Have the Amish taken over the FDA?

The Amish must have taken over the FDA. How else could their recent proclamations be explained? This week they sent a letter to Allergan, the makers of the eyelash-growth product Latisse, requiring them to suspend their marketing materials until they could be suitably revised. The concern is that they weren’t emphasizing the potential risks enough. I emphasize “potential” because the primary issue troubling the FDA seemed to be that Allergan was downplaying the possibility of a problem that could occur with a different product containing the same active ingredient, a condition of iris pigment change in a small number of patients. In that case, the product is an eyedrop formulation for glaucoma treatment; in other words, it is placed directly into the eye, unlike Latisse, which is placed onto the skin of the eyelid. So even though there is not a single reported case of Latisse causing iris pigment change, the FDA felt that mentioning the risk as relating only to a “similar” drug was not scary enough. Come to think of it, there are a lot of things that we put on our skin that could cause problems if you get some in your eye. Apparently the FDA just wants women to be plain.

But there’s more to my theory that the FDA is being run by a fundamentalist cult that scorns modern beauty technology. They have also recently updated their requirements for Botox labeling, requiring that practitioners hand patients a “Medication Guide” listing a range of effects than can occur from the toxin spreading beyond the injection site, causing things such as difficulty speaking, trouble breathing, even loss of bladder control. It’s a pretty frightening document until you come to the part about there not being any confirmed cases of any of this happening at the recommended doses. In fact, like Latisse, Botox is an extraordinarily safe and effective product when used properly. It is a bit like having a requirement reminding people every time they start their car that driving 80 miles an hour through a school zone is probably going to cause problems. Or perhaps we should all go back to the horse and buggy. But whether you are following the FDA’s guidance or walking behind a horse, either way you need to watch where you step.