Will the FDA Take Action Against Lumigan Copycats?

Yesterday I wrote about how plodding and costly the FDA drug and medical device approval process is. However it sometimes protects consumers in ways that become abundantly clear after the fact – after people have been injured, maimed, or worse – using products which do not have the FDA stamp of approval.

Even with all the FDA does to assure that only safe and efficacious medical products are available in the U.S., there are ways for companies to circumvent the process. One completely legal way is for cosmetic companies to include “drugs” in their products but make no medical claims.

In my review of Peter Thomas Roth’s Lashes to Die For, I explained that the formula uses an analog of an ingredient (Bimatoprost) in Allergan’s patented glaucoma drug, Lumigan. Bimatoproat has the marvelous side effect of producing luxurious long lush lashes.

Can something that accomplishes such a feat not be considered a drug? The cosmetic companies which use Bimatoprost or their own analog of it, scrupulously avoid making medical claims for their eyelash enhancement products.

Allergan has filed suit against several cosmetic companies for using its patented creation. The suit is expected to come to trial in November 2009. In the meantime, Allergan developed Latisse, a drug specifically for the treatment of hypotrichosis (alopecia) around the eyes. For the time being, you can buy similar products, like Peter Thomas Roth's Lashes to Die For less expensively and without prescription.

This is such a complex issue that I don’t want to take sides. What is a drug? How can the drug companies recoup their gazillion dollar R&D efforts and the cost of obtaining FDA approval if cosmetic companies can create knockoff ingredients? What should consumers be allowed to purchase OTC?

As for me, I suspect that cosmeceutical eyelash enhancements products may not be available OTC for much longer. I am stocking up.

Tags: eyelash enhancement products, FDA approval process, ingredients which grow eyelashes, Allergan patented bimatoprost, bimatoprost analogs, grow lush lashes, Peter Thomas Roth Lashes to Die For availability, Allergan bimatoprost lawsuit