Is FDA investigating Physicians using Illegal Botox?

By Dr. Stephen Cosentino

PRESIDENT OF EMPIRE MEDICAL TRAINING

Is the FDA investigating Medical Spas and Physician offices for using Illegal Botox ?

Ever wonder why other aesthetic practices offer Botox© procedures for as little as $8.00 - $10.00 per unit?  Have you ever received e-mails from internet pharmacies offering 100 unit vials of Botox© for hundreds less than the pricing from Allergan?  Well, odds are the products they are promoting is not Botox© Cosmetic as labeled and packaged for the United States as a prescription item.  Though the practice by unethical pharmacies and unsuspecting physicians is now the forefront of a new nationwide investigation by the FDA to crack down on the illegal distribution and uses of imported Botox© not marked or labeled to be used in America. The practice by physicians of using Botox© not marked for distribution or use in the United States has become rampant in recent years as there was little regulatory control to discourage its use.  Many physicians considered a gray area since they purchased and received the prescription drug within the United States and many websites exploited this point to persuade doctors that it was OK to purchase and use the drug.  However, the FDA has now definitely defined this issue by stating that if the product does not contain the Rx label, labeled for use in the United States, labeled as Botox© Cosmetic, and has the “N” code next to the bar code then it is not approved for use in the United States.

Though it sounds unfair that Allegan and Botox© are able to charge hundreds of dollars more in this country than in others it is because it is a prescription drug (Schedule 2) and is regulated.  By cracking down on its illegal purchasing by physicians in the United States, the FDA has balanced the playing field for all physicians which are a good thing for physicians though maybe not the consumer.  Now all physicians will be paying the same for Botox© which will make it equal to all physicians to sell these procedures at a fair price. Empire Medical Training has always condoned the safe practice of purchasing Botox© from Allergan or through approved distribution (i.e. McKesson) due to the many benefits in buying from the Allergan directly such as:

• Access to the Physician Network of Allergan
• Access to HA Dermal Fillers (i.e. Juvederm Ultra© & Juvederm Ultra Plus©)
• Access to collagen products; Cosmoderm© and Cosmoplast©
• Access to Latisse© and cosmeceutical line; MD Forte©
• Enrollment in Allergan Rewards rebate program
• Marketing support (referral program, brochures, promotions, training materials, etc.)

As part of our Complete Botox Training you will receive the proper information as to where to purchase the product as well as pricing and packaging information to be able to incorporate these procedures seamlessly within your practice.  In addition, Empire Medical Training offers specific marketing strategies and options for your continued success blending medicine and aesthetics as part of your physician practice.  So next time someone offers pricing to good to be true – they are probably right in that it is too good to be true – be safe!