Drug recalls linked to U.S. testing deadlines

From the Globe and Mail:
New drugs that are rushed through the approval process to meet government-imposed deadlines in the United States are much more likely to be the subject of recalls and safety problems, reveals a new study that sheds light on how these constraints affect decisions made by health officials.

Working within rigid deadlines may put too much pressure on health regulators, compromising their ability to focus adequate attention on the safety and efficacy of the drug, as well as the quality of clinical data submitted by the pharmaceutical company, according to the study published today in the New England Journal of Medicine.

"Deadlines are a part of life and they do a lot," said Daniel Carpenter, professor of government at Harvard University and lead author of the study. "The question is should we be relying so heavily on deadlines, or could we rely a little bit less on deadlines and a little more on resources?" ...more