May 13, 2011 – Although there has been the occasional regulatory bump for the makers of prescription skincare products that contain Hydroquinone (HQ) in the United States and Europe for quite some time, the latest announcement from Obagi Medical Products still came as a surprise to many US physicians and patients across the country.
In their Q1 earnings call and related quarterly report released on May 5, 2011, Obagi’s CEO Al Hummel announced that Texas authorities have been going after doctors offices in the state, confiscating Obagi product containing hydroquinone, which presumably would include their Nu-Derm®, Obagi-C® Rx, and ELASTIderm® brands, and citing the doctors for dispensing drugs without a pharmaceutical license.
Mr. Hummel also said that the Texas Attorney General’s office has informed Obagi that selling Hydroquinone through physician and medi-spa offices is against the Texas Food Drug and Cosmetic Act and the Texas Deceptive Trade Practices Act, and at least as far as Texas is concerned, Hydroquinone is an “unapproved Drug”. The company also disclosed that Texas regulatory authorities first contacted them in 2009, and these recent actions appear to be a culmination of their tussle with the agency over the last several months.
Nothing in the Texas actions indicate the regulators have an issue with the safety of hydroquinone administered under a physician’s care. The issue is couched more as an enforcement against the sale of the product outside of a licensed pharmacy. However, these events are a concern for physicians, as they are the target of investigative office “visits”, product confiscations and agency citations – though it is not clear what the nature of those citations are as of yet. Their distress is completely understandable, especially as one looks at the larger trend trend over the last three years that goes beyond state legislative activities:
*August 2006: The FDA issued a new proposed ruling that would ban HQ and any product with “skin bleaching” claims from all cosmetics (currently HQ is allowed in the US at 2% or less concentrations), and require a new drug application process to be completed for all others to show safety and efficacy – they particularly questioned the safety of the product. This ruling would have mirrored similar regulations in Europe where HQ is banned in cosmetics. The FDA has not implemented this proposed ruling, stating that they would sponsor further safety studies before making a final decision.
*August 2009: The FDA issued a warning letter to the CEO of Galderma on improper labeling and promotion of Tri-luma®, an FDA approved product for the treatment of melasma which combines 4% HQ with retinoids and a topical steroid. In part, the warning letter states that, “This unapproved [product material] includes several false and misleading claims about the product, including claims that suggest unapproved new uses and overstate the effectiveness of Tri-Luma, and it omits risk information and minimizes the risks of using Tri-Luma.”
In other words, Tri-luma is approved as an effective treatment for Melasma over few weeks or months under a physician’s care, but over time it has been treated too much like an ongoing daily skin-care regimen by patients who are looking for long-term solutions to their hyperpigmentation. In fact, the FDA was very clear in their letter, stating that Tri-luma “is NOT [approved] for the maintenance treatment of melasma”, noting that it should be for short-term use, and patients need to be more informed about safety concerns and the potential for long-term damage to the skin if used for extended periods of time.
*August 2010: Doctors were largely surprised to wake up one day and find that Galderma, issued a manufacturer’s recall of all Tri-luma product in the US and certain other countries. The reason given on totalrecallinfo.com was that it was due to a “manufacturer notice of sub-standard ingredient”. While this is an unusual occurrence for this type of topical prescription, it is not unheard of and so many physicians expected it to be a temporary disruption; however, in the 8 months since, the makers have not resumed production and sale in the United States, and they have made no statement of when or if they ever will.
*October 2010: The Journal “Dermatologic Clinics“ released a new report entitled “Widespread Use of Toxic Skin Lightening Compounds: Medical and Psychosocial Aspects“. The report was authored by four prominent US physicians and cited a variety of evidences associating the use of HQ with many types of skin disorders, including a permanent darkening of the skin, known as ochronosis. The report dispelled the notion that these risks were found only with high HQ concentrations over 4%, citing cases related to concentrations as low as 3.5%. The report also noted that “contact dermatitis”, generally a temporary though undesirable side effect, occurs in about 70% of the patients who use HQ.
*April 2011: According to court documents, a lawsuit was filed in the Superior Court of the State of California, in San Francisco county by a woman who is suing Rodan and Fields, LLC., the company founded by dermatologists of the same name who garnered great success with the Proactiv® line for acne. They also happen to be makers of a 2% hydroquinone product under the Rodan & Fields “Reverse” brand. According to the claim, this woman has developed irreversible skin discoloration and permanent disfigurement to the skin on her face, alleging that it comes from the use of Dr. Fields and Dr. Rodan’s HQ product.
The suit also notes that she was never properly informed of the risks associated with Hydroquinone, or that there are other safer alternatives commercially available, but that the defendant “knew or should have known” about these risks in supplying the product. This is a very new case, and so the merits and outcome are not known. It may be the first case of its kind in the United States, citing documented safety concerns with HQ as part of a foundation for claims related to using HQ products. The question is whether this is a foreshadowing of things to come.
This brings us back to today and the events taking place in Texas. Obagi noted that Texas accounts for nearly 9% of their total company revenues. As a result, the company has reserved just under $2 million in order to cover product returns from their physician customers. They will continue to look for ways to change the minds of the Texas authorities and, in the meantime they say they will offer non-HQ alternatives.
Obagi selling non-HQ alternatives is very much in line with the times. The Obagi brand became the largest physician dispensed brand by selling HQ products. Now they appear to be joining doctors and patients across the country in looking for a better alternative for addressing skin hyperpigmentation.
Fortunately for patients, there are excellent new treatments and products that help address hyperpigmentation in skin. One such example is the SilkPeel® Dermalinfusion™, a device that combines microdermabrasion with the delivery of a skin brightening peptide manufactured under the “Lumixyl®” brand. Physicians around the country have been using this process very successfully.
“Until now we really haven’t had anything that works so effectively on hyperpigmentation and discolored skin.” Said Dr. Ashish Bhatia in speaking of the Lumixyl SilkPeel procedure and a Lumixyl topical system used by the patient at home.
Lumixyl, discovered by Stanford Researchers and Dermatologists and made by Westlake Village, CA based Envy Medical, Inc., is one of the few non-toxic, topical products that is approved as a cosmetic for ongoing use, giving it a huge advantage, as patients become more aware of the constraints in using HQ products on a temporary basis. The Lumixyl Topical Brightening System, just introduced in 2010 and already available in over 25 countries, appears to be hitting the market at just the right time.
For media inquiries, contact Melissa Kelz, Principal, Melissa Kelz PR at email@example.com (312) 543-8300.
Related Post: Why Was Tri-Luma Recalled?