Is the FDA Planning to Get Rid of Desiccated Thyroid Drugs Like Armour & Nature-Throid?
September 2009
I received a call earlier this week from Bruce Scott, the Chief Pharmacist and Senior VP from Medco. He called to attempt to reassure me that Medco was not trying to prevent patients from getting desiccated thyroid when they issued a “Thyroid Products Shortage” alert to physicians, saying that no desiccated thyroid was available (without
first checking on product availability from all manufacturers). That same Medco notice to physicians also included the following statement:
“These medications do not have U.S. Food and Drug
Administration (FDA) approval, and we expect that the FDA will
eventually require these products to be approved and may remove any
remaining unapproved products from the market.”
I took Medco to task online, for speculating about FDA plans regarding desiccated thyroid, when no such actions are public information. At the same time, when I spoke with Bruce Scott, the impression he left with me was that he knew something I didn’t know about the FDAs plans for these medications.
All in all, I was not reassured by this call from Medco. Do I still believe that Medco may have reasons — that do not include helping patients — to have issued their alarmist notice about natural desiccated thyroid, and recommendation that doctors switch their patients to levothyroxine drugs? Yes. Their timeline of notifying doctors before contacting some manufacturers — along with their history of “drug switching” for profit — make it hard to think otherwise.
But could the top pharmacist at one the nations largest pharmacies — which is handling millions of prescriptions per year — know something about what the FDA is planning that we members of the public don’t know? You bet he could.
I did some more digging.
We all know that shortages of natural desiccated thyroid drugs — brand name and generic — have been building since spring of this year.
And the complete nationwide shortages seemed to snowball when the FDA send an enforcement letter to Time-Cap Labs, a drug manufacturer that was making a generic natural desiccated thyroid, and was subcontracting natural desiccated thyroid production for other drug manufacturers. The FDA basically shut down Time-Cap Labs ability to produce any natural desiccated thyroid with the following section of their letter:
In addition to the CGMP violations discussed above, this
inspection also revealed that your firm manufactures and markets
unapproved new drugs in violation of Section 301(d) and 505(a) of the
Act [21 U.S.C. §§ 331(d) and 355(a)]. Based on the information your
firm submitted to FDAs Drug Registration and Listing System and
information collected during the inspection of your facility, your firm
manufactures the following prescription drugs:
- Thyroid 1/2 gr. (32.5 mg) Tablets
- Thyroid l gr. (65 mg) Tablet s
- Thyroid 2 gr. (130 mg) Tablets
- Thyroid 3 gr. (195 mg) Tablets
The above products are drugs within the meaning of Section 201(g) of the Act, [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases.
Further, they are “new drugs” within the meaning of Section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses. Under Sections 301(d) and 505(a) of the Act [21 U.S.C. §§§ 331(a), (d) and 355(a)] a new drug may not be introduced into or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for the drug. Based on our information, you do not have any FDA-approved applications
on file for these drug products.Additionally, the above products are misbranded because, as prescription drugs, adequate directions cannot be written for them so that a layman can use these products safely for their intended uses. Consequently, their labeling fails to bear adequate directions for use as required under Section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] and because they lack required approved applications, they are not
exempt from this requirement under 21 CFR § 201.115. The introduction or delivery for introduction into interstate commerce of these products without approved new drug applications violates Section 301(a) and (d) of the Act [21 U.S.C. §§ 331(a) and (d)].
I know its government gobbledygook legalese, but what the above section says is basically the following:
- According to the FDA, natural desiccated thyroid drugs are not generally recognized as safe and effective
- According to the FDA, natural desiccated thyroid is considered a “new drug”
The bottom line? New drugs must be FDA-approved, and natural desiccated thyroid drugs are not FDA-approved.
Desiccated thyroid drugs were in use in the early 1900s, and already on the market when the government regulatory groups to oversee medications were formed. So they never went through the “new drug application” (NDA) process. The synthetic thyroid drug levothyroxine, however, has gone through the NDA process. Back in 1997, stability and potency problems with levothyroxine drugs like Synthroid caused the FDA to require all levothyroxine drugs, including Synthroid and Levoxyl, to go through the NDA process.
So what does this mean for natural desiccated thyroid? Is the FDA going to shut down production of all natural desiccated thyroid drugs — not just Time-Cap Labs? Will the FDA require natural desiccated thyroid drugs to go through the new drug application process? And if so, will it be sooner or later?
No one knows the answer. But its important to understand that in June 2006, the FDA announced a new initiative to remove all unapproved drugs from the market. You can read the Compliance Guide from the FDA, which outlines how the FDA intends to bring all drugs into the approval process. Note that among those unapproved drugs, the
highest priority — basically, the drugs that will targeted first – will be given to drugs with potential safety concerns, and unapproved drugs that directly compete with an approved drug.
