As Alexion Announces New Recall of Soliris, Could FDA Scrutiny Return?

| 20 August 2013 |  By 

Alexion Pharmaceuticals has announced that one of its international subsidiaries has initiated a voluntary recall for the remaining vials of a single lot of Soliris (exulizumab), a drug intended to treat parozysmal nocturnal hemoglobinuria (PNH), after it said it was alerted to the presence of "visible particles" in a portion of the vials. But in light of recent regulatory scrutiny and emerging regulatory trends, could Alexion be in for additional scrutiny by US officials?

Alexion's Troubles Return

In an 8-K financial filing released on 20 August 2013, Alexion said the particles "were recently observed by [the company] as part of its routine testing of retained samples following vial filling, packaging, and labeling by a third party contract vialer that began performing services for Alexion in 2012."

The company said that while it "continues to analyze the relevant information to investigate the cause of this observation," the particulate matter is thought to potentially affect only 1-2% of vials produced on a per-month basis.

However, the recall could also garner the attention of regulators, including the US Food and Drug Administration, which in April 2013 had sent the company a Warning Letter alleging the presence of bacterial contamination in certain batches of its products manufactured at its Smithfield, Rhode Island facility.

FDA said it had a "general concern that Alexion had not implemented a robust quality system" to manufacture the active pharmaceutical ingredient in Soliris. An earlier 2011 Warning Letter to Alexion had made similar findings, FDA added.

At the time, Alexion wrote in an 8-K filing to investors that the company planned to manufacture the Soliris API at another FDA-approved location, but noted that the Warning Letter did not restrict shipments from the Smithfield facility.

A Focus on Contracting Facilities

However, as Regulatory Focus has recently noted, FDA has been taking a closer look at contracting facilities in recent months.

"Although your firm may contract out certain […] manufacturing operations, it cannot, by the same token, contract out its ultimate responsibility to ensure that the [products] it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with […] CGMP requirements," FDA wrote in several Warning Letters to dietary supplement manufacturers in 2013.

A more recent draft guidance document released by FDA, Contract Manufacturing Arrangements for Drugs: Quality Agreements, also expressed FDA's opinion that contract manufacturers must "work together to establish and maintain quality oversight of contracted manufacturing operations and the materials produced under contracted manufacturing arrangements."

Given Alexion's noted good manufacturing practice problems at its Rhode Island facility, where inspectors said at least six lots of Soliris API were contaminated with Bacillus thuringiensis to the extent that investigators were unable to count the exact number of colonies, investigators may well turn a critical eye to the company's contracted facilities as well.

Alexion 8-K Filing on Recall of Soliris


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