A very overreactive rumor is being started as I type this about the FDA and Armour, and I think this whole topic needs to be leveled out. The rumor is as follows:

1) The FDA has stopped manufacture of all grandfathered drugs like Armour.
2) Armour will no longer be available at your local pharmacy

i.e. it’s being banned, discontinued, taken off the market, gotten rid off…you name it.

Now first let me clarify that all are totally and completely false. Forest Labs is still making Armour, and you can also find Armour at your local pharmacy, even if certain strengths are easier found than others.

Here is what is going on: In the January-February issue of the 2007 (i.e. a YEAR AGO) FDA Consumer Magazine, an article came out by Michelle Meadows titled The FDA Takes Action Against Unapproved Drugs. But this is NOT new news. This is based on the June 2006 release guidance by the FDA, called Marketed Unapproved Drugs—Compliance Policy Guide. What the FDA is doing is working to get unapproved drugs meet their approval guidelines.

What is an unapproved drug? For one, they are those drugs which were around before the FDA (Federal Drug Administration) came into existence in 1938, and these drugs were ‘grandfathered’ in with the subsequent FDA-approved drugs thereafter. (Armour is an example. Synthroid was too until it did what it took to be approved in 2002) Other examples, as explained in the January/February 2007 article, are when only one company may have approval to market a drug, but other companies are illegally marketing their versions of the drug without having gone through the FDA’s approval process. Another scenario is that a combination of ingredients is approved by the FDA, but a company is marketing a single ingredient without approval.

The article also clearly states: Before pursuing regulatory action against unapproved drugs, the FDA plans to consider the effects on the public health, including whether the product is medically necessary. The agency recognizes that some unapproved therapies offer benefits. An example is Phenobarbital, a drug used to control seizures. In some cases, FDA action requiring drug approvals will be gradual to avoid shortages of medically necessary products. In other words, whenever the day may come that Forest Labs is asked that Armour meet the regulations of the FDA, the process will be gradual and Forest will be given a fair deadline to do what it takes.

Kathy, a pharmacist with Forest Labs, reminds us that Armour has never been asked to go through that process (or they may not be admitting it yet so they can go through it in peace.). And if the day comes, they will do what it takes. Armour is a safe and life-giving product. And you bet your booties that even if it looked threatened some day, there would be a huge uprising from patients to stop it. But that’s not going to happen, just as it was for Synthroid where Abbott labs did what it took to be approved, and succeeded.

So, take heart: everything is fine. Armour is still being made. Your pharmacies still have it, even when some strengths are easier to come by than others. And I’ll keep you informed. And remember: I’ve always told you to stock up on your desiccated thyroid products anyway.

p.s. The root of the rumor comes from a recent recall by Forest Labs concerning its 3, 4 and 5 grain tablets, which had a 6-month potency problem, and a misunderstanding about it’s implications by individuals. Those tablets are currently scheduled to be out again by the end of January.

http://www.fda.gov/fdac/features/2007/107_drug.html
http://www.fda.gov/cder/guidance/6911fnl.pdf

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This entry was posted on Friday, January 11th, 2008 at 10:38 am and is filed under Armour. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.