Sunscreen Label Delay Decried
Lawmakers are urging the Food and Drug Administration to release comprehensive sunscreen labeling that has been in the works for several years. Sen. Christopher Dodd (D-Conn.) and Sen. Jack Reed (D-R.I.) introduced a bill to require the FDA to issue final sunscreen rules by February 2009. The Sunscreen Labeling Protection Act of 2008 (S. 3425) is not the senators' first foray into the labeling controversy, as they have called for sunscreen rules since early 2006. "The FDA's current standards for sunscreen testing and labeling leave Americans with a false sense of security about whether their sunscreen protects them from harmful UVA rays," Sen. Dodd said in a statement. The senator said the legislation is supported by the American Cancer Society, the Melanoma Research Foundation, Citizens for Sun Protection, the Environmental Working Group, and sunscreen manufacturers Banana Boat and Hawaiian Tropic. Connecticut Attorney General Richard Blumenthal joined the senators, sending a letter to FDA Commissioner Andrew von Eschenbach calling for an immediate implementation of the rules proposed by the agency in August 2007. Mr. Blumenthal had petitioned the FDA to propose and implement sunscreen standards in May 2007.
FDA Seizes Hydroquinone
The FDA seized $24 million worth of unapproved drugs, including several hydroquinone cream products, from a St. Louis manufacturer. The agency took the action after an inspection of several plants owned by KV Pharmaceutical Co. The FDA determined that KV was not complying with a May 2007 notice requiring companies to stop manufacturing timed-release products containing guaifenesin and to stop shipping those products by November 2007. That notice was part of a larger effort by the FDA to begin removing unapproved drug products from the market. The FDA inspection found that KV was also manufacturing many other unapproved products, including hydroquinone 4% cream and hydroquinone 4% cream with sunscreen. KV issued a statement saying that the guaifenesin products had been manufactured by a company it acquired and that it was set to dispose of them. The company also said in a statement that it "will continue its cooperation with the FDA in bringing this matter to final resolution."
Survey: Only 15% Get Skin Exams
In a national survey, only 15% of American workers reported ever having a head-to-toe skin exam. Only 8% of those who had seen a physician in the past year reported having had such an exam, according to a study published in the July issue of the Journal of the American Academy of Dermatology. Researchers from the University of Miami and the University of North Carolina, Chapel Hill, analyzed data from the 2000 and 2005 National Health Interview Survey, an annual, in-person survey conducted by the National Center for Health Statistics. Based on their analysis, they estimated that 106 million workers have never been fully examined by a dermatologist or any other physician. Farm workers and blue-collar workers had the lowest screening rates. In 2005, only 2% of farm workers and 5% of blue-collar workers reported a skin exam in the previous 12 months, compared with 10% of white-collar workers. Blue-collar workers also had the lowest lifetime screening rates, ranging from 3% to 9%, compared with 11%32% for white-collar professions. "The rate of reporting skin cancer screening was lowest for high-risk occupations most likely to experience increased sun exposures," wrote the authors. The research was supported in part by the National Institute of Occupational Safety and Health.
Stiefel Completes Acquisition
Stiefel Laboratories has completed its purchase of Barrier Therapeutics, a Princeton, N.J.-based company that has three topical products on the market, Xolegel, Vusion, and Solage. "Barrier's innovative products and pipeline are a very valuable addition to Stiefel," company CEO Charles W. Stiefel said in a statement. With the purchase of Barrier, Stiefel adds a development portfolio that includes products for onychomycosis, psoriasis, acne, skin allergies, and acute fungal infections. The family-owned Stiefel claims to be the world's largest dermatologic specialty pharmaceutical company. It does not publicly report sales or earnings.
Feds Scrutinize Generic Maker
India's Ranbaxy Inc., one of the top 10 generic drug makers in the world, is being investigated by various arms of the federal government for allegedly introducing "adulterated or misbranded products" into the U.S. market. The company's auditor, Parexel Consulting, is also under scrutiny. According to a subpoena for documents filed in the U.S. District Court for the District of Maryland by the Department of Justice and the U.S. Attorney's Office in Maryland, Ranbaxy submitted false information to the FDA on sterility and bioequivalence, covered up good manufacturing practice violations, and defrauded Medicare. Reps. John Dingell (D-Mich.) and Bart Stupak (D-Mich.) said that they will formally investigate the Ranbaxy situation. "If these allegations are true, Ranbaxy has imperiled the safety of Americans in a manner similar to the generic drug scandal we uncovered 20 years ago," said Rep. Dingell. "I would like to know whether FDA officials knew about these allegations and what, if any, action was taken."