It can be complicated to understand the FDAs position on unapproved drugs, especially when you’re dealing with older drugs, like natural thyroid, that were already on the market and in use long before the FDA itself was created. To understand specifically, read the following 2-page summary article, from the summer 2008 Pharmacy Today
magazine. The article, titled “FDA initiative aims to remove unapproved drugs from market,” explains that all drugs must have FDA approval unless they fall into one of the following categories: “DESI pending, OTC monograph pending, generally recognized as safe and effective (GRASE), or grandfathered.”
Generally recognized as safe and effective (GRASE) means that an old drug doesn’t require FDA approval because its generally recognized to be safe and effective based on published scientific literature.
Grandfathered drugs are drugs that entered the market before formation of the FDA, and their composition and labeling have not changed since 1962. Apparently, since most drugs have undergone some formulation change, the FDA believes that very few drugs that claim to be “grandfathered” actually do have that status.
Thyroid patients and physicians have often assumed that desiccated thyroid is either GRASE or grandfathered. But the April 2009 letter to Time-Cap Labs makes it clear: the FDA does not consider desiccated thyroid to be either GRASE or grandfathered.
And, again, according to the FDAs letter to Time-Cap labs, natural desiccated thyroid is considered a ‘new drug, which means that at some point, the FDA will require natural desiccated thyroid drugs to go through the new drug application process.
Here is a relevant excerpt from the FDAs own discussion of unapproved drugs:
FDA is not required to, and generally does not intend
to, give special notice that a drug product may be subject to
enforcement action, unless FDA determines that notice is necessary or
appropriate to protect the public health.
The FDA says it has the discretion to allow a drug to remain on the market for a “grace period,” especially if removing the product from the market would have an effect on the public health. (This was why, when levothyroxine drugs were forced to go through the new drug application process, they were also allowed to remain on the market.)
In pulling a drug off the market, the FDA, however, considers whether there are “legally marketed products” that can meet the needs of patients taking the drug. And its no secret that the major endocrinology organizations, including the American Association of Clinical Endocrinologists, and the American Thyroid Association, both insist that levothyroxine is the treatment for hypothyroidism, and they specifically do not recommend desiccated thyroid. (Its also no secret that those groups and many of their members are beneficiaries of grants, financial support, and research funding from the makers of levothyroxine drugs. But thats another issue.)
Making the situation even more concerning is the fact that Dr. Sidney Wolfe, editor of the WorstPills.org website, and co-founder – along with Ralph Nader — of Public Citizens Health Research Group, was appointed earlier this year to a four-year term on the FDAs Drug Safety and Risk Management Advisory Committee. The committees role is to counsel the FDA regarding the safety of certain drugs. Wolfe is a major opponent of natural desiccated thyroid, and while remaining woefully uninformed about the drug
— at one point Wolfe even publicly stated that desiccated thyroid on the market today is from bovine (cow) rather than porcine (pig) thyroid — he has campaigned against desiccated thyroid. Now hes in a position to help get it taken off the market.
At this point, patients and physicians can only hope that when the FDA decides to take action against natural thyroid — and I am convinced that this is not a matter of if, but when — we will be able to mobilize to help protect our rights to a medication that has been on the market for more than a century, and is a more effective treatment than levothyroxine for some hypothyroidism patients.
'Is the FDA Planning to Get Rid of Desiccated Thyroid Drugs Like Armour & Nature-Throid?' have 32 comments
July 21, 2017 @ 4:01 pm Patricia
I would like to know when this article was written? I have been having issues with the various NDT since the well reported on issues with changes to Armour Thyroid & have always believed it stemmed from issues with the FDA. This is the 1st article I have found that actually describes the potential issues. I also always thought that there was an issue with forcing reformulation due to the supposed “Pig Flu” epidemic back around 2009. I have been on Armour until 2009 when it stopped working, then switched to ERFA Thyroid which worked very will till 2014 than switched to WP Thyroid which worked OK till this past June 1st & now systems are back.
September 22, 2017 @ 10:41 am Polly I Parker
It is the FDA that stopped the Armour thyroid distribution. It is rediculus because many of us like myself depend on it to keep hypothyroidism under control. I had taken it for close to 55 years and was put on Synthroid which through my thyroid way off. It took six or seven years to get it back in balance. Now I have to order it from Canada until the FDA wakes up and approves it.
December 1, 2017 @ 7:57 am A. Car
Presently I am unable to get my Natures Tyroid filled, how do you order yours from Canada? I have 2 weeks left of my emergency supply and after that I have no idea what to do. I am very nervous to switch to a different medication. Before I started taking this medication I would sleep easily 4 hours a day and sometimes have to sleep in the parking lot in between doing errands because otherwise I would just fall asleep while driving! I cant be without my thyroid medication.
