Cavazzoni calls for ultrarare pathway at FDA, reforms to complex generics, biosimilars

The U.S. needs a new approval pathway for drugs that treat ultrarare diseases, Patrizia Cavazzoni, former director of FDA’s Center for Drug Evaluation and Research, believes. Speaking with BioCentury a few hours before her resignation came into effect on Friday, Cavazzoni said regulations and the law have failed to keep up with scientific progress in other areas, including approval requirements for biosimilars and complex generic drugs, as well as large-scale compounding and drug shortages.

Cavazzoni emphasized that she was describing her personal views based on seven years at FDA, including almost five years as CDER director or acting director. Her comments could resonate at FDA’s White Oak campus and on Capitol Hill as the Trump administration and Republican majorities in Congress look for opportunities to modernize and streamline regulation. ...