FDA's deadline problem?

More drugs are approved in December than any other time of year, but those approvals are later associated with more hospitalizations, life-threatening events, and deaths, according to a new study.

More drugs are approved in December than any other time of year, but those approvals are later associated with more hospitalizations, life-threatening events, and deaths, according to a new study. "We see about twice as many adverse events," says Lauren Cohen, a professor of finance and entrepreneurial management at Harvard Business School who, with colleagues at MIT and the University of Texas at Dallas, documented the pattern. They found similar issues, along with the same safety implications, at the end of each month. The surges, they say, are not driven by explicit deadlines, leading the researchers to conclude the increases may be motivated by self-imposed "desk-clearing" benchmarks. FDA acknowledges the December increase but says the pattern has diminished in recent years. "We were seeing almost 40% of approvals happening in December in the 1980s and ’90s," says FDA spokesman Nathan Arnold. "If you just look since the Prescription Drug User Fee Act was approved in 1992, it’s a much more even distribution."