Protect Access to Thyroid Treatments!

The Food and Drug Administration’s most recent guidance on customized natural medicine once again threatens to limit patient access to important thyroid medications. The guidance document deals with natural medicines that are “essentially copies of commercially available drugs.” This refers to a medicine made by a pharmacist or doctor that has the same active ingredient, dosage, and route of administration as a pharmaceutical drug currently on the market.

The guidance strictly limits the quantity of these kinds of medicines that can be prescribed. The FDA is essentially saying that copies or near-copies of commercially available drugs cannot be compounded unless a doctor writes a specific prescription noting how a specific change will benefit a particular patient—and the FDA notes that this exception should rarely be used.

How rarely? The FDA says that it does not intend to take action against a doctor or pharmacist if they fill four or fewer prescriptions of the medicine in one month. Will the agency take action when the number is five? Given this wording, it is likely.

These crazy rules could cause real harm to thyroid patients, among many others. If the FDA determines that compounded thyroid hormones are essentially copies of commercially available products like Cytomel or Synthroid, doctors will only be able to write four or fewer prescriptions each month.

Write to the agency and urge them to maintain access to these medicines!

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Maintain access to thyroid medicine

Dear [Decision Maker],

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I was troubled when I heard that the FDA's new guidance on essential copies of commercially available drugs.

The FDA says that it does not intend to take action against a doctor or pharmacist if they fill four or fewer prescriptions of the medicine in one month. How can the FDA know how many of a doctor's patients will actually need such special prescriptions? They can't. By allowing four prescriptions per month, they are acknowledging that some people need such medicines--while offering no logical or medical explanation for declaring, essentially, that four prescriptions per month is perfectly all right, but five is unacceptable.

I'm concerned that this guidance could cause real harm to thyroid patients, among many others. If the FDA determines that compounded thyroid hormones are essentially copies of commercially available products like Cytomel or Synthroid, doctors will only be able to write four or fewer prescriptions each month.

Is a time-released version of thyroid medicine a "copy"? Time-released thyroid is generally compounded today. Will that no longer be possible? Is a topical cream version a "copy" of a tablet? Is a more complete or differently weighted version of the hormone a "copy"? Patients rely on these medicines, and I'm concerned that the wording of this guidance threatens their access to them.

Other types of patients are also at risk. Patients that need to reduce the load of chemicals introduced into their body because of a genetically impaired detoxification system, a hyperactive immune system, or because of a disease like late-stage Lyme or multiple chemical sensitivity are typically prescribed custom medicines that limit their exposure to chemicals and dyes. The problem is it can be extremely difficult to determine the exact chemical that a patient reacts negatively to, which is why these patients are given medicines free of most additives. By the letter of this guidance, these patients are also likely to lose access to their medicines.

I urge you to amend this guidance to maintain consumer access to these medicines. Four prescriptions per month is an arbitrary number that could cause real damage to patient health.

Sincerely,
[Your Name]
[Your Address]
[City, State ZIP]