January 3, 2018 @ 11:31 pm Cabro
@A. Car: Try NP Thyroid, by Acella. It is another natural desiccated thyroid formulation (NDT/DTE) with reasonable fillers. I’m in the process of switching over to it from Nature-Throid. My TSH has gone way up this fall on Nature-Throid, even though FT3 and FT4 were unchanged. We were going to have to make a change anyway to try to get TSH back down.
November 10, 2017 @ 2:14 pm Bonnie
Sorry and surprised to hear that WP Thyroid has stopped working well for you, Patricia. It has continued to work well for me, and I’ve taken it for years. However, I can hardly find in pharmacies now. I may have to get my refill made from higher strength tabs that are crushed and put in a capsule (compounded), which is acceptable, though not ideal (I couldn’t chew the capsule up as I do the tablets, for faster absorption.) However, my main concern is that it’s growing harder to get at all, as supplies dwindle due to this FDA insanity. I see that some of the commenters in this thread are getting their NDT meds from Canada. Maybe I will have to do that, too.
February 2, 2018 @ 3:52 pm Dianna
I take WP thyroid and only WP thyroid because for 10 years I was deathly ill from almost all other thyroid medication on the market. With the WP shortage lately I have noticed I’ve been getting ill I am now fighting my pharmacy to make sure they are giving me the real WPS I can take no other replacements . I also contacted RLC labs to see if they’ve change something because I am really very ill now . WP was a lifesaver for me literally. There is something in the colors and binders of all others that make me deathly ill. There are other people many many many who have experienced the same and desperately need this medication and it’s pure form. This is what people do not understand. The lives of many could be lost and many more could be very very severely ill. I am praying please get the word out . Thank you and God bless .
October 7, 2017 @ 11:27 am Terri
I have been sick from all the dissicated medication being reformulated since Armour reformulated in 2009 and have been on Erfa for a year. I just recieved my new medication from Erfa yesterday Oct. 2017 and can tell by taste it is diffrent and it burns my tongue also so it has now been reformulated I’m sure of it and I will be sick once again. I am so sick of the F.D.A. doing this to us why couldn’t they leave our medication alone starting with Armour in 2009.
October 15, 2017 @ 5:48 pm Ann
I think the FDA must not be getting their cut under table on drugs that have been grandfathered in. I too got my Armour from Canada back in 2009 when it couldn’t be found in this country. I’ve been on Natur-Thoid for 2 years because my insurance company would no longer pay for my Armour. It has worked well for me but now I am scrambling to find a supply since Natur-throid, WP Throid and Westhroid are all “back ordered”. Its bs that our FDA can just take medication away from us for no other reason than “they can”. It works for us. WORKS. Like nothing else does. I will go back to buying from Canada FDA! And my doctor fully backs that decision!
October 30, 2017 @ 10:01 am N
Thyroid med from Canada is also unavailable.
October 17, 2017 @ 8:25 am Vicki
FDA approved thyroid medication gave me skin cancer. So FDA stay out of our business. Let those of us who chose to be natural and not chemical in our foods and drugs be natural and not chemical.
Thank you.
Where in Canada can we get Nature Throid?
Thanks
October 24, 2017 @ 7:52 pm Jane
The first post appears to be from 2009 because it talks about being grandfathered in. I spoke with a pharmacist today who said she called Nature Throid today and they said they will not be producing thyroid until late December. Bottom line this is like the great thyroid crash of 2009 no one knows when it will be available but my guess would be a year or close to it, the same as it was in 2009.
As to why the thyroid crash is happening it smells rotten to me, doesn’t make sense for Nature Throid to shut down and upgrade equipment, why wouldn’t they charge more and run the plant 24 hours a day? I don’t think they are telling patients the truth.
February 1, 2018 @ 11:05 pm Christine
I am not happy with this Naturethroid shortage myself. I just was able to find a doc to prescribe it to me a year ago and was doing way better on it than on levothyroxine . Perhaps RCL Labs *had* to do upgrades in order to keep the FDA off their back for a while? I sure hope they can get their stuff straight before too long.
November 3, 2017 @ 1:03 am Tracy Hancock
I have been at Armor and WP Tyroid for 19 years. I can not take synthetic because it causes debilitating migraines. I am to the point for trying to figure out a way to make my own . . . . any experience out there?
