Study Finds Drug-Maker Side Effect Data Lacking

February 4, 2015 — Adverse event reports submitted to the FDA by drug-makers often lack basic information about the patient’s age, gender, and date of the incident, according to a study (PDF) published by the Institute for Safe Medication Practices (ISMP).

The FDA adverse event reporting system, FAERS, compiles reports of side effects that are voluntarily submitted by doctors and patients. Drug manufacturers are required by law to investigate and submit reports on all adverse events they receive.

Unfortunately, investigators found that 36% of manufacturer-submitted reports had no information about the patient’s age, 44% did not have an event date, and 50% of serious adverse event reports did not have age, gender, or a date.

The ISMP warned:

“To interact with a consumer or health professional about a serious adverse drug event without getting the patient’s age in 36% of the cases signals inadequate quality control and weak systems.”

The quality of side effect reports also varied widely depending on the manufacturer. Gilead Pharmaceuticals, the manufacturer of a Hepatitis C treatment Sovaldi, had basic information on only 39% of reports in the first three months of 2014. During the same time, 71% of reports on a competing medication called Incivek were “reasonably complete.”

In comparison, 85% of reports collected by the FDA met basic standards. Conclusions of the study were based on over 847,000 adverse event reports submitted in the 12-month period ending in March 2014.

The study is concerning because it suggests the FDA is not receiving valuable data it needs to adequately monitor patients safety — especially for generic drugs, adverse events in children, and birth defects.

The ISMP recommended modernizing the system, warning that it “badly needs a thorough overhaul, if not a comprehensive redesign.”