PhRMA Slams FDA Semi-Annual ADR Report Plan

The Pharmaceutical and Research Manufacturers of America says the Food and Drug Administration's estimate of costs to the industry of $24.03 million a year to comply with its proposed rule on Adverse Experience Reporting Requirements for Human Drug and Licensed Biological Products is "grossly understated," and that the real annual cost "will be a multiple of that."

It also says the proposal is of sufficient magnitude to warrant the setting-up of a pilot program to test whether it will, in fact, assist in achieving a greater level of safety in drug development. The proposal was published on October 27, 1994, with comments requested by January 25.

The FDA proposes to add to the annual reporting requirements a semi-annual report of all deaths, serious adverse experiences and study discontinuations resulting from an adverse experience, whether expected or not, and whether or not there was thought to be a possibility that the problem was caused by the drug. This change, it says, "is intended to ensure that reports of deaths and other serious adverse experiences in all clinical studies are collected and reviewed in a timely and comprehensive manner, and the possibility of drug relatedness is always considered."