Fresenius Alleges Akorn Knowingly Submitted Fraudulent Testing Data to FDA

Regulatory NewsRegulatory News | 02 May 2018 |  By 

Details on why Fresenius last month sought to terminate its acquisition of Akorn, Inc. emerged on Wednesday, with Fresenius alleging a top executive at Akorn had knowingly submitted fabricated data to the US Food and Drug Administration (FDA).

Fresenius alleged, according to Reuters, that an Akorn executive vice president for quality assurance in 2012 knowingly directed the submission of fraudulent testing data to FDA as part of an application to market the antibiotic azithromycin.

Fresenius said its investigation revealed “blatant fraud at the very top level of Akorn’s executive team, stunning evidence of blatant and pervasive data integrity violations,” according to Reuters, citing court documents released Tuesday.

Fresenius on 22 April also publicly announced that its independent investigation found “material breaches of FDA data integrity requirements relating to Akorn's operations.” 

Last week, however, Akorn asked the Delaware court to require Fresenius to fulfill its obligations under the $4.3 billion merger agreement, noting, “Fresenius’ attempt to terminate the transaction on the pretext that the findings from the ongoing investigation are a breach of the merger agreement is completely without merit.

“The previously disclosed ongoing investigation, of which we have voluntarily notified and are in regular communication with the Food and Drug Administration, has not found any facts that would result in a material adverse effect on Akorn’s business and therefore there is no basis to terminate the transaction. The investigation is not a condition to closing and the only remaining condition is approval from the Federal Trade Commission,” Akorn said in a statement.

FDA in 2016 sent a Form 483 to Akorn’s Illinois-based sterile manufacturing facility, with six observations on quality control, deviations from written procedures and a failure to investigate batch failures. Akorn’s India-based manufacturing facility also has been on import alert since 2015.


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