Ranbaxy gets reprieve on atorvastatin recall

A New Jersey federal judge has saved Ranbaxy from a class action’s demand for a wider recall of its atorvastatin drug.

On November 9 last year, Ranbaxy initiated a voluntary recall of 41 lots of its generic atorvastatin calcium tablets (in 10, 20 and 40 mg doses), dispensed from September 25 onwards, “due to possible contamination with very small glass particles similar to the size of a grain of sand (less than 1mm in size)”, as the regulator FDA put it.

Yet, the patients concerned proposed a class action demand for a wider recall of the drug, implying a withdrawal even at the consumer level, not just at the retailer level.

The FDA determined that the recalled product posed no safety risk to the public and does not require a consumer-level product recall.

Ranbaxy then contended in the court that patients “are not entitled to a judicially mandated recall that would contradict the FDA’s expert judgment in advance of any judicial determination on the merits that a safety risk exists”.

Ranbaxy and its drug distributor Express Scripts, a pharmacy benefit manager, had argued that the court intervention would inappropriately intrude on the FDA’s jurisdiction and represent an affront to regulatory expertise.

The patients who had purchased the drug claimed they fell ill after consuming it. But Ranbaxy argued that their symptoms did not constitute post-consumption “illness” but were merely side-effects of the medication.

US District Judge Peter G Sheridan heard both sides,  and refused to grant a preliminary injunction that would extend the recall of atorvastatin from the retail level to the consumer level.

Ranbaxy officials did not respond to an email query seeking their views on the court’s order.

Meanwhile, it is believed the FDA might ask Ranbaxy to shift manufacture of atorvastatin from India to the US.

Should that come to pass, Ranbaxy’s margings would be affected, analysts said. For, the Indian facility is a low-cost site, and moving the activity to the US would inflate costs, particularly for a generic drug that has already seen a significant price erosion in the US market.

A Ranbaxy spokesperson declined comment.

This is the second time this year that Ranbaxy came under the scrutiny of the FDA. Prior, the issue was about manufacturing generic Lipitor in India.

@ramanakv