Matrixx Initiatives is suing FDA for the release of information related to the recall of its Zicam zinc-containing intranasal cold remedy products from the market.

Law firm Buc & Beardsley filed suit on behalf of Matrixx Dec. 22 in the U.S. District Court of the District of Columbia in an effort to obtain all records related to the agency's call for the removal of the firm's two top money-making products - a recall that continues to weigh down the company's revenues.

The Scottsdale, Ariz., firm sued after five unsuccessful attempts since June to obtain the records from FDA via the Freedom of Information Act. Over the same time period, an FDA task force has been working on an initiative to improve the agency's transparency.

Given the details Matrixx is seeking, it could be looking for fuel for further legal action against FDA to find the agency's decisions related to Zicam were improper or unfounded. The information could also help Matrixx steer clear of similar future problems.

More than half a year after its initial request Matrixx has been unable to obtain the records, which include all e-mails, press releases, phone calls and other documentation relating to the recall. The firm asks that the court mandate that FDA provide the records.

FDA called on Matrixx June 16 to recall Zicam Cold Remedy gel swabs and gel spray - which comprised 40 percent of the firm's sales - and simultaneously warned consumers of their risk potential.

FDA said an inspection turned up firm-collected adverse event reports showing a possible link to anosmia, or loss of smell. FDA also told Matrixx the reports should have been submitted to the agency as serious adverse events (¹ Also see "Zicam Case Shows FDA Takes Defining Adverse Events Seriously" - Pink Sheet, 22 June, 2009.).

Among other records, Matrixx sought via FOIA the "health hazard evaluation prepared by FDA" prior to the agency's June 16 request to recall the products and records of a June 18 Drug Safety Oversight Board meeting during which the products were discussed, according to the complaint.

Matrixx also asked FDA for the transcript of an Oct. 14 telephone call between its counsel and Douglas Throckmorton, then deputy director of the agency's drug center, about FDA's actions related to Zicam.

The firm would not comment on its interest in the records. Matrixx has yet to hear a response to the suit from FDA, executives said during a Jan. 27 fiscal 2010 third-quarter earnings call.

Food and drug attorney Ivan Wasserman, with Mannatt, Phelps & Phillips, noted FDA's "unilateral determination that the products present a health hazard has had a huge financial" impact, as well as an impact on Matrixx' reputation. "Whether FDA was right or wrong, the shocking thing is it appears that FDA has not shared the information that formed the basis of its determination with the company," Wasserman said.

"The fact that the company was forced to incur the additional expense of filing this lawsuit seems to add insult to injury, and certainly appears to go against FDA's recent statements that it wants to become more transparent," he said in an e-mail.

A. Wes Siegner, an attorney with Hyman, Phelps & McNamara, said if he were Matrixx's counsel he would also seek records pertaining to FDA's actions.

Siegner called it "odd" that the firm has yet to be provided with records, but, he added in FDA's defense, its FOI office is underfunded and receives many requests at a time with limited staff to respond.

He noted what FDA reported seemed a solid basis for its actions, but also said it may have been selective in what it made public.

"It's not unusual for the agency to do things, claiming the health hazard when there isn't one," Siegner maintained. His firm represented a french fry manufacturer in a suit against FDA to obtain records after the agency banned preservatives used in its products due to a possible link to deaths caused by an allergic reaction.

Siegner's firm successfully argued the deaths likely were not associated with the products. "The whole case fell apart," he said, adding the court granted his party a summary judgment.

Siegner noted that since FDA has not responded in the month since the suit was filed, litigation may take place. He speculated that FDA may cite from FOIA that there is an ongoing investigation and it cannot provide the records, or that some documents are internal documents and cannot be provided.

- Katie Stevenson ( ² k.stevenson@elsevier.com )

Matrixx Initiatives Files Suit Against FDA On Unanswered FOIA Grounds

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