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Gottlieb Nomination As US FDA Chief Could Signal Changes To Generic Approval Process

 
• By Michael Cipriano

Former deputy commissioner will also likely push increased use of biomarkers and more flexibility in off-label communication, among other reforms.

President Donald Trump's choice of Scott Gottlieb to head the US FDA could signal efforts to bring reforms among a variety of fronts, perhaps none more notable than how the agency approves generic drugs.

Gottlieb, returning for what would be his third stint at the agency, has been a staunch proponent for flexible approval pathways, and despite some ominous tweets, the Trump Administration has made speeding ANDA clearance (rather than direct government intervention) the central focus of its drug pricing policy efforts

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