November 9, 2017 @ 2:34 pm Courtney
My Nature-Throid RX ran out and the pharmacy had to sub in WP Thyroid, I had a horrible reaction to it, that included hives and an itching tongue. They told me it had to be one of the fillers. Because of the reaction they didn’t want to try a different natural again, so instead the compounding pharmacy was able to make me capsules of just the active natural thyroid. They cost me $30/month out of pocket, but told me they could compound until Nature-throid was available again around December 1st. Well worth it in my opinion. If Nature-Throid has changed it’s formula, I for one will be headed back to the compound pharmacy.
December 1, 2017 @ 8:03 am A. Car
Hi, thank you for sharing your story. I would be willing to pay a compound pharmacy to make my perscription. How do I go about doing that? Do I just take my perscription to them? Thanks for your help.
January 19, 2018 @ 10:17 pm Nina
The only problem with that is they get their ingreidient’s from China and India ALL of them do if they buy their chemicals in bulk!
March 8, 2018 @ 1:25 pm gina
Hi Nina How do you know the ingredients are coming from China and India? IS NDT thyroid powder available from safer sources?
April 2, 2018 @ 9:29 pm Kay
Courtney,
I have been hypo for close to 60 years and on the thyroid rollercoaster most of that time. I managed to have 8 healthy babies, however. But now have been suffering immeasurably w hypo after WP exhausted in my area. My doctor also went to compounding, however, I am still suffering major hypo symptoms. Do you have any idea of the amounts of natural thyroid and what it is called? Also the only filler I can stand is olive oil. I am in Arizona. Would be so very grateful to know what the dosage is of what you have now and by what name. Thanks much.
Kay
November 5, 2018 @ 1:22 pm Judy
Take your TSH to 1.0, even at 2.5 I was terribly moody, overweight and generally gutless.
March 8, 2018 @ 12:58 pm gina
Hi Tracy – I just tried to reply to you and I don’t see it here. I’m with you on making our own NDT and would like to discuss this with you and anyone else like minded in here…
March 8, 2019 @ 1:12 am Danielle
Make your own ndt? I’d be very interested to learn how!
November 7, 2017 @ 11:15 am Carol Brinkley
The FDA routinely approves thousands of un-natural drugs that have copious dangerous life-threatening side effects, to the pleasure and profit of the pharmaceutical industry. The FDA has gifted Monsanto with their approval of Roundup, a known carcinogen as well as toxic pesticides which people ingest with every bite they eat, causing untold sickness and disease. No doubt the FDA imposed desiccated thyroid crisis is being done to benefit the pharmaceutical drug king companies, which in turn benefits the pockets of the FDA officials. It is my understanding that most of the decision making FDA executives come from the very industries that they are supposedly regulating. Conclusion: The FDA is part of the SWAMP!
October 11, 2018 @ 4:29 am Vicki
>yes indeed they are. It I’d all about the corrupt self serving, greedy pharmacy cartels
Time for We the People to seriously Push Back!
November 25, 2017 @ 4:28 pm Vicki
The synthetic versions did not work which is why I’m using Nature Throid. I’m wondering if this can be compounded?
January 19, 2018 @ 10:21 pm Nina
It can but it won’t be naturethroid or wp thyroid as they are a brand. They can compound natural thyroid but they aquire their chemicals from China and India and God knows where else because they all buy in bulk and that is where they come from just as bad a synthetic if you ask me they have been found to contain Lead.
December 19, 2017 @ 1:35 pm Tina purdy
I tried ordering from Canada last year and it was stopped at the border by American border security. Remember when many seniors used to get less expensive drugs from Canada? Congress made sure we no longer have such options.
December 30, 2017 @ 4:39 pm Carey
RE: OPTIONS for Naturethroid and WP Thyroid Shortages:
One of the best web resources I’ve found:
December 30, 2017 @ 4:41 pm Carey
Website was omitted:
January 22, 2019 @ 10:05 pm Jodi
I was also getting from Big Mountain in Canada for another script and checked today and a FDA pop up said dangerous so i pressed CTRl Shift and n and went incognito and accessed site but they are out of the natural drugs.
January 8, 2018 @ 2:19 pm Carol
@Carey would you put that in again? the link seems to have disappeared.
March 10, 2018 @ 10:26 am gina
Carey,
can you private message me the info?
January 9, 2018 @ 12:31 pm June
Last October I was no longer able to get Nature-throid. Was on it for the past 5.5 yrs with great results & no side effects. I am 71. I have been on Levothyroxin for 3.5 mo. Lost half my hair, eyebrows almost gone, nails peeling, skin dry & cracking, runny bowels, acid reflux, hot all the time, face red & flushing, fast pulse up to 110 on this stuff. So the FDA has taken away NT that was helping me. NT has been around many yrs before the synthetic drugs with great results. This is bunk! Dr. Brownstein has several books on this and he also sells a supplement that could help but its $40mo.