The company said in its letter that it was initially delighted that the FDA agreed to review its decision to issue a "consumer warning" in mid-July, demanding that the company's nasal sprays be pulled from store shelves. (Matrixx' stock price plunged on the day of the FDA's announcement, going from $18 to $6 in a matter of hours. Since then, the company has been struggling, largely because the pulled products were the company's best sellers, accounting for roughly half of the Scottsdale, Az.-based firm's sales.) The company assumed that it would be able to view and discuss whatever information the FDA had compiled that made the agency convinced that Zicam was so dangerous it needed to be ripped out of stores.
But in the past five months, Matrixx said it has become convinced that the FDA's promise of review was a sham and the agency is simply attempting to "create a post hoc rationalization for its position."
Matrixx added that the FDA has refused to provide any details of its scientific analysis leading to its conclusion that Zicam causes "anosmia" (loss of smell), despite the company filing several Freedom of Information Act requests.
"Matrixx is mystified as to why FDA will not share its analysis," the company's letter said. "Fundamental fairness dictates that when a federal agency unilaterally destroys the market for a product, at the very least it owes the affected company a clear explanation of its rationale..."
The letter adds that Matrixx had no warning of the ban before the FDA acted on June 16. The agency was aware of numerous loss of smell complaints dating back at least five years and conducted a series of health hazard evaluations in 2004 and 2005, but did not share the results with the company, according to the Matrixx filing. The fact that Zicam might be a subject of loss of smell complaints is not surprising because among the common causes of a loss of smell are the viral infections and colds that Zicam treats. Is it the Zicam or the cold?
The key to whether Zicam was the cause of some 800 reported loss-of-smell cases would seem to hinge on the FDA's investigation. But getting information on that investigation has proved impossible to date.
Those of you who have read my past post on this issue, know that I asked the agency to release its investigation on Zicam, presuming that the FDA must have some scientific study showing what harm the product causes or it wouldn't have banned it. Agency spokeswoman Siobhan DeLancey assured me that they did have such research. But I couldn't have it.
Or rather, to get it, I would have to file a Freedom of Information Act Request, which is a pretty standard government delaying tactic. DeLancey added that "there are a number of FOI requests that encompass this document, and they are currently in queue. Providing it out of queue would violate the regulations." I read that to say, "don't hold your breath."
Matrixx confirmed that impression. The company's vice president of marketing said Matrixx submitted a FOIA three months ago but is still waiting for the relevant documents. FOIA requests must generally be approved or denied within 20 days. Government agencies have an additional 10 days to provide the information after that. Why is it taking so long?
DeLancey responded to my questions, emailed late Thursday, with an email saying that she was out of the office today and I should contact another spokesman in their office. Two phone calls and one email to that spokesman have yet to be returned.
Meanwhile, the rest of the exhaustive Mattrixx filing appears to be a very long version of the National Law Review article written by Los Angeles attorney C. Dana Hobart, complaining that the science behind the loss of smell claims against Zicam have been rejected in every court (10 in all) that has looked at the evidence.
A few people who have commented on my other Zicam post have noted that the burden of proof in a legal proceeding is significant. There can be instances when a dangerous product can't be proved dangerous in a court. That is the FDA's job.
I'd agree, but I'm suspicious about the FDA's reluctance to open their research files showing what proof they have that the product is dangerous. If there is such research, why won't they provide it? If there's not, this important federal agency is serving as a shill for a vast and growing group of giddy plaintiff's attorneys, who figure they can use the FDA action to support their claims in court.