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Surgery and Cosmetics

James M. Spencer, MD, MS

Off-Label Cosmetic Use and the FDA

James M. Spencer, MD, MS

Tuesday, May 01, 2007

In the United States, the Food and Drug Administration (FDA) exists to protect and assure the public that medications are safe and effective. The process of bringing a new drug to market is an arduous one, beginning with detailed animal data on toxicology, pharmacology, pharmacokinetics, and interactions with other drugs. This is followed by extensive human testing culminating in phase III clinical trials. The new drug must be both safe and effective, in which benefits clearly outweigh risk. Modifications of an existing drug require a new drug application to the FDA in which the entire process is repeated. It is estimated that drug development takes 7 to 9 years from the time the drug is first synthesized until it can be sold to the public, at an average total cost that may exceed $800,000,000.1

The FDA has recently received some bad publicity from a few isolated cases, most notably the recent controversy with the drug Vioxx (rofecoxib). The accusation has been casually made that the FDA is "too close" to the pharmaceutical industry, but the time, trouble, and expense of getting a new drug past the FDA suggests just the opposite: The FDA is truly a difficult barrier to bringing a new drug to market.

One can imagine that avoiding the FDA new drug process would be in a manufacturer's interest. Dermatologists may be interested to know some manufacturers of the new fillers and topical preparations they give to their patients did just that: They did not seek approval as new drugs, but rather as medical devices.

Medical devices are machines, instruments, or implants intended for the diagnosis, prevention, or treatment of disease, such as a laser or a pacemaker. For many years, regulation of medical devices was minimal under the Food Drug and Cosmetic Act of 1938. This law was intended mostly to limit economic fraud, not to judge medical safety or efficacy. Problems with the Dalkon Shield intrauterine contraception device led to the Medical Device Amendments of 1976, which established guidelines and regulation of medical devices under the FDA.

New medical devices can be brought to market as a PMA (pre-market approval), which is much like a new drug application, or as a 510(k) submission, which is a device whose safety and effectiveness is said to be the same as an already approved "substantially equivalent" device. Both are less arduous than the application for a new drug, and the 510(k) process is particularly less difficult and expensive. Most new lasers or intense pulsed light (IPL) devices are brought to market as 510(k) applications. In most 510(k) applications, no clinical data is submitted at all for approval.2 New devices that are a variation of an already approved device simply need to show equivalence. A small number of patients, often less than 10, need to be treated in order to get FDA approval.

While dermatologists are used to thinking of lasers and IPLs as devices, it may come as some surprise that recently introduced creams for indications such as atopic dermatitis or wound healing are classified as medical devices, not drugs. Examples of these new devices are the creams MimyX and Biafin, respectively. Similarly, injectable fillers are not considered drugs, but rather are medical devices and thus approval is a much easier path.

Further minimizing the FDA process is off-label cosmetic use. This refers to a drug or device receiving approval for one specific medical use, when cosmetic use is clearly the intended one. It is perfectly legal for doctors to use a medication or device for an "off-label" indication. This means that if a product is FDA-approved for one specific use, doctors are free to use it for other purposes. On the other hand, the manufacturer is barred from promoting off-label use in any way.

However, this is a bit of gray zone as manufacturers have sponsored cosmetic surgeons to give lecturers and demonstrations of off-label cosmetic use of their filler. Although physicians' formal presentations are regulated, their responses to questions are not, and at that point, they are free to advocate off-label use. Thus, the FDA does not regulate physicians or the practice of medicine except when physicians represent manufacturers. When serving as an agent of the company they are subject to the same rules concerning off-label promotion.

One example is injectable polylactic acid. This device was FDA approved on a compassionate basis to treat HIV lipoatrophy. Once approval was obtained, the manufacturer quickly sponsored cosmetic surgeons to give lectures and demonstrations of the cosmetic use of this preparation, a much larger indication. Doctors were free to use this off-label; although, it is not clear that all liability insurance carriers will insure off-label use.

The important point here is for dermatologists to understand the complexities of the regulatory process, and that not everything that sounds like a drug actually went through the FDA drug approval process.

References

  1. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003 Mar;22(2):151-85.
  2. Newburger A. Cosmetic medical devices and their FDA regulation. Arch Dermatol. 2006 Feb;142(2):225-8.
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