Generic Drug Approvals Up, Regs Down: Report

A PricewaterhouseCoopers Health Research Institute report says FDA approved 763 generic drugs in 2017, up 14% from the 651 approved the previous year. The Washington Examiner reports that a major reason for the increased number of generic drug approvals was the agency’s year-long effort to speed the generic drug pipeline through the GDUFA user fee program.

In addition, the Examiner says, FDA slowed its release of new regulations in 2017, releasing 40 regulations compared to 198 in 2016 and 152 in 2015, according to PricewaterhouseCoopers. The regulations figure covers all of FDA’s divisions and not just drugs, the report says. The number of regulations reportedly is the lowest since 2012, when 113 proposed regulations were released.

FDA issued 174 draft or final guidances for all FDA divisions and did not reduce the number of inspections compared to prior years, according to the report.