Facts and Figures: REMS by the Numbers

2008

The year the Food and Drug Administration’s authority to require REMS programs went into effect

1161

Brand drugs approved by the FDA as of January 2015

1027

Number of generic drugs approved by FDA in 2017

200+

Number of REMS FDA released from the 222 original REMS programs approved in 2008 (https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsData.page)

61

Number of REMS programs approved for all medicines now on the market (https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsData.page)

51

Number of REMS with “Elements to Assure Safe Use” restrictions (https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm)

39

Medical conditions and interventions benefitting from medicines carrying strict REMS safeguards

30

Average number of novel drugs FDA approved annually between 2007 and 2015

13

Classes of drugs managed through a “shared” REMS system (https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm)