National regulatory agencies’ decisions to approve new drugs are based on limited safety evidence collected during clinical development. Often, only when a drug enters general use do rarer or longer-term adverse events become known or better understood, prompting regulators to issue safety advisories.1 We examined how often medicines regulators in 4 countries with similar medical traditions, population health, and demographics—Australia, Canada, the United Kingdom, and the United States—were concordant in their decisions to issue safety advisories on approved prescription medicines.
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Not all submitted comments are published. Please see our commenting policy for details.
Perry LT, Bhasale A, Fabbri A, et al. Comparative Analysis of Medicines Safety Advisories Released by Australia, Canada, the United States, and the United Kingdom. JAMA Intern Med. Published online April 29, 2019179(7):982–984. doi:10.1001/jamainternmed.2019.0294
Browse and subscribe to JAMA Network podcasts!
Customize your JAMA Network experience by selecting one or more topics from the list below.
Create a personal account or sign in to: