New US FDA Rules On Reporting Adverse Events

Following the deaths last year of five people in a US National Institutes of Health trial of fialuridine to treat hepatitis B, the Food and Drug Administration has announced plans for major changes in reporting requirements for adverse events associated with prescription drugs and biological products. The FDA says the NIH missed warning signs, including five earlier deaths in tests of fialuridine in 1990 and did not report incidents promptly; the NIH says there was no way to predict fialuridine's toxicity.

The changes are aimed at standardizing and speeding reporting of adverse reactions in clinical trials. They strengthen the Investigational New Drug regulations by requiring more frequent and complete reporting of possible problems, and set new requirements for safety surveillance of products already on the market.

Among the proposed changes relating to products in clinical trials are that: