More than a decade ago, the FDA issued its long-anticipated Final IND Safety Reporting Rule. It attempted to address the major problems sponsors and investigators faced with safety reporting.
It didn’t solve the problem of overreporting. Now, in 2021, overreporting is worse than ever. Rather than the expected 90% reduction in IND safety reports, the FDA and sites continue to receive more IND safety reports every year, Beales said.
Sponsors must do a better job analyzing suspected adverse events before sending out SUSARs. That’s not up for debate. The industry and regulators agree. “If you just report everything, you might miss something important. That could be a disaster,” said Temple.