One of Gottlieb’s priorities will likely be to streamline the process for approving generic versions of complex, difficult-to-copy therapeutics. He has stated publicly that he does not believe the FDA has good tools or policies to move such products and has advocated the creation of different approval standards.
“He’s a thoughtful and nuanced kind of guy, and not solely an industry shill,” said Jim Shehan, head of Lowenstein Sandler’s FDA regulatory practice.
A survey conducted by Mizuho Securities USA Inc. of 53 pharmaceutical executives found that 72 percent favored Gottlieb over other potential candidates. Many described him as knowledgeable, experienced and balanced.
“Gottlieb is someone who the industry and investors view as an incremental positive,” said RBC Capital Markets analyst Michael Yee. “The industry and investors need rational scientific logic and an understanding of risks and benefits.”
Patient advocates welcomed the news.
Gottlieb “has firsthand experience at the FDA and as a physician that has treated patients understands the breadth of work that needs to be achieved on their behalf,” said Ellen Sigal, founder of Friends of Cancer Research.
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