OIG questions effectiveness of REMS

HHS's Office of the Inspector General (OIG) said FDA does not have enough data to evaluate the agency's REMS program, which the OIG said raises concerns about the program's overall effectiveness. According to a report released on Wednesday, FDA has approved 199 REMS since the start of the program in 2008 through 2011 -- including 99 REMS that are still required. However, the OIG found that FDA does not have comprehensive data from sponsor assessments to determine whether the REMS are meeting their goals because the assessments are incomplete or include data that do not meet FDA's standards. Based on an evaluation of 49 REMS with limited information, the OIG found that only seven were meeting all of the goals of the REMS.

REMS can include restrictions on distribution and on conditions of use, including settings where drugs can be administered and/or who can prescribe them, as well as requirements that patients be monitored or enrolled in a registry. ...