The FDA Opens Its Vast Files on Drug Side Effects to the Public

Thousands of times each day, the U.S. Food and Drug Administration receives reports about unwanted side effects of the prescription and over-the-counter medications it oversees. They stream in from patients and doctors—and from drugmakers, which are required to relay accounts of problems. This data, cataloging reactions as mild as rashes and headaches and as serious as internal bleeding and death, help the agency monitor drug safety. With millions of records created since the system began in 1998, it’s the world’s most extensive record of how drugs interact with the human body.

It’s also almost impossible for anyone outside the agency to use. The FDA publishes quarterly bulk files—the most recent one covers to the end of 2012—but they’re a blizzard of cryptic information that can only be deciphered with expertise and complicated software. Patients or doctors who want to see a report on a specific drug have to file a Freedom of Information Act request with the government. “If you’re someone who’s trying to make an informed decision about which drug should I take … it’s not well-formulated that way,” says Dr. Taha Kass-Hout, the FDA’s chief health informatics officer.