Jazz Pharma To FDA: What Patient Deaths?

Jazz Pharma To FDA: What Patient Deaths?

October 19th, 2011 // 12:38 pm @

Blaming your contracted distributor for failing to report serious adverse events, such as patient deaths, on a timely basis is probably not a sound strategy when offering explanations to the FDA. Consider Jazz Pharmaceuticals, which was tagged by the agency for failing to report at least 10 patient deaths, but insisted fault lay with its specialty distributor, which is a unit of Express Scripts.

Here’s the story: Last April and May, the FDA inspected Jazz facilities and discovered that the drugmaker had failed to report 74 serious and unexpected adverse events, including 10 patient deaths, concerning its Xyrem medication that is used to treat muscle weakness in people with sleep disorders. FDA regulations require that such reports to be filed within 15 days of initial receipt.

These reports, however, spanned from January 2003 to December 2010, and during the inspection, Janne Wissel, the Jazz senior vp and chief regulatory officer, acknowledged that the dates listed for 10 patient deaths did reflect when Jazz received the reports. But then the story changed, according to an October 11, 2011, warning letter the FDA sent to the drugmaker.

The letter states that in a May 20, 2011, response to the agency, the drugmaker “did not receive or have knowledge” of the adverse events until April 21, 2011. Why? Until then, Jazz argued the reports were held by Express Scripts Specialty Distribution Services, which is the exclusive Xyrem distributor that was contracted as the result of a Risk Evaluation and Mitigation Strategy, or REMS, that was imposed as part of the Xyrem approval in 2002 .

Jazz, which did not get around to filing the 74 adverse event reports with the FDA until May 5 of this year, then argued that, since its distributor had the information, the drugmaker should not be held responsible for failing to file the reports within the required 15-day mark. The agency, however, did not buy the explanation.

“We disagree with this position, given the exclusive and contractually specified role of (the distributor)in performing tasks required for meeting your legal obligations under the Xyrem REMS,” the FDA writes in its warning letter. The agency notes that the distributor is responsible for adverse event reporting and collecting per standard operating procedures .

We have asked Express Scripts for a comment and will update you accordingly.

Jazz, by the way, signed a corporate integrity agreement four years ago to resolve criminal and civil charges that Xyrem was marketed on an off-label basis by Orphan Medical, which the drugmaker acquired in 2005 (look here). The case became infamous because it involved one of the few instances in which a doctor, who was paid as a speaker by a drugmaker, was arrested and has, more recently, spawned a debate over commercial free speech.

Source: Pharmalot

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