Health Canada's fast-tracked drug approvals "can put public at risk"

Drugs streamed into pharmaceutical regulator Health Canada's accelerated review process are more likely to be withdrawn from the market or earn a serious safety warning than those that undergo the standard review, according to a recent paper out of York University.

The study, published on-line by the Archives of Internal Medicine on October 8, is the first of its kind undertaken in Canada. It tracked a total of 434 new active substances (NASs) approved by Health Canada between 1995 and 2010, examining how many subsequently acquired either serious safety warnings or had to be withdrawn from the market for safety reasons. The NASs were then compared to see whether a difference in safety existed between those that had gone through Health Canada's standard 300 day review period vs. the 180 day priority process.

One in three priority-reviewed drugs risk later warnings or withdrawal