In a split vote, the Senate confirmed the nomination of Scott Gottlieb as the next head of the FDA. Gottlieb emphasized the need to take action to accelerate the market entry of generics and biosimilars and said the implementation of the Cures Act is a top priority.
The Senate voted 57-42 in favor of confirming Dr. Scott Gottlieb as FDA commissioner. Gottlieb is a partner at venture capital firm New Enterprise Associates, a longtime healthcare investor and consultant, and a resident fellow at the American Enterprise Institute. He formerly served in several senior roles at the FDA, including deputy commissioner for medical and scientific affairs (2005-2007) and director of medical policy development (2003-2004). Prior to his confirmation, Gottlieb agreed to divest his holdings in nearly two dozen healthcare stocks and resign from multiple corporate boards and consulting positions.
In his first remarks as commissioner, Gottlieb said that while the FDA doesn’t play a direct role in drug pricing, it can take meaningful steps in the regulation of generics and biosimilars to ensure low-cost alternatives get to market quicker. He said the agency can take steps to ensure the generic drug process isn’t inaptly “gamed” to interrupt competition.
He also said the 21st Century Cures Act gives the agency a clear mandate to be “forward-leaning” in the assessment of safety and efficacy. He stressed that implementation of the act is a key priority, noting that the agency needs to regulate areas of new technology in a manner that doesn’t increase the cost of development or stifle innovation.
Gottlieb also said the FDA has an opportunity to improve its public health protection role under a restructuring of the Office of Regulatory Affairs (ORA). The new ORA structure will shed regional breakdowns in favor of teams organized within specialist offices focused on pharmaceutical quality, medical devices, tobacco, food and biologic drugs.
To conclude, Gottlieb said the FDA’s initiatives need to be risk-based and ensure the agency gets the most “public health bang” for its efforts and resources. He also said the agency needs to be patient-centric and science-based while maintaining the gold standard for regulatory science and science-led decision-making.