It is a common complaint among American doctors, researchers, and investors that the FDA takes much longer than its European counterpart to approve new drugs. However, a seven-year study just published in Health Affairs contradicts the assumption, having found that 23 out of 35 new cancer drugs debuted on the U.S. market before being cleared in Europe. Researchers from the nonprofit advocacy group Friends of Cancer Research analyzed regulatory review times for 35 new cancer drugs approved in the United States, Europe, or both, between 2003 and 2010. The researchers also found the FDA s review period of cancer medications to be typically shorter than its European counterpart: six months versus nearly one year. This certainly does defy the common wisdom that we re lagging behind in drug approval, says ACSH's Dr. Elizabeth Whelan. We re not.
When presented with the findings, the FDA s top drug official, Dr. Janet Woodcock, observed that the the real problems are in the scientific development programs and scientific uncertainty not the review process.