Mylan aims to address FDA warning letter in next 6 months

By Nick Taylor

- Last updated on GMT

(Image: Getty/BrianAJackson)
(Image: Getty/BrianAJackson)

Related tags: Mylan, US FDA, Warning letter

Mylan sets sights on addressing US FDA warning letter in the ‘next quarter or a couple of quarters.’

In November 2018, the US Food and Drug Administration (FDA) sent a warning letter​ detailing quality problems at Mylan’s facility in Morgantown, West Virginia. The warning letter described problems, such as the failure to adequately clean and sterilize equipment and utensils.

Around one year after receiving the warning letter, and more than 18 months after the inspection that triggered it, Mylan’ president, Rajiv Malik, thinks the company is now closing in on the resolution of the situation.

Talking at a recent investor conference, Malik said, “We always said, we are not in a rush. We wanted this fix to be a sustainable fix. We have taken our time to rationalize and simplify the facility, we are closely working with the FDA and, over next quarter or a couple of quarters, we should be able to address this​.”

The rationalization and simplification referred to by Malik entailed slashing the number of products made at the facility. At one point, the Morgantown plant manufactured around 300 products. Today, that figure is down to around 100.

Malik said Mylan spent 18 months reducing the number of products in the belief “any remediation on Morgantown would not have been sustainable unless we would have simplified the facility and removed the complexity​.”

With the simplification process now complete, Mylan is focused on addressing the FDA’s concerns and getting the warning letter closed out.

Mylan thinks it can resolve the situation in the coming months. Even if it takes longer than that to resolve, the warning letter is unlikely to have a big effect on Mylan’s performance.

The warning letter could theoretically impede Mylan’s efforts to introduce new products made at Morgantown but no launches that rely on the facility are scheduled for the next few years. Similarly, Mylan has not had to put any existing pipeline opportunities on pause because of the warning letter.

Malik also expects a more recent warning letter​ targeting an active pharmaceutical ingredient (API) facility to have no impact on revenues next year. The FDA sent the warning letter after its inspectors found the Indian facility lacked procedures for stopping contamination with N-nitrosodimethylamine and N-nitrosodiethylamine, the carcinogens behind recalls of sartan​ and ranitidine​ medicines.

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