Is the FDA Planning to Get Rid of Desiccated Thyroid Drugs Like Armour & Nature-Throid?

By Mary Shomon, About.com Guide August 19, 2009

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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 FDA's 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 nation's 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 FDA's 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 it's 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 it's 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 FDA's 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 it's 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 FDA's 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 FDA's 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 it's 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. (It's 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 that's 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 Citizen's Health Research Group, was appointed earlier this year to a four-year term on the FDA's Drug Safety and Risk Management Advisory Committee. The committee's 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 he's 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.

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