Clarity On Cosmetic Injectable Labeling, Use
When it comes to cosmetic injectables, the terms "investigational" and "off-label" are often used interchangeably, often confusing consumers. The Physicians Coalition for Injectable Safety offers consumers these guidelines and definitions:
"A label containing specific consumer safety information is required by the Food and Drug Administration after a drug or medical device has been approved," explained Coalition leader Roger Dailey, MD of Portland, OR. "There are very specific labeling requirements including things such as brand name, drug content, the indications for a drug or device, dosing, adverse reactions, warnings and even data obtained from clinical studies."
A label defines the specific use for which a drug has been approved. "Off-label use refers to the legal practice of prescribing a drug for a purpose other than its stated indication; this is up to your doctors' discretion and is commonly done, however it is illegal for a manufacturer to market, advertise or otherwise promote the off-label use of drugs," said Coalition member Mark A. Codner, MD of Atlanta, GA. "For example, most dermal fillers are specifically approved for use in the nasolabial folds, the creases that run from the outer corner of the nose to the outer corner of the mouth. As a result, other forms of tissue enhancement that are commonly addressed with dermal fillers are considered 'off-label' as these specific treatments were not part of the clinical data submitted for approval," he continued.
"The term investigational means that either a drug or device is being studied in a particular application as part of the process necessary to submit for approval to the U.S. FDA, or that an approved drug or device is being studied for new uses," explained Dr. Dailey. "For example, consider that Botox is approved for many clinical applications and Botox Cosmetic is approved for cosmetic use. However, there is no approval similar or specific to the treatment of headaches with Botox, therefore this is an investigational use -- one that is being studied by physician-investigators."
A complete listing of FDA-approved cosmetic injectables with common off-label uses, and a listing of investigational cosmetic injectables and uses are available in the "Injectables-at-a-Glance" link at InjectableSafety.org. A full glossary of commonly used terms can also be found on the site.
A "Cosmetic Injectable Planner" is also available to download in PDF format, an ideal and easy-to-use set of guidelines for planning a first time or repeat cosmetic injectable treatment. The Coalition offers consumers these very simple questions to ask before considering any cosmetic injectable procedure:
-- Doctor: Is the injectable recommended by a qualified doctor who regularly treats similar conditions, in an appropriately licensed and equipped medical facility? Has the doctor examined the prospective patient before recommending treatment?
-- Brand: Is the injectable recommended approved by the U.S. FDA for cosmetic indications and is it appropriately labeled and packaged to reflect its authenticity and approval?
-- Safety: Is the setting a proper medically-equipped office, with safety and sterilization procedures? Has the physician evaluated conditions, recommended treatment, offered alternatives and clearly defined the potential outcomes including any complications?