What is the cost of the long approval process for potentially life-saving drugs by the FDA? The approval process can take up to 12 years and cost $1 billion. But there are other costs. Patients arent able to take drugs that arent approved and they might die or become more ill. Another cost is that a potential drug maker might not want to take the financial risk of taking a drug to market. Powell recommends testing drugs but possibly making drugs "FDA recommended", rather than "FDA approved." Whats needed is competition and markets to help patients and entrepreneurs, says Powell.