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The move is meant to improve transparency, but it may also increase the potential for public misinterpretation of adverse event data.
FDA announced yesterday it is making its enormous database of adverse event reports for foods, dietary supplements, and cosmetics publicly available on its website. The move, which currently includes data from 2004 through September 2016, is meant to improve transparency and increase awareness of adverse event reports, although some caution that the data could also be easily misinterpreted.
FDA’s adverse event data, which are obtained through FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System (CAERS), include reports submitted by consumers, health professionals, and others. Until now, the information was available to the public only through a Freedom of Information Act request. The newly available data files feature information, if provided, such as date of event, product role, reported brand/product name, industry code/name, reported symptom, outcome information, and demographic regarding the adverse event.
In addition to increasing transparency and providing more information to researchers and health care professionals, FDA says it is also releasing the adverse event data with the hope that it will “increase the number and completeness of the adverse event reports” it receives. Although the database includes both mandatory and voluntary reports, adverse event reports for dietary supplements are mandatory in instances when an event results in inpatient hospitalization, persistent or significant disability or incapacity, inpatient hospitalization, a congenital anomaly or birth defect, a life-threatening experience, or death. Supplement firms are required, under law, to submit serious adverse event reports to FDA no later than 15 business days after the company receives the report.
Data Without Context?
But along with improving transparency, FDA’s decision to make public the adverse event reports may also increase the potential for the public to misinterpret the data, warned the Council for Responsible Nutrition (CRN; Washington, DC), in a press statement. While CRN applauded FDA’s move to release the data in the name of transparency, it also urged the agency to provide context for its data so the public does not go too far in drawing its own conclusions.
“We advise the public to be cautious when reviewing these reports and to consider the fuller picture,” says Duffy MacKay, ND, senior vice president of scientific and regulatory affairs for CRN. “If consumers are looking to make decisions about safe or unsafe products, they would do best to pay attention to FDA’s consumer advisories, rather than looking at individual adverse event reports which, at the end of the day, may not be related to the supplement product.”
Indeed, FDA noted that reports in the CAERS database “only reflect information reported and do not represent any conclusion by FDA about whether the product actually caused the adverse event.” It also explained that adverse event reporting for dietary supplements may be underreported in some instances, despite being mandatory, and in other cases may reflect duplicate reporting if multiple people submit reports for the same adverse event.
Going forward, FDA intends to post CAERS data on a quarterly basis, with each posting made up of adverse event reports in the CAERS for the previous 3 months, with a delay of approximately one month. FDA’s full announcement of the move is available in the Federal Registerhere.
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