FDA sends warning letter to Mylan over 'inadequate' manufacturing processes at India plant
Mylan has once again run afoul of the FDA over its lack of upkeep at manufacturing plants.
For the second time in the last 12 months, the agency has sent a warning letter to the generic drugmaker calling out its failure to maintain industry-standard cleaning procedures that prevent contamination. In the letter, sent on Aug. 20 and published Tuesday, regulators also allege Mylan $MYL did not test incoming API for impurities, have mechanisms in place to detect such impurities from entering products, or keep cleaning records for bulk storage tanks.
The FDA’s concerns arose during an inspection at a plant in India last February.
“These repeated failures at multiple sites manufacturing API demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate,” wrote Francis Godwin, the director of the FDA’s Office of Manufacturing Quality and Office of Compliance at the Center for Drug Evaluation and Research.
Godwin also told Mylan, “You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements at all your sites.”
Investors reacted somewhat poorly to the news, sending Mylan shares down about 5% in Tuesday trading. The stock showed a slight rebound early Wednesday, hovering around a 1.5% increase.
Mylan responded with a statement saying that it does not foresee any interruptions to occur regarding manufacturing or distribution, as there are no “significant” launches coming out of the plant through the end of the year. “No significant commercial impact is expected,” Mylan said, and noted that after a previous warning letter sent in November 2019, the company “put additional controls, corrective actions and improvements in place.”
“Importantly, extensive testing of APIs manufactured and distributed by the site was performed for the presence of nitrosamine impurities and no evidence of cross contamination was identified,” the statement went on.
That November letter ultimately prompted the February inspections after the FDA found “poor control” of solvents at a separate manufacturing plant in India. Godwin wrote at the time that similar substandard cleaning practices and impurity testing allegedly took place.
The warning letter puts a dent in a largely successful last few months for Mylan, which in late July earned a win in the courts as an injunction blocking its Tecfidera generic was lifted. Though the company would still be filing for an approval at-risk, given that Tecfidera maker Biogen is appealing, Mylan has asked the FDA to move up its PDUFA date from November.
Tecfidera racked up $4.4 billion in 2019 sales for Biogen, and if even some of that pie heads Mylan’s way, it could see a significant windfall.