MHRA More Likely Than Other Regulators to Issue a Safety Advisory, Research Finds
A retrospective analysis of safety advisories issued by regulators in the US, Canada, UK and Australia from 2007 through 2016 revealed the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) was more likely than the others to issue an advisory, while the Australian Therapeutic Goods Administration (TGA) was least likely.The researchers from Australia and Canada, writing in JAMA Internal Medicine, explained how their analysis covered 1441 advisories in the four countries, covering 680 drug-risk issues. MHRA issued advisories for 344 of 657 drug-risk issues (52.4%) for medicines approved in the UK, Health Canada issued advisories for 317 of 635 drug-risk issues (49.9%), the US Food and Drug Administration (FDA) issued advisories for 265 of 647 drug-risk issues (41.0%) and the TGA issued advisories for 183 of 619 drug-risk issues (29.6%).
The researchers said the findings show “a low rate of agreement in decisions to inform professionals and the public of emergent safety concerns.”
“Our results likely reflect differences in national approaches to pharmacovigilance. National medicines policy determines the activities of the medicines regulator and resource availability, including the capacity to undertake postmarket monitoring and its administrative burden. Further study into the regulators’ decision making and action thresholds (based on seriousness of harm or strength of evidence) and the follow-on effects of these decisions and actions is required to fully elucidate the public health implications of these policies,” the researchers note.
Gerald Del Pan, director of FDA’s Office of Surveillance and Epidemiology, writes in a commentary related to the research that the authors raise important issues in addressing the concordance of safety advisories among regulators.
“However, it should perhaps not be surprising that safety advisories differ across regulatory authorities, in part because some authorities may have more than one type of advisory. Because the authors do not specify the details of the methods they used to identify safety advisories, the comparability in the safety advisories across the 4 regulatory authorities is difficult to assess,” he adds.
Del Pan also explains how the principal way of communicating new information about medicine safety is through an update to the medicine’s approved labeling and that each regulator has its own criteria for issuing additional safety advisories.
“Although regulatory agencies share information with each other about product-specific safety issues, the goal of such sharing is generally to exchange information and provide transparency with regard to rationale, so that each regulatory body can understand the bases for differing decisions and recommendations; transparency, rather than harmonized outcome, is the primary goal,” he notes.
Comparative Analysis of Medicines Safety Advisories Released by Australia, Canada, the United States, and the United Kingdom
Gauging the Effectiveness of Medicines Safety Communications From Global Regulatory Agencies