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June 19, 2012 4:55 pm

Jazz Pharmaceuticals could see FDA reinspection this year, related to its Xyrem adverse event reporting – experts

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This article is provided to FT.com readers by BioPharm Insight—a news service focused on providing insight into the most price sensitive issues in the global pharmaceutical market. www.biopharminsight.com

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Jazz Pharmaceuticals (NASDAQ:JAZZ) could very possibly face an FDA reinspection in the next six months, if not sooner, concerning its underreporting of serious adverse events (SAEs), said three regulatory compliance consultants. They added that the company should be reviewing its records and auditing its contract pharmacy.

The company first received an FDA warning letter in October 2011, after failure to properly submit reports and develop adequate written procedures on SAEs related to its drug Xyrem (sodium oxybate) for narcolepsy.

The company recently disclosed that it had received an FDA Form 483 following an FDA inspection of its Palo Alto, California, facility conducted in late May. The investigators observed Jazz’s incomplete review of its contractor Express Scripts Specialty Distribution Services’ (ESSDS) information related to potential adverse events prior to 2011, and an incomplete determination of whether there are more adverse events that are required to be reported to the FDA. The form also documented Jazz’s insufficient documentation to show its past SAEs investigation and its lack of a written procedure relating to one administrative aspect of its current drug safety monitoring procedures.

A company spokesperson deferred all questions to the recent Form 8-K filed with the US Securities and Exchange Commission on 4 June.

The Form 8-K states that Jazz intends to respond to the Form 483 “in a timely manner and we anticipate that we will be able to promptly complete the actions that we believe are required to address the matters raised” in an October 2011 warning letter and the Form 483 observations. The company also noted that it “cannot predict the final outcome of the FDA’s regulatory compliance review, or the timing thereof.”

The FDA expects a response in about 15 days, the consultants agreed.

Considering adverse events are a “hot button” topic at the FDA, a follow-up FDA inspection could be as soon as six months or less, said one consultant.

Warning letters related to adverse events are fairly rare, said a second consultant and former FDA compliance official, so for Jazz to receive one is “pretty bad.” Considering the gravity of the events, six months for reinspection may be “generous,” he said, but much will depend on what corrective actions Jazz has done and what other enforcement actions the district office is juggling.

A third consultant agreed a reinspection will likely happen in about six months, but it may take up to a year depending on the agency district, manpower and budget requirements.

Among the actions that Jazz should do include a review of its SAE records for accuracy and reliability, reconsider questionnaire measures used to capture adverse events, or redefine SAEs and AEs and the relation to the drug, the first consultant said.

The warning letter indicates that Jazz has had longstanding regulatory problems in recording timely AE reports, dating back to 2003, the third consultant said. He noted it is Jazz’s responsibility to audit the contract pharmacy’s actions to be in compliance. The Form 483 indicates the company has not prepared proper written protocols on retraining to any depth to prevent violations of the law to continue, he said.

The company responded to the 2011 warning letter and provided an update in January 2012, advising the agency of its corrective actions, including its investigation of ESSDS information on adverse events, according to the Form 8-K.

“This further investigation of data from the historical period is continuing and while, in our assessment, the results of our preliminary work with respect to the analysis are consistent with the previously known safety profile of Xyrem, we cannot predict the final outcome of this investigation,” the Form 8-K states. “We have strengthened our procedures and are continuing to take appropriate corrective actions to address the matters covered in the warning letter.”

The FDA is not obligated to provide guidance as to the corrective actions the company should do, the consultants agreed.

The FDA does not have to reply to the company’s response to the 483 but many times it will, the first consultant said. The agency could respond in kind that the company has addressed its issues and that it will verify during the next inspection, he noted.

Jazz’s market cap is USD 2.4bn.

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