Study – Incomplete Adverse Event Reports by Drug Manufacturers


Adverse event reporting of injuries is of monumental value and importance for drugs approved by the FDA. These reports are the basis for modifications and even additions of new or supplemental warnings after drugs have been approved by the FDA and placed on the market.

Existing FDA regulations and guidance require drug manufacturers to submit two types of adverse event reports: (1) expedited reports, which must be made within 15 days of learning of a serious and unexpected side effect for which there is currently no warning on the drug label; and (2) periodic reports for adverse events that are serious but set forth as risks in the product label, which must be reported on a quarterly basis for the first three years after FDA approval.

According to a recent study published in the journal of Pharmacoepidemiology and Drug Safety, more than half of the adverse event reports made in 2014 by manufacturers to the Food and Drug Administration (“FDA”) were incomplete. In 2014, most of the reports are made by manufacturers (95.3%), with the remainder of adverse even reports being made by healthcare professionals and consumers (4.7%).

The usefulness of this adverse event reporting depends in large part on the completeness of the reports submitted to the FDA. The study found that only 40.4% of all expedited reports and 51.3% of the periodic reports made by drug manufactures in 2014 were considered “complete.” For purposes of the study, a “complete,” report must, at a minimum, include the user’s age, gender, event date and at least one medical term describing the adverse event. The vast majority of adverse events reported by drug manufacturers in 2014 omitted this basic information.

FDA regulations and guidance for adverse event reporting were created years ago (1997) and, according to the study, require updates to account for changing times. For instance, many manufacturers offer internet-based services directly to patients and healthcare professionals, such as 24-hour nurse hotlines, health insurance navigators and online instructions. Through these interactions, a manufacturer may learn of an adverse event but would not be required to report it until receiving confirmation from the healthcare professional that the drug played a role in the event. Therefore, as the study concluded, bringing the FDA regulations and guidance for adverse event reporting up to date would improve the usefulness of post-market surveillance in preventing future injuries and even death.

By: Rachel A. Sternlieb