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Mylan’s Autor-de-Force Move into Quality “Differentiation” and Sterile Injectables

 
• By Cole Werble

Mylan is investing heavily to create a competitive advantage based on manufacturing quality – and public policy. The firm’s recruitment of FDA’s Deborah Autor highlights a strategy to spend more on quality while aiming at higher margins, especially in sterile injectables where the company sees an opening after widespread quality breakdowns across the industry.

Mylan NV is adding FDA’s top cop and top international negotiator, Deputy Commissioner for Regulatory Affairs Deborah Autor, to lead the generic company’s strategic response to the opportunities opening up following enactment of the Food & Drug Administration Safety & Innovation Act.

Typically, the recruitment of someone from the government compliance sector (FDA inspectors, Justice Department prosecutors, etc.) is defensive – a response by a company to lingering quality issues. In Mylan’s...

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