Canada waiting for another Vioxx?
Yesterday when I blogged about new product safety regulations unveiled by Prime Minister Stephen Harper, I commented that the changes
Yesterday when I blogged about new product safety regulations unveiled by Prime Minister Stephen Harper, I commented that the changes to the drug approval process sounded like another Vioxx or Avandia debacle waiting to happen. Both highly-touted drugs were linked to deadly side effects after they reached the market; Vioxx was subsequently shelved while Avandia sales have plunged.
The new rules will see fewer testing requirements before new drugs are put on the market, and more post-approval assessment.
While Health Minister Tony Clement is quoted in article in The Globe and Mail as saying he assures the government is “not going to change our standards or change our stringent review,” the article quotes a number of experts concerned the changes are “dangerous.”
Their concerns are backed by a study published in the New England Journal of Medicine last month that found that drugs that are fast-tracked through the approvals system are more likely to face recalls and safety problems.