Now that the Unapproved Drug Initiative Is Back on the Horizon, FDA Makes Noise About Unapproved Prescription Thyroid Drugs

In a recent Consumer Update published on its website, the FDA provides a very brief history of the origin of thyroid treatments, noting that the first versions of thyroid replacement products were made from the glands of pigs or cows.  The discussion moves on to describe the new generation (well, not too new) of synthetic versions of medications that treat thyroid disease, noting that many people still use the older, unapproved versions.

It is noted that the FDA is trying to get firms to submit NDA applications for approval of these older, unapproved products, and it extolls the virtues of applying the approval process to these older, unapproved desiccated thyroid versions.

The Agency notes that the unapproved products do not have demonstrated safety and efficacy because there can be significant batch-to-batch variability, leading to either too much or not enough of the thyroid extract, both of which can make patients sick.  The manufacturing process is complex for the desiccated thyroid products and can lead to quality issues that can impact dosing.

The FDA recommends that patients taking these older products speak to their doctors about which drug is right for them, noting that today’s synthetic versions have much better controls, and, since very minor differences in dose levels are required (at the microgram level), newer products are likely a wise choice for those having trouble controlling themselves on the older, unapproved desiccated products. The FDA recommends that patients speak to their healthcare provider to discuss making any drug changes.

Reading between the lines of the Consumer Update (here) leads me to believe that the Agency might be getting ready to dust off the unapproved prescription drug policy to rectify any potential problems if someone gains approval of a desiccated thyroid NDA.  As we know, much of the stink about the unapproved drug initiative has focused on cost.  The good thing here is, even if an NDA gains approval for the older version of a desiccated thyroid product and the application holder raises prices significantly as other unapproved versions are forced off the market, the synthetic version offers an inexpensive alternative to the natural version.  Hence, no cost concerns!  Now, that is something to think about!  Aren’t you “gland” I brought that to your attention???