Bogus Botox Bust
An entire plastic surgery practice in Albany, N.Y., has pleaded guilty to administering a Botox substitute to some 150 patients. The U.S. Attorney for the Northern District of New York announced the plea, which covered five physicians, the practice administrator, and the supervisory nurse. They admitted that, for most of 2004, they injected patients with botulinum toxin type A [which is now known as onabotulinumtoxinA] that was manufactured by Toxin Research International Inc. of Arizona but labeled as Botox Cosmetic, which is made by Allergan. The Toxin Research product was never approved by the Food and Drug Administration. The physicians and practice employees told patients they were receiving the real Botox and charged them the same price, about $100,000 in total. The practice may have to pay $500,000 in restitution. Each defendant also could face up to a year in prison. Sentencing is scheduled for Dec. 14. The inquiry that led to the guilty pleas was conducted by the FDA's Office of Criminal Investigations.
More Warnings on Injections
The Physicians Coalition for Injectable Safety is warning that mesotherapy and carboxytherapy injections have not been proven safe or effective. The coalition is an alliance of several specialty societies, including a few that have previously warned against the therapies. Practitioners doing mesotherapy and carboxytherapy claim that both procedures can sculpt and contour the body and reduce cellulite. Neither has been approved by the FDA. The Aesthetic Surgery Education and Research Foundation, however, has received the FDA's blessing to conduct a study of mesotherapy. That nonprofit organization is supported by the professional societies and is open to donations from those who want to support research in the field.
Skin Sanitizers Seized
U.S. Marshals have seized skin sanitizers produced by Clarcon Biological Chemistry Laboratory. The seizure had been requested by the FDA, which said that the products were contaminated with bacteria, after Clarcon refused to quickly destroy the various sanitizers and skin protectants that were manufactured at its plant in Roy, Utah. No case of illnesses has been linked to the contamination, the FDA reported. The products, sold under brands such as Dermasentials, Iron Fist, Skin Shield Restaurant, and Skin Shield Industrial, are promoted as antimicrobial agents. More than 800,000 bottles of Clarcon products have been sold since 2007, the FDA said. The agency advised consumers to throw out all Clarcon products in their possession.
Fragrance Ingredient List Coming
The International Fragrance Association announced that it will soon publish on its Web site a list of ingredients used in the fragrance industry. “To support our goal of increased transparency, we have determined that publishing an alphabetized list of fragrance ingredients would be helpful when communicating the industry's extensive safety program,” said IFRA Director General Jean-Pierre Houri. All materials—natural and synthetic—will be listed alphabetically by chemical name and by the Chemical Abstracts Service number. The IFRA is thus joining manufacturers of products for cleaning, air care, automotive care, polishing, and floor maintenance, all of which have agreed to voluntarily disclose ingredients by Jan. 10, 2010.
Biosimilars Market: $45 Million
A research firm pegs the U.S. market for generic versions of biotechnology products, called biosimilars or biogenerics, at $45 million by 2015, if the federal government clears a regulatory path for such products. The major health reform bills now making their way through Congress would do so. Kalorama Information said that biosimilars of human growth hormone, insulin, and some protein and recombinant DNA-based therapies would probably be the first generics available. Early sales aren't likely to be robust, partly because the brand name manufacturers will defend their turf, the Kalorama report predicted. Nevertheless, a few capable generic makers “will hit the ground running in the U.S. once approval [of biosimilars] is granted,” Kalorama's Bruce Carlson said in a statement.
Lilly Payment Data Now Public
Eli Lilly & Co. has made good on its promise to publish how much it pays physicians and other health care professionals in consulting fees, honoraria, and the like. The drugmaker detailed the payments for the first quarter of 2009 at