Obama administration may mean tougher FDA recalls
September 7, 8:42 AM
Little Rock Healthy Living Examiner
Suzanne Leavitt
President Barack Obama (AP Photo/Charles Dharapak)Time will only tell if this speculation proves true, but it appears to be the case with reference to the recent actions of the FDA against the popular homeopathic cold remedy Zicam Nasal Gel and Zicam Nasal Swabs. These products have been manufactured by Matrix Initiatives since 1999.
Throughout the Bush Administration, the FDA received 130 reports from users of Zicam and doctors who treated Zicam users for a condition called anosmia, whereby the patient will lose their sense of smell. This can have serious and dangerous life threatening consequences, since the person will be unable to detect gas leaks or smoke from a fire. Quality of life issues also surround the condition, since the patient is unable to detect certain flavors without their sense of smell. Zicam contains zinc and is toxic and destructive to nasal receptors.
The medical society has known this fact since the 1930’s when clinical trials for a intranasal treatment containing zinc was conducted for a polio preventative. Lawsuits began to be filed by Zicam users and in 2006, $12 million was spent by Matrix Initiatives to settle some of these lawsuits, still without any strong enforcement action taken by the FDA. Even though the reports were coming in to the FDA concerning the damage caused by Zicam, no recalls were being requested by them. But with this recent aggressive action taken by the FDA, it appears to indicate that the Obama administration might be somewhat tougher on drug companies than their predecessors.
Present FDA officials remarked that the incidences associated with Zicam struck them as a fairly large problem and issued a consumer alert even when Matrix refused to recall the product. Matrix maintains that their product is safe and plans to request a meeting with the FDA to discuss the product’s safety data. The company agreed to suspend shipments of Zicam and offer refunds, but still refuses to order a recall. The FDA issued a warning June 16th for consumers to stop using Zicam Nasal Gel and Zicam Nasal Swabs. The Obama Administration’s FDA has also worked to push bills through Congress to give them the power to order product recalls, something they presently do not have.
In the past, the FDA has accomplished this task by requesting manufacturers to cooperate with them by issuing recalls voluntarily. However, as can be seen with this Zicam dispute over safety, this can sometimes create delays in consumer protection. Matrix received over 800 reports of anosmia in connection with the use of Zicam, but they did not turn over those reports to the FDA. Since the product is labeled as a homeopathic product, Matrix was not required to seek the FDA’s approval before putting it on the market. The FDA did not issue any warnings with regard to Zicam’s tablets or lozenges, strictly the intranasal gel or swabs which account for 40% of the company’s $101 million in sales last year. Since that initial settlement, hundreds of more lawsuits have been filed. |
