Insights professionals are often responsible for reporting adverse events from pharmaceuticals or medical devices when they are uncovered during healthcare market research.
Even outside of clinical trials, research subjects could mention health effects that may be associated with a drug or device, and the insights industry has a supporting role to play (legally and ethically) in detecting safety problems. Many pharmaceutical and device manufacturers and providers are required by their own heavy regulations to collect safety information in all environments and interactions, including healthcare market research.
Different laws and regulations (e.g., the Food Drug and Cosmetic Act, vaccine safety laws, Medicare and Medicaid certification rules, etc.) require the reporting of adverse events. Sometimes it is required just by manufacturers, but it can also rope in healthcare professionals, and researchers.
Whatever reporting (or other pharmacovigilance) obligations may apply, they should be ironed out between the parties before any market research begins.
For specific guidance, the Insights Association generally refers members to EPHMRA’s 2025 Adverse Event Reporting Guidelines.
“Adverse event” means “an unintended and [unfavorable] response to a medicine, whether considered to be related to the medicine or medical device (i.e., causal relationship).”
The term “adverse reaction” is used instead if “it is reasonable to assume a causal relationship with a medicinal product,” but it is up to the entities legally responsible for the drugs or devices to make such a determination.
About the Author
Based in Washington, DC, Howard is the Insights Association's lobbyist for the marketing research and data analytics industry, focusing primarily on consumer privacy and data security, the Telephone Consumer Protection Act (TCPA), tort reform, and the funding and integrity of the decennial Census and the American Community Survey (ACS).
Howard has more than two decades of public policy experience. Before the Insights Association, he worked in Congress as senior legislative staffer for then-Representatives Christopher Cox (CA-48) and Cliff Stearns (FL-06). He also served more than four years with a science policy think tank, working to improve the understanding of scientific and social research and methodology among journalists and policymakers.
Howard is also co-director of The Census Project, a 900+ member coalition in support of a fair and accurate Census and ACS.
He has also served previously on the Board of Directors for the National Institute for Lobbying and Ethics and and the Association of Government Relations Professionals.
Howard has an MA International Relations from the University of Essex in England and a BA Honors Political Studies from Trent University in Canada, and has obtained the Certified Association Executive (CAE), Professional Lobbying Certificate (PLC) and the Public Policy Certificate (PPC).
When not running advocacy for the Insights Association, Howard enjoys hockey, NFL football, sci-fi and horror movies, playing with his dog, and spending time with family and friends.