Health Canada Taking too Long to Review on Safety Concerns about Drugs on the Market: Auditor General

Abstract

Health Canada takes too long to assess and publicly communicate on potential safety issues with pharmaceuticals once they are on the market, according to the annual fall report from the Auditor General of Canada. In the report tabled in the House of Commons November 22, 2011, Interim Auditor General John Wiersema said the Federal Health Department frequently takes up to 2 years to complete postmarket reviews of possible safety concerns and to provide updated safety information to Canadians. “It needs to get safety information out to Canadians more quickly,” he said in a news release. The audit also pointed to Health Canada's lack of transparency in decision-making — for example, not disclosing information on drug submissions that it has rejected or information on the status of the drugs it has approved with conditions. In addition, said the report, the department has failed to act on a long-standing commitment to release more information about clinical trials it has authorized, stating, “This increases the risk that Canadians may be unaware of new treatment options or may unknowingly participate in an unauthorized trial.” The audit flagged the case of parents who had enrolled their child in a trial advertised as being authorized by Health Canada; they later complained to Health Canada about their concerns about the trial and learned it had not been authorized by the regulator. The Auditor General made 10 recommendations targeted at improving Health Canada's timeliness and transparency and the department has agreed to implement all of them. The report's audit of Health Canada's regulation of pharmaceutical drugs is available at www.oag-bvg.gc.ca/internet/English/parl_oag_201111_04_e_35936.html#hd3a.