Establishment Fees Protect American Manufacturing, Mylan Argues In User Fee Proposal
Mylan President Heather Bresch is drawing attention to the economic implications of not inspecting overseas drug manufacturing facilities as she seeks congressional support for generic user fees to finance such activities.
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GMP quality, once Mylan's calling card, is now an ongoing problem, forcing product discontinuations and apologies to customers. Firm's valsartan products have European certificate of suitability suspended as Morgantown, W.Va. facility draws US FDA warning letter.
What began as an overseas recall of one lot made by a Pfizer subsidiary is expanding, threatening to besmirch Mylan’s once golden supply-chain quality record. The recall follows pricing controversy around the EpiPen product got the CEO hauled before Congress.
Pricing controversy around the product got the CEO hauled before Congress; now what began as an overseas recall of one lot made by a Pfizer subsidiary threatens to besmirch Mylan’s once golden supply chain quality record.