Drug Manufacturers Underreporting Medication’s Side Effects, Report Finds

According to a new study conducted by the Institute for Safe Medication Practices, the main mechanism for tracking and documenting serious side effects associated with medications is deeply flawed, according to The New York Times (“Drug Maker’s Data on Side Effects Is Called Lacking in a Report,” Feb. 2, 2015). The study found that this problem is attributable to drug manufacturers themselves, alleging that these companies are submitting incomplete information in the reports to the Food and Drug Administration (FDA), The New York Times reported. It is not that medication manufacturers are not submitting such reports to the FDA, but that reports do not meet the basic standards for completeness in that they omit the patient’s age, sex and the date of the event complained of, according to The New York Times. This information is critical to the FDA for proper evaluation of how drugs affect specific groups of people, according to the Wall Street Journal. Drug manufacturers are required to disclose to the FDA each and every instance that comes to their attention of an adverse event attributable to a drug they manufacture under FDA rules. However, less than half of reports filed are considered “complete” under FDA standards, the Wall Street Journal reported. While a few companies were commended by the FDA for consistently submitting high quality reports, many others were condemned for a complete lack of due diligence, according to The New York Times story. Manufacturers responded to these allegations by claiming that the lack of information is attributable to the fact that consumers and/or doctors are not directly filing reports to the manufacturers, but instead the companies are left learning of the complications from medical literature that does not always contain the information the FDA claims is lacking, according to The New York Times.