November 2, 2018
Yesterday the Food and Drug Administration (FDA) announced that it would make important adverse event data public for the first time. This is excellent development for anyone who cares about good outcomes in the health care system. The decision follows CMS’s decision to make Medicare claims data public. These decisions provide helpful insight for the public (and fraud attorneys) into the goings on at drug companies and agencies.
The FDA’s new “Open FDA project” is designed to be a user-friendly web portal that allows investigators and consumers to research adverse event data reported to FDA after a drug or device has been on the market. The FDA encourages manufacturers to report adverse events to the agency for general oversight purposes, but does not require it. You can search the database by drug, by illness or disease state, and by type of reaction or outcome.
As whistleblower lawyers, of course this is hugely helpful, because an understanding of whether, for example, a company’s promotion of off-label uses of a drug or device has actually caused harm to patients is a critical component of the government’s evaluation of such a claim. Certainly, the (admittedly imperfect) database provides a sense of outcomes reported in the off-label arena.
Beyond our professional realm, this development is great for doctors and patients as well. For instance, patients can now investigate whether risky new therapies have any reported adverse events. Or they can ask their doctor why she’s recommending a therapy despite all these adverse events that have been reported.
Bravo FDA and CMS. Let the sunshine in. It can lead only to better decisions by patients, doctors, and investigators.