29 December 2016 - In regard to your 23 December Editorial “The FDA Empire Strikes Back”.
The FDA process for drug evaluation and approval, as exhibited in the saga of the new drug eteplirsen for Duchenne muscular dystrophy, is beyond dysfunctional. After years of passionate advocacy for the unfortunate victims of this terrible disease finally leading to FDA approval, the insurance companies’ denial of drug coverage for a promising therapy is disheartening and unconscionable. Insurance companies have often delayed coverage until repetitive studies have determined that an effective therapy can no longer be administratively denied.