Late Reports on Adverse Events Land Ariad Pharmaceuticals 483

Ariad Pharmaceuticals failed to submit a slew of adverse event reports within the 15-day deadline and follow the risk evaluation and mitigation strategy for its blockbuster leukemia drug Iclusig, prompting a 483.

During an October inspection of the company’s Cambridge, Mass., facility, investigators discovered various discrepancies with Ariad’s adverse event reports.

For instance, the drugmaker failed to submit to the FDA five reports within 15 days of initial receipt of the adverse event, in violation of agency regulations. In one instance, Ariad received a report on Oct. 15, 2013, and didn’t let FDA know until Dec. 20 of that year.

Field alert reports also were not submitted within three working days of identifying a problem with a batch, the FDA said in the six-observation form. Ariad failed to submit four FARs for batches that had foreign tablets, did not dissolve properly and contained the wrong amount of tablets.

Ariad also failed to follow up on two serious adverse events: one for a patient who experienced a stroke after taking Iclusig and another for a patient who was hospitalized.

And the drugmaker did not publish advertisements in medical journals throughout 2014, as required by Iclusig’s REMS. Ariad was required to publish ads in a journal during the second and third quarter of 2014. The company was also required to publish ads in a second journal in the third quarter. However, no ads were published during that time.

Ariad said it has responded to the FDA and is addressing the findings.

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