Canada has announced a review of the communications efforts of its health regulator Health Canada after a review of the way it handled the recall of a birth-control drug.
Alysena 28, which is marketed by Apotex, was recalled last year after it was discovered that apparently faulty birth-control packages had been supplied to hundreds of thousands of Canadian women.
The government has since faced a media backlash over its perceived failure to properly communicate the situation to the public. This prompted Health Canada to commission Ottawa-based Risk Sciences International (RSI) to examine the recall.
RSI found that, while Health Canada followed all of its own recall procedures, communications could be improved in several areas. The Government of Canada has subsequently outlined a number of actions it will undertake, including:
- Exploring expanded recall powers
- Working with the pharma industry to ensure they give the government early notification of drug recalls
- Committing to doing an additional assessment of the impact of a drug recall on Canadians, in addition to the health risk assessments currently done according to internationally recognised scientific standards
- Strengthening Health Canada’s response to the most serious cases
- Clarifying and communicating the roles and responsibilities of the various parties involved in a recall situation
- Improving Health Canada’s risk communication procedures and making the language used in recalls more user-friendly.
“The review has provided timely and practical recommendations to further strengthen the Canadian drug recall system. We are committed to ensuring Canadians get the information they need, as quickly as possible,” said Rona Ambrose, minister of health.
Two class-action lawsuits have been filed against Apotex by women who allegedly became pregnant after taking placebos.