For emphasis: the entire universe of drugs that other regulators approved and FDA didn’t represents one approved drug in ten. Acomplia, from Sanofi, was supposed to be a treatment for obesity and heart disease risk, but it increased the risk of suicidal behavior. Risks sometimes emerge with rare disease drugs, too. The FDA already seems to be willing to make a bet on rare disease drugs that have less data behind them, in part because of pressure from Congress. Rare disease drugs, like the one Megan Crowley takes or Exondys, cost upward of $300,000 per patient per year.

Source: Forbes March 01, 2017 17:54 UTC