Gottlieb Shifts From Regulatory To Reimbursement Focus In One Of First Post-Commissioner Appearances
CAR-T reimbursement is concern for former US FDA commissioner Scott Gottlieb in speech at the National Press Club.
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CDER director lobbied for inclusion of a 505(b)(2)-like category for biologics, but it was ultimately not included in the 2010 legislation creating the biosimilar pathway; Woodcock urges patience on the development of the biosimilar marketplace and notes the agency will be keeping an eye on the development of biobetters, which are relatively new innovations.
Change would increase maximum new technology add-on payments from 50% to 65% of costs.
Without constraints of being FDA commissioner, Gottlieb will have podium to push for changes to drug pricing and competition.