The Senate has confirmed Scott Gottlieb, MD, for the position of FDA Commissioner. Gottlieb faced some criticism from Democrats for his close ties to the pharmaceutical industry, but he promised to recuse himself from any FDA decisions relating to some 20 companies and institutions for 1 year.
The Senate has confirmed Scott Gottlieb, MD, for the position of FDA Commissioner by a vote of 57-42. Gottlieb faced some criticism from Democrats for his close ties to the pharmaceutical industry, but he promised to recuse himself from any FDA decisions relating to some 20 companies and institutions for 1 year.
Gottlieb succeeds Robert Califf, MD, who held the position for less than 1 year after being appointed by former President Barack Obama. Califf and his predecessor, Margaret A. Hamburg, MD, both came out in support for Gottlieb. Andy Slavitt, the former acting CMS administrator and another Obama appointee, had also approved of Gottlieb's nomination when the announcement was made in March.
Through his role at the FDA, Gottlieb will be expected to loosen regulatory restrictions to speed up the approval process. Ted Okon, executive director of the Community Oncology Alliance, said in an interview that Gottlieb is also a proponent of incrasing drug price transparency and revamping the drug rebate system.
Gottlieb has previous experience working for the agency. From 2005 to 2007 he was deputy commissioner for medical and scientific affairs.
The California Life Sciences Association (CSLA) applauded the confirmation and noted his track record for protecting public health and promoting innovation.
"With his experience in regulatory matters, and understanding of agency and industry needs, we are confident Dr Gottlieb will be an exemplary leader for the FDA," Sara Radcliffe, president and CEO of CLSA, said in a statement. "We look forward to working with him and his team at the FDA to meet our shared goals."
FDA Accepts Resubmitted NDA for Ataluren in Nonsense Duchenne Muscular Dystrophy
November 22nd 2024The new drug application (NDA) includes data from a global placebo-controlled, 72-week study as well as findings from the STRIDE registry, an ongoing, observational, real-world study of ataluren in routine care.
Read More