Health Canada deemed slow to assess drug safety

Health Canada is slow to assess potential safety issues when drug companies seek approval for new medications, according to a new report by the auditor general.

Interim Auditor GeneralJohn Wiersema said Tuesday that Health Canadacan take more than two years to complete an assessment of potential safety issues and provide Canadians with new safety information.

"Health Canada has not adequately fulfilled its key responsibilities for monitoring the safety of marketed drugs," the report concluded.

The regulatory recently took steps to actively monitor drug safety, the report said.

"In summary, we examined key Health Canada responsibilities involving timeliness, consistency, transparency, conflict of interest and risk-based post-market activities. We found that the Department has not adequately fulfilled most of these key responsibilities related to clinical trials, submission reviews, and post-market activities for pharmaceutical drugs," Wiersema's office wrote.

The concerns are important given that about 13,000 prescription and nonprescription drugs are on a Canadian market that were worth around $28 billion in 2008.

Wiersema also said Health Canada had also not acted on a long-standing commitment to disclose more information about the clinical trials it has approved.

"This increases the risk that Canadians may be unaware of new treatment options or may unknowingly participate in an unauthorized trial," he said.

The department received 4,400 drug submissions in 2009 and 2011. There are procedures to ensure drug reviews are consistent and high quality, the AG said, but the regulator hasn't assessed whether these are consistently interpreted and applied.

Changing drug labels

Health Canada said it agrees with the recommendations, such as taking more steps to strengthen how it oversees clinical trials by pharmaceutical companies with a risk-based approach. For example, officials said they monitored reports from companies testing the newest, riskiest drugs. But the focus may not be consistent, the AG's office said.

The report included case studies illustrating delays in communicating risk. For example, in 2006, the U.S. Food and Drug Administration publicly said the therapeutic effectiveness of daily low-dose acetylsalicylic acid (ASA) therapy was potentially reduced when ibuprofen was taken at the same time.

In September 2009, Health Canada finished its review and recommended that labels for products containing acetylsalicylic acid and ibuprofen be updated to inform Canadians of the new safety information. As of May, not all labels for the several hundred affected products had been updated, and Health Canada had not issued the recommended risk communication, the AG said.

In a statement responding to the report, Health Canada said it is already taking action to implement all 10 recommendations.

"It is important to note that the report did not question the safety or effectiveness of drugs authorized by Health Canada. Rather, it identified ways Health Canada can strengthen and improve processes that are already in place," the statement read.

Health Canada said it will invest new resources in more efficient drug product reviews, enhanced drug safety monitoring, and inspections using new user fees for industry that are now in place.

The Canadian Medical Association said patient safety is the toppriority of physicians and thefindings by the interim auditor general "deserve to be addressed."

The group has called for similar changes.