Understanding FDA Patient Experience Data Use
Of 59 new molecular entities approved by FDA in 2018, 48 included a table summarizing whether patient experience data (PED) was used during the agency drug review. Some 71% of the 48 approvals reported using PED in the review, with patient-reported outcomes the most significant source of PED.
Sanofi researchers say they are reporting on use of PED as a first step to better understanding how the agency considers PED in regulatory decision making. “This analysis should help develop a baseline regarding FDA use of PED and may inform decisions to ensure patients’ experiences are adequately heard in future drug development,” the researchers write in Therapeutic Innovation & Regulatory Science.
The article says that going forward, the authors expect that FDA review divisions’ use of a table describing PED use would become more standardized. They also discuss the format of the public statement required under the 21st Century Cures Act.