The bipartisan diabetes caucus wants answers

Leaders of the congressional diabetes caucus wrote to acting FDA Commissioner Ned Sharpless last week urging the agency to “take concrete, immediate steps to reduce or eliminate any hurdles associated with bringing lower-cost insulin to market.” More specifically, they’re asking for FDA to work with manufacturers to ensure lower-cost insulins aren’t delayed from coming to market because of a regulatory change set to go into effect in March that will change the specific way the drug is classified by the agency. 

If this feels like deja vu, it’s because it is: The FDA has long known about this issue. Not only could they read about it in STAT, but the caucus wrote a similar letter to the FDA in September 2017. But despite the pressure, the FDA largely hasn’t budged. Let’s see if another letter gets the FDA’s attention …