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There are two types of approval processes for medical products. Oneis the drug approval process and the other is the device approvalprocess.
Q What is the difference between a drug and a device?
A There are two types of approval processes for medical products. One is the drug approval process and the other is the device approval process.
This is an important understanding because many devices are now being advertised to the dermatologist as "approved devices." Just because a device is approved, does not mean that it works. A device manufacturer can submit data on only 10 to 12 subjects and receive clearance. This is not the case for a drug manufacturer who must submit data on thousands of patients to receive clearance.
Q Why are so many new devices entering the acne treatment market?
A Indeed, many new acne devices are entering the medical market.
Probably the most widely marketed acne device produces low-level heat, which is applied topically to inflammatory acne papules and pustules. It is theorized that the external heat decreases the colonization of p. acnes thereby improving acne. This is the same theory behind acne devices that administer blue light, which also decrease p. acnes colonization.
Approval of these devices means that they are considered safe, but, as mentioned previously, there is no promise of efficacy.
I believe that many acne devices are entering the market in the United States following a trend already well established in Japan. Japanese spas are finding financial success in selling equipment for a variety of conditions, including hair removal, hair growth, cellulite reduction, breast enlargement, wrinkle improvement, acne treatment, etc., in the $500 to $1,500 range per device.
The profit margin for both the manufacturer and the salesperson is high for most of these devices. The average mark-up is 500 percent on such sales, which is much higher than for facial creams. Thus, device sales are a lucrative market in a world where technology is supreme. I predict that dermatologists will be visited by an increasing number of company representatives hoping to entice the physician into becoming a retailer for his/her products.
Q Can a cream be a device?
A Yes, believe it or not, a cream can be a device, but a device cannot be a drug.
The first cream device was approved in 2005, successfully blurring the distinction between dermatology drugs and dermatology devices. The topical cream was approved as a device based on the fact that it increased the water content of the skin as demonstrated by noninvasive techniques, such as transepidermal water loss. The increase in stratum corneum water content was felt to be a physical change induced by the cream, thus it received device approval.
Basically, the cream contained a powerful humectant that attracted water functioning in much the same way as many over-the-counter moisturizers.
Q Could most moisturizers then be considered medical devices?
A Absolutely, if they chose to submit an application for device approval.
This then begs the question as to why a basic moisturizer formulation would even be submitted as a device. The answer is that now the manufacturer of the cream device can state that their product is approved, but not as a drug, only as a device. This approval makes the cream a prescription product, but no standard for efficacy must be demonstrated. Thus, we now have an approved device cream for which a prescription must be written.
Zoe Diana Draelos, M.D., is a clinical associate professor of dermatology, Wake Forest University School of Medicine, Winston-Salem, N.C., and primary investigator, Dermatology Consulting Services, High Point, N.C.Questions may be submitted via e-mail to firstname.lastname@example.org