What’s REALLY Going on With the FDA and Natural Desiccated Thyroid Drugs?

Back in 2009, those of you who were taking natural desiccated thyroid (NDT) drugs for hypothyroidism probably remember the FDA “crackdown” that year. Some of the 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 “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, it also looked and sounded like the FDA might actually 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 here we are again, more than a decade later, and it’s looking like the FDA is back at it again, with plans to put thyroid patients at risk.

In early 2020, for some unexplained reason, the FDA dramatically ramped up its inspections of selected NDT manufacturing facilities. In May, 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 FDA found they were super-potent. That means that these lots of NDT were MORE potent than 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, 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.

In early September, RLC Labs — another small company that manufactures two NDT drugs — WP Thyroid and Nature-throid — voluntarily recalled 483 lots of these 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 was just a tiny fraction off of the required T4 level. The bigger question: Were 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. My sense is 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 — until new product can be manufactured and tested, which is likely to take several months.

Now, here’s something else you may not be aware of. The FDA letters to Acella and RLC also indicated that the FDA intends to change the designation of NDT drugs to define them as “biologics.”

Excerpt from FDA warning letter

Biologics are drugs that are derived from living cells. You’ve probably heard of other “biologics,” like Botox, Humira, and Enbrel. I’ll explain what this means in a moment.

I Have Questions!

So, here’s the situation. There are three companies making NDT drugs in the U.S.: two are, as noted, small companies:

• 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 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.

And, as I mentioned, there is so much going on here, and I HAVE QUESTIONS!

My first question: Why is the FDA so interested in and cracking down on Acella and RLC, but NOT AbbVie?

And second: Given that NDT has been on the market for more than 100 years, and is being used safely by millions of patients, why would the FDA make such a major change in how NDT drugs are categorized, and only now designate them as “biologics?”

These are important questions, and to date, we don’t have definitive answers. But I have my own theories…

In addition to Armour Thyroid — the best-known brand of NDT — 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. 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 synthetic combo, with a T4/T3 ratio similar to NDT, worked well for me.)

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. (But who knows what AbbVie may have in the pipeline? I wouldn’t be surprised if they have a branded liothyronine in the pipeline, along with plans to resurrect Thyrolar, not to mention other thyroid meds in the works.)

Now let’s talk price. Synthroid has the highest retail price of any brand-name levothyroxine tablet. Armour Thyroid 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.

My Theory: FOLLOW THE MONEY!

So why is the FDA interested in, or cracking down on Acella and RLC, but NOT AbbVie?

FOLLOW THE MONEY.

There’s an established pipeline of payments that go from pharma companies to FDA advisory and regulatory committees. 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.

Smaller pharmaceutical companies like Acella and RLC simply don’t have deep enough pockets to be able to spread around that kind of money to FDA advisors.

Also, 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.

As you would expect, small pharma companies don’t have big teams of lobbyists.

And did you know that pharma companies even 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 where am I going with this? Well, given that millions of people take natural thyroid drugs, are you surprised that the two companies that make the far less expensive NDT drugs — and can’t afford lobbying, FDA advisor payments, and political donations — are apparently under siege by the FDA and having their products pulled off the market? Meanwhile, the pharma giant with the deep pockets — the one with the most expensive thyroid drugs — appears to be getting a pass.

AbbVie is in an enviable position. If the FDA officially declares NDT a “new drug,” all the NDT drugs will have to go through the new drug application (NDA) approvals process. At the same time, during the NDA process, the FDA may:

1. require NDT drugs to go OFF the market entirely; or

2. allow NDT drugs to stay ON the market.

Option 1 would force millions of patients off NDT entirely, leaving them with only levothyroxine drugs for hypothyroidism treatment. (And of course, many patients would end up taking AbbVie’s Synthroid. AbbVie would still be selling medication to thyroid patients — even as some of those patients suffer on a medication that doesn’t work for them.)

If the FDA went with Option 2, let’s face it. The reality is that Acella and RLC are already under targeted scrutiny by the FDA, and dealing with their recalls. Trying to both replace recalled product supply, and manage a costly NDA process could potentially force them out of the market entirely. AbbVie, on the other hand, has not only been spared any recalls and FDA strong-arming, but also has more than enough resources on hand to easily sail through the NDA process for Armour Thyroid. The result? Armour could easily end up the ONLY NDT on the market.

