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Deal seen for lice shampoo ads - Lindane maker: FDA may OK revamped marketing By Barbara Rose - Tribune reporter - February 1, 2008.
A Morton Grove-based maker of a prescription shampoo to treat head lice s aid Thursday it expects an agreement "in the next few months" with federal officials that will allow the company to resume advertising the drug.
Morton Grove Pharmaceuticals Inc. pulled promotional materials for Lindane Shampoo from Web sites and destroyed copies of a newsletter for school nurses after receiving a warning letter in December from the U.S. Food and Drug Administration saying the materials were misleading.
The shampoo contains lindane, a pesticide that was banned for agricultural use in 2006 but remains an FDA-approved second-line therapy when other remedies fail.
The FDA's letter said Morton Grove's promotional materials downplayed "significant risks" while encouraging wider use with fewer precautions than recommended under labeling. The agency asked for a plan to correct the misleading messages.
"We've committed to the FDA to rectify the communications and work with them in future promotions so we create education and awareness around the appropriate times for the use of Lindane," said Morton Grove's president and chief executive, Kurt Orlofski. "We expect resolution of the entire matter in the next few months."
He said the materials were developed in 2005 and 2006 by previous owners. The specialty pharmaceuticals company, acquired in October by India-based Wockhardt, is the sole U.S. marketer of Lindane Shampoo and Lindane Lotion.
The products, used for more than 50 years, have seen sharp sales declines in recent years because of stricter FDA guidelines for their use. Environmental groups have tried to get lindane off the market.
Head lice affect as many as 12 million people a year, according to FDA estimates.
Medical researchers debate lindane's safety, but the FDA's position is that the benefits outweigh the risks when the shampoo is used according to labeling. Warnings state that seizures and deaths have been reported after repeated or prolonged use, and in rare cases after a single application.
"It's a product we will continue to sell because we feel, as does the FDA, that it meets a very important public health need," Orlofski said.
A measure to ban lindane's use in Illinois passed the state House of Representatives in 2005 but died in the Senate. Bills banning or limiting its use are pending in Michigan, New York and Minnesota, and Morton Grove is lobbying to defeat them. "We feel states do not have a right to ban a product the FDA has determined safe and effective," Orlofski said.
Morton Grove Pharmaceuticals Inc. pulled promotional materials for Lindane Shampoo from Web sites and destroyed copies of a newsletter for school nurses after receiving a warning letter in December from the U.S. Food and Drug Administration saying the materials were misleading.
The shampoo contains lindane, a pesticide that was banned for agricultural use in 2006 but remains an FDA-approved second-line therapy when other remedies fail.
The FDA's letter said Morton Grove's promotional materials downplayed "significant risks" while encouraging wider use with fewer precautions than recommended under labeling. The agency asked for a plan to correct the misleading messages.
"We've committed to the FDA to rectify the communications and work with them in future promotions so we create education and awareness around the appropriate times for the use of Lindane," said Morton Grove's president and chief executive, Kurt Orlofski. "We expect resolution of the entire matter in the next few months."
He said the materials were developed in 2005 and 2006 by previous owners. The specialty pharmaceuticals company, acquired in October by India-based Wockhardt, is the sole U.S. marketer of Lindane Shampoo and Lindane Lotion.
The products, used for more than 50 years, have seen sharp sales declines in recent years because of stricter FDA guidelines for their use. Environmental groups have tried to get lindane off the market.
Head lice affect as many as 12 million people a year, according to FDA estimates.
Medical researchers debate lindane's safety, but the FDA's position is that the benefits outweigh the risks when the shampoo is used according to labeling. Warnings state that seizures and deaths have been reported after repeated or prolonged use, and in rare cases after a single application.
"It's a product we will continue to sell because we feel, as does the FDA, that it meets a very important public health need," Orlofski said.
A measure to ban lindane's use in Illinois passed the state House of Representatives in 2005 but died in the Senate. Bills banning or limiting its use are pending in Michigan, New York and Minnesota, and Morton Grove is lobbying to defeat them. "We feel states do not have a right to ban a product the FDA has determined safe and effective," Orlofski said.
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