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Dr. Lupo explains the importance of FDA approved products
Physicians in their best judgment and based on their training and experience, decide if it can be used for another indication such as lipstick lines the doctor can use it and it is called off the label of the FDA.
The FDA governs, controls and restricts drugs and drug companies, devices, and device companies. But it does not have any control over what is known as the practice of medicine.
As a physician, if what you are using is legal in the United States, you are not illegally importing something. For example, if you take Botox and you use it in areas such as the down returning mouth that is an appropriate use of it as a physician.
It is just that it is not FDA approved, so the company can't advertise it or promote it for that use if they did that would be illegal. This is where the artistry and the experience of a physician become very important - this is where the innovation comes from.
When Botox was originally used in one area doctors tried it in other areas and reported back to the company that it worked in other areas too. When this happens, the company will do their due diligence to get it FDA approved so that they can advertise saying that It also works for crow's feet and forehead lines as well.
It is very expensive for a drug company to get FDA approval. The regulatory hurdles that they had to jump and then they require to hire physicians to do the formal clinical trial.
This becomes a very expensive proposition. They need to make sure that it is cost-effective to use their funds for research and that they will get a good return on investment of the money that they put in for that research to get the FDA approval. So that when they do advertise it, there is a market for it, and patients will seek it out.
Our mission at the Lupo Center is to provide patients with innovative, effective and ethical care to make each person look and feel their personal best. To fulfill our goal, we provide state-of-the-art medical, surgical and cosmetic treatments to all patients.
Board certified dermatologist and clinical professor of dermatology Mary P. Lupo, MD has been a leader in the field of non-surgical rejuvenation since 1983. She travels internationally to teach her innovative techniques, and her reputation brings in patients from around the country. She started the first formal residency training program for injectables and peels in 1983 at Tulane Medical School and served as past president of Women’s Dermatologic Society, adjunct professor of dermatology at Tulane and a founder of Cosmetic Boot Camp. Dr. Lupo holds membership in many prestigious dermatology associations, participates in clinical trials for approval of new drugs and devices and acts as an advisor for numerous aesthetic-minded companies.