Adam Clark, Ph.D., Director of Federal and Scientific Affairs, FasterCures
In the world of drug development, there may be a tendency to believe the grass is always greener on the other side of the fence – or in the case of U.S. Food and Drug Administration, on the other side of the pond. Recent Congressional hearings have heard testimony on the slow pace of FDA approval of medical devices in the US compared to Europe.
A new study challenges these preconceptions and offers evidence that the FDA is in fact more efficient than its European counterpart in reviewing and approving new drug applications to bring new oncology drugs to market.
An analysis conducted by Friends of Cancer Research published in Health Affairs compared the review times of oncology drugs submitted to the FDA and the European Medicines Agency (EMA) between 2003 and 2010. The study showed that oncology drugs applications in the US were approved at approximately six months, while oncology drugs in Europe took nearly a year. In addition, this same study found that the FDA approved 32 oncology drugs over this time period compared to 26 by EMA.
Unfortunately for regulatory agencies like the FDA, it only makes headlines when something goes awry – safety alerts, food recalls, warning labels, and so forth. And headlines tend to shape public opinion, and in turn, could ultimately influence public policy. But the reality of the FDA’s task at-hand, regulating 25% of every consumer dollar is a tall order for any one agency. But there is no backstop, no other agency, that performs its critical work.
FasterCures is a member of the Alliance for a Stronger FDA, a broad-based coalition focused on ensuring Congress adequately funds FDA's essential missions. We need a strong and robust FDA to protect public health and safety and ensure the U.S. continues to pave the path to medical progress – and be able to apply lessons learned from cancer drug approvals across all other diseases.
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