going through a sped-up approval process for biologic designation.
Finally, AbbVie itself stands to profit greatly as well. I predict that Armour Thyroid will quickly sail through the FDA process, and get formal approval as a “biologic” thyroid hormone replacement drug. At that point, Acella and RLC will be legally unable to sell their NDT drugs, leaving AbbVie with a complete monopoly on the NDT tablet market. Armour Thyroid will be the only NDT, and millions of thyroid patients will no longer be able to get the Nature-Throid, WP Thyroid, and NP Thyroid they have been taking. If they want to stay on NDT, the only option will be Armour, at whatever price AbbVie decides to charge.
Armour Thyroid is already around double the price of its competitors, including its FDA-designed equivalent generic, NP Thyroid. What will Armour cost after it has FDA approval as a biologic? Keep in mind that all "biologics" currently on the market are very expensive. The retail price for Botox runs about $500 to $800 per treatment. Enbrel is around $5,000 a month. AbbVie’s Creon runs about $1,700 a month.
And the average monthly cost for AbbVie’s Humira is around $7,000…a MONTH! Insurance copays for these biologic drugs can also be extremely high and prohibitively expensive for many patients. (And that’s assuming the insurance company will even cover these drugs. Some do not, forcing many patients to take other medications that are less expensive, and far less effective.)
It’s a pretty safe bet to assume that Armour will cost more than its $100 a month average retail price currently listed at GoodRx. After biologic designation, AbbVie may – and probably will -- charge hundreds or even thousands of dollars a month for Armour Thyroid.
THE BOTTOM LINE: To me, it appears that AbbVie – seemingly with help from the FDA – has set the stage for a highly profitable total monopoly on NDT drugs, and with that monopoly, they will also be able to charge whatever price they want for Armour.
What’s Right for Patients?
Where do patients figure into this scenario? Sadly, we don’t!
Some patients do well on Armour, others do best on Nature-Throid, WP Thyroid, or NP Thyroid. How well you personally do on a particular NDT drug depends on how it’s formulated, and the excipients, coatings, and disintegrants it uses. Thyroid treatment is NOT one-size-fits-all.
The FDA crackdown and the biologics designation, however, seem designed to make NDT treatment a one-size-fits-all treatment. Neither effort is focused on providing better or affordable hypothyroidism care!
It’s clear, when you consider these questions:
Is it in the best interests of people with hypothyroidism for the FDA to selectively target and force recalls from only the small manufacturers making affordable NDT? NO!
Is it in the best interests of people with hypothyroidism for the FDA to effectively hand AbbVie a total monopoly on NDT drugs, ensuring that patients can’t get the Nature-Throid, WP Thyroid, and NP Thyroid that works best for them? NO!
Is it in the best interest of people with hypothyroidism to reclassify a safe, effective, 100+-year-old drug as a “biologic,” a scientifically-questionable forcing most NDT drugs to go off the market? NO!
Is it in the best interest of people with hypothyroidism who don’t respond well to Armour to force them to stop taking Nature-Throid, WP Thyroid, and NP Thyroid, if those are the drugs that have proven to best and safely manage their thyroid condition and resolve their symptoms? NO!
Many insurance companies -- and Medicare -- don't even cover Armour now. Is it in the best interest of people with hypothyroidism to force them to pay higher copays or significantly higher cash prices for the “new Armour Thyroid” – or be unable to afford Armour at all, and end up forced to take other medications that don’t work well for them? NO!
Frankly, NONE of this makes ANY sense for thyroid patients. It only makes sense – financial sense -- for AbbVie, the FDA, lawyers, advisors, and pharmacies. Patient interests are clearly irrelevant!
What Can You Do?
As a patient advocate, I firmly believe that patients deserve to be able to affordably take any thyroid medication safely and best resolves their symptoms.
I also have a personal interest in ensuring that ALL the NDT options remain on the market and affordable. I feel best on the WP Thyroid. With no coatings, and all-natural excipients, I have the best absorption and control on WP Thyroid.
Unfortunately, since fall 2020, we have been unable to get some dosages of NP Thyroid, and WP Thyroid and Nature-throid have been totally unavailable! As a result, many patients – myself included – have already been forced to take NDT brands that don’t work for us, and pay higher prices to boot! (In my case, just six weeks after switching from WP Thyroid to NP Thyroid at the same dose, my TSH level rose almost 3 points, and I had a major relapse of symptoms!)
Make no mistake. This situation is a MAJOR crisis for thyroid patients taking NDT!
We have to speak up NOW -- loudly and consistently -- to protect our right to take the natural desiccated thyroid drug of our choice. If we don’t, we will soon end up with Armour Thyroid as the only NDT drug, at potentially unaffordable prices.
If you want to protect your right to take the NDT of your choice, here’s what you can do.
1. Contact the FDA!
Start by contacting the following people at the FDA:
Dr. Shawn Larson at 214-253-5216, email Shawn.Larson@fda.hhs.gov
William Millar at (503) 671-9711 Ext. 30, email firstname.lastname@example.org
Tamala Bogan, email Tamala.email@example.com
Steven Porter, Jr., email firstname.lastname@example.org
Note: Be sure to CC all emails to ORAPHARM2_Responses@fda.hhs.gov
You should also call and complain to the FDA main consumer line at 1-888-INFO-FDA (1-888-463-6332)
Finally, contact the FDA Consumer Complaint Division for your region: https://www.fda.gov/safety/report-problem-fda/consumer-complaint-coordinators
2. Report Your Adverse Effects
If the NDT recalls have forced you to take a thyroid drug that doesn't work for you and you have any adverse effects, be sure to report them to the FDA…EVERY SINGLE TIME! You should report them to the FDA’s Medwatch System for Adverse Effects, online at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
3. Flood the FDA on Social Media!
Don’t forget to FLOOD the FDA on social media to express your concerns. NDT drugs have been prescribed safely for a century, and are an effective and affordable treatment option for millions of people with hypothyroidism.