Yesterday the Food and Drug Administration (“FDA”) announced that it is making an important set of data about “adverse events” public for the first time. This is excellent development for anyone who cares about good outcomes in the health care system. The decision follows on the heels of the decision by the Center for Medicare and Medicaid Services (“CMS”) to make large portions of the Medicare claims data base public. Taken together, these two agency decisions will provide far greater insight for the public (and for anti-fraud attorneys like us) in what’s going on behind the curtains at drug companies and at federal 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 events that have occurred and been reported to FDA after a drug or device has been on the market. (Manufacturers are encouraged but not required to report adverse events to the agency for general oversight purposes, which can in some cases lead to a drug or device’s recall.) You can search the data base 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. By being able to look into the (admittedly imperfect) data base of adverse events, investigators can get at least an impressionistic look at the kinds of outcomes have been reported in the off-label arena. Beyond our professional realm, this development is great for doctors and patients as well. If you as a patient were to be recommended a risky new therapy by a physician, wouldn’t it be a good thing to be able to surf around this data base to see what had been reported? Or to be able to ask your doctor why she’s recommending this 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.