I have to wonder if AbbVie is positioning itself to have a complete monopoly on the NDT market, and a near monopoly on thyroid treatment in general. And I also have to wonder: Is the FDA actually helping them?!

And, if AbbVie succeeds at creating a monopoly, how much will the already high prices of both Armour Thyroid and Nature-throid increase? My guess is that prices will rise astronomically!

The Biologics Issue

Now, let’s talk about the issue of biologics. As I said, NDT has been on the market for more than 100 years, and used safely by millions of patients. So why designate this medication as a biologic now?

Again, FOLLOW THE MONEY. In order to be approved by the FDA, biologics have to go through an even more rigorous, expanded, lengthy — and very expensive — FDA approvals process that makes a standard NDA look like a breeze.

Guess who already makes a number of “biologics,” and has the teams of lawyers, scientists, and lobbyists already in place to get a biologic drug approved? You guessed it. That would be AbbVie. AbbVie makes Humira, Creon, and a number of other biologic drugs.

Guess who doesn’t? That would be Acella and RLC.

And here’s the kicker. “Biologics” are very expensive drugs. 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!

That leaves me with more questions: Whose idea was it to designate NDT as a “biologic?”

And, if the FDA goes forward with its plan to designate NDT as a biologic, what’s likely to happen?

My guess? Armour Thyroid will sail through the FDA process, and get formal approval for Armour Thyroid as a “biologic” thyroid hormone replacement drug. And what do you think AbbVie is going to charge for it? It’s a pretty sure bet that it’s going to cost a LOT more than the $100 a month average retail price for Armour currently listed at GoodRx. It could be hundreds — or even thousands — of dollars a month. Many insurance companies — and Medicare — don’t even cover Armour now. Who thinks it would be covered then? And who will even be able to afford it?

What Can You Do?

How well you do on a particular NDT drug depends on how it’s formulated, and the excipients, coatings, and disintegrants it uses. It’s not one-size-fits-all. Some patients do well on Armour, others do best on Nature-Throid, WP Thyroid, or NP Thyroid. Apart from my patient advocacy, I have a vested interest in ensuring that ALL the NDT options remain on the market and affordable, because, in my case, I do best on the WP Thyroid. It has no coatings, and all the excipients are natural, so I have the best absorption and control on the WP. Unfortunately, as of fall 2020, we already have a shortage of some dosages of NP Thyroid, and you currently can’t even get WP Thyroid and Nature-throid!

Patients — including me — are already being forced to take NDT brands that don’t work for them, and pay higher prices for them. And given the situations I’ve been telling you about, it’s likely to get worse into 2021.

We have to speak up NOW, loudly and consistently, to protect our right to take the natural desiccated thyroid drug of our choice — or we risk having only Armour Thyroid as an option, at potentially unaffordable prices.

If you want to protect your right to take the NDT of your choice…

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 william.millar@fda.hhs.gov
• Tamala Bogan, email Tamala.bogan@fda.hhs.gov
• Steven Porter, Jr., email steven.porter@fda.hhs.gov
• Note: Be sure to CC all emails to ORAPHARM2_Responses@fda.hhs.gov
• Call and complain to the FDA main consumer line at 1–888-INFO-FDA (1–888–463–6332)
• Call the FDA Consumer Complaint Division for your region: https://www.fda.gov/safety/report-problem-fda/consumer-complaint-coordinators

2. Report Adverse Effects

If you are forced 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’s Medwatch System for Adverse Effects. You can do this 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. Natural desiccated thyroid drugs have been prescribed safely for a century, and are an effective an affordable treatment option for millions of people with hypothyroidism. Tell the FDA to LEAVE OUR NDT DRUGS ALONE, and DROP THE BIOLOGICS DESIGNATION! You’ll find the FDA on Twitter at https://twitter.com/US_FDA and Facebook at https://www.facebook.com/FDA

4. Stay Informed

Finally, be sure to visit www.naturalthyroidguide.com for news and updates on further action steps you can take. Follow me on Facebook (ThyroidSupport), Twitter (ThyroidMary), and Instagram ThyroidMary. And subscribe to the free Natural Thyroid News email newsletter for the latest updates.