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

ucm354989The FDA quietly unveiled plans to make adverse event reports more widely available through a project called openFDA. Instead of simply publishing unwieldy quarterly files, openFDA will let software makers tap directly into the data to build user-friendly and easily searchable programs for doctors and consumers.

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.

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 and physicians trying to use the FDA’s database on their own are in the wilderness. Since each file from the FDA covers three months, creating a complete record of problems associated with a particular drug over a period of years means deciphering and piecing together dozens of monster files. Currently, 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.

Once the information is easier to use, software developers will step in to meet the public’s demand for drug information. Mobile apps will let consumers compare over-the-counter drugs while they shop in the pharmacy, and software to immediately alert pharmacists when a company issues a recall. DrugCite currently uses the FDA’s archives to let users search for side effects by medication.

This should also shed some light on vaccine studies. I have already read a lot of web chatter that a definitive link has been uncovered. We should hear more about this in the future if true.

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