Allergan, Inc. (NYSE:AGN) provided a further update today regarding the investigation into potentially unlicensed and unregulated practices at a facility in Fort Lauderdale, Florida that resulted in the hospitalization of four patients. News reports have surfaced that in a raid of the clinic, Advanced Integrated Medical Center, investigators have found evidence linking the facility to a Tucson, Arizona distributor which has advertised an unlicensed botulinum toxin that has not been approved by the U.S. Food and Drug Administration (FDA) for human use.
"If these reports are accurate, we are appalled and concerned that someone would even consider using an unlicensed and unapproved botulinum toxin on a human being," said Douglas S. Ingram, Allergan's Executive Vice President and General Counsel. "Allergan is aware that a number of unlicensed products have at times been imported into the U.S. and over the last two years we have worked closely with the FDA and local, state and federal law enforcement authorities in numerous investigations regarding the distribution of unlicensed products." Ingram continued, "BOTOX(R) - distributed under the names BOTOX(R) and BOTOX(R) Cosmetic - is the only licensed and FDA-approved botulinum toxin type A product available in the United States. Physicians and patients need to feel confident in the integrity and safety of the products they are administering and receiving."
BOTOX(R) is an important and versatile prescription medicine that has been studied clinically for over 20 years and has been available in the U.S. for 15 years. The safety and efficacy of BOTOX(R) have been established in double-blind, placebo-controlled clinical trials, as well as in open-label studies and extensive clinical practice involving millions of patients worldwide. With more than 1,800 publications on botulinum toxin type A in scientific and medical journals, BOTOX(R) is one of the most widely researched medicines in the world and has been approved for 20 indications in more than 70 countries.
Allergan takes the issue of unlicensed drugs and the potential danger they pose to the public health very seriously. BOTOX(R) is a medical product that is subject to extraordinarily rigorous quality control and quality assurance processes that are overseen by regulatory authorities. The company has in place a number of measures to deter the sale or distribution of unlicensed alternatives to BOTOX(R). For instance, we have employed the latest technology to add an easy-to-identify holographic film to the BOTOX(R) vial which physicians can use to determine receipt of authentic product. The company also has a sophisticated system in place for tracking the shipment of each BOTOX(R) vial sold.
Patients should always verify with their physicians that they are receiving BOTOX(R) and not an unlicensed botulinum toxin. Licensed products available in the U.S. can be verified by checking with the FDA's web site at www.fda.gov. Physicians and consumers with questions may also call 1-800-433-8871 to speak to a company representative if they are unsure a product is the licensed and approved BOTOX(R) product.
Allergan encourages both physicians and consumers to visit its web sites at www.Allergan.com, www.BOTOX.com and www.BOTOXCosmetic.com to learn more about BOTOX(R) and BOTOX(R) Cosmetic. Consumers seeking a qualified injector for cosmetic applications can find a trained physician on www.BOTOXCosmetic.com.
About Allergan, Inc.
Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the eye care, neuromodulator, skin care and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.