Planning for Flu Outbreaks
The FDA issued final recommendations for increasing the supply of safe and effective influenza vaccines for both seasonal and pandemic use. The FDA's goal is to streamline the development and approval of these products, part of its Critical Path Initiative to translate scientific advances into new medical products with shorter approval times. The agency believes that licensing more influenza vaccine manufacturers will improve the capacity to produce more seasonal flu vaccines while strengthening the nation's pandemic flu preparedness, an agency priority.
In March 2006, the FDA issued two draft guidance documents on this topic for public comment--one for seasonal influenza vaccines and another for pandemic influenza vaccines. The guidances, which cover conventional and accelerated licensure pathways, recommend using new technologies such as cell culture and recombinant manufacturing to enhance the development and evaluation of vaccines. The guidances also recommend adding novel adjuvants, substances that improve the immune response from the vaccine.
DEG Detected in Toothpaste from China
Warning consumers to avoid toothpaste made in China, the FDA issued an import alert to prevent toothpaste containing the poisonous chemical diethylene glycol (DEG) from entering the U.S. Toothpaste products containing DEG, used in antifreeze and as a solvent, are typically sold at bargain retail outlets. To be on the safe side, the FDA suggests that consumers throw away toothpaste with labeling that indicates it was made in China.
The FDA does not know of any cases of poisonings from toothpaste containing DEG in the U.S. Nevertheless, the agency is concerned about risks from chronic exposure to DEG, especially in children and individuals with kidney or liver disease. FDA inspectors identified and detained one shipment of toothpaste containing about 3% DEG at a U.S. border. In addition, FDA inspectors found and tested toothpaste products from China at a distribution center and a retail store. The highest DEG level found was between 3% and 4% by weight. The product at the retail store was not labeled as containing DEG but was found to contain the substance.
Action on Unapproved Ingredient Imminent
The FDA announced plans to take action against companies that market unapproved drug products in timed-release dosage form that contain guaifenesin, a common substance in cough and cold medicines that stimulate removal of mucous from the lungs. Approximately 20 companies make timed-release products containing guaifenesin that have not undergone FDA review, and these are considered unapproved drugs by the agency. This action does not affect products containing guaifenesin in immediate-release form, but only the timed-release forms, often described as extended-release, long-acting, or sustained-release.
As of late May, Adams Respiratory Therapeutics was the only company that had obtained FDA approval for timed-release products containing guaifenesin (600 mg and 1,200 mg), sold under the brand names Mucinex and Humibid. These include over-the-counter products containing guaifenesin alone (Mucinex and Humibid) and guaifenesin combined with the decongestant pseudoephedrine (Mucinex-D) and the cough suppressant dextromethorphan (Mucinex-DM).
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