After assessing its response to an April recall, Health Canada is considering requiring drugmakers to notify the agency about emerging risks of marketed drugs before recalls are made.
Such a requirement would ensure Health Canada would fully engage in a company’s risk assessment and help the agency take the most appropriate action, reads a new report prepared for the regulator. Currently, drugmakers must notify Health Canada within 24 hours of making a recall decision.
The report, prepared by Ottawa-based Risk Sciences International (RSI), goes on to also recommend Health Canada improve the clarity of its communications and its capacity to more promptly respond to drug safety issues.
The RSI report evaluates the agency’s response to a recall of Apotex’s contraceptive drug Alysena 28 (levonorgestrel and ethinyl estradiol tablets, USP), pulled from market shelves in April due to blister packs having too many placebos, which could cause an unplanned pregnancy.
Due to several factors, Health Canada didn’t publicize the recall until almost a week after Apotex initiated the market correction — a voluntary Type I (the most serious) and Type II recall.
Apotex’s actions fell short, but it’s not easy to prove the company didn’t comply with the “current imprecise regulatory requirement” in Canada, the report states. Existing law does not provide Health Canada with clear definitions of the requirements it is to enforce, or with the powers necessary to enforce them, it adds.
As in the U.S., regulators in Canada do not have the power to order a mandatory recall, and recall regulations in both countries pertain only to recalls initiated voluntarily by a drugmaker.
Health Canada said it has accepted the report’s recommendations, and outlined several actions in response, including doing an additional assessment to consider the impact a drug recall could have on Canadians, in addition to the current health risk assessments presently done.
View RSI’s report at www.fdanews.com/ext/files/10-16-13-Canada.pdf. — Nick Otto