There are an estimated 20 million people with some form of thyroid disease, yet the FDA further tightens the screws on natural medicines that could help them. Action Alert!

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.

How can the FDA know how many of a doctor’s patients will actually need such special prescriptions? They can’t, of course. 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—what? Dangerous?

The FDA also lacks legal authority to interfere with the practice of medicine in this way. But a lack of legal authority will not stop this rogue agency. Just to make it even less likely that any such personalized medicine will ever be made, the agency also says that such medicines must also be compounded on an as-needed basis, not on a routine or pre-set schedule.

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.

Is a time-released version 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? The right answer is no, because many hormones should only be administered as creams, but Big Pharma prefers only to offer tablets, so the FDA answer will likely be “Yes, it is a copy,” even though it is not.

Is a more complete or differently weighted version of the hormone a “copy”? Based on past stances of the agency, all of these things are likely to be treated as copies, when once again, they are not.

There are an estimated 20 million people with some form of thyroid disease, and this is widely regarded as an under-diagnosed illness! But don’t think that you’re going to be one of the lucky four allowed to have your prescription filled. Pharmacies may find this so limiting and so risky that they will refuse to fill any such prescriptions.

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. Recall that the FDA is now requiring a note on each prescription detailing how the compounded medicine brings about a specific change in a patient that could not be achieved by the commercially available drug. 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.