A well-run FDA is crucial to ensuring that Americans continue to get access to the best new therapies in a timely fashion. Lengthy and costly approval periods–which average 10 years and $1 billion per product under consideration–raise important questions about whether the FDA is doing its part to make sure innovative new therapies can reach patients who need them.
According to a recent article in Forbes, “negative media and congressional attention exacerbate this problem and can make the agency reluctant to grant final approval to new products. In fact, there is some evidence that approvals of products in Phase III, the last level of assessment before products go to market, has declined in recent years–indicating that FDA officials may be nervous about the folks who are looking over their shoulders. This timidity has been particularly worrisome when it comes to approving new cancer drugs as well as antibiotics, which are needed to combat increasingly resistant infections contracted during hospital stays.”
With an already stretched budget and talk of expanding the FDA’s role, the new commissioners (President Obama has reportedly selected Margaret Hamburg and Joshua Sharfstein to serve as commissioner and deputy commissioner, respectively) face a big challenge.