Fallout From FDAs Adverse Event Database

The Food and Drug Administration has launched a database of pharmaceutical adverse event reports, making nearly four million adverse event reports publicly accessible. The goals of the database, called “openFDA,” are to “spur innovation, advance academic research, educate the public, and protect public health,” according to the FDA. Faegre Baker Daniels attorney Demoya R. Gordon, in a Law360 article, notes the difference between a reported event and a scientific study, and sees a number of ancillary effects from openFDA, some of them beneficial and some problematic for the public or for pharmaceutical companies. She notes the information now being made available could contribute to misunderstanding among vaccine skeptics and others who don’t realize that a reported event does not indicate a causal link. As for litigation, adverse effect reports will no doubt be invoked by plaintiffs, as they had even before the database became available, and with mixed results. In some cases they have been rejected and in others they have received qualified acceptance. One potential benefit of openFDA: Companies could use the data to facilitate the development of personalized treatments for population subsets that have better outcomes and experience fewer side effects than the general population.