In 2008, the U.S. Food and Drug Administration developed the term “breakthrough designation” to review drugs that could substantially improve existing treatments faster. However, a recent study shows that doctors often misinterpret the meaning, resulting in an efficient marketing tool for pharmaceutical companies.
A research letter that was published in the Journal of the American Medical Association showed that over half of the 700 physicians surveyed, incorrectly believed that to obtain a breakthrough designation, strong evidence is required. In reality, the FDA only requires preliminary evidence. About 64% of physicians who responded also incorrectly answered that these drugs represented a major advance.
These findings were published in the Journal of the American Medical Association on April 12, 2016.