FDA Launches Huge Online Database of Adverse Events

As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA collected between 2004 and 2013 available to the public in a more user friendly and easily searchable format. Previously, the public could access this information only through Freedom of Information Act (FOIA) requests or by combing through hard-to-use reports.

The FDA created the database under the recent Presidential Executive Order on Open Data and in alignment with the Department of Health and Human Services' Community Health Data Initiative.

After this initial pilot phase, the FDA plans to roll out more information, including data on product labeling and product recalls, in a similar format.

Goals of openFDA

The FDA hopes software developers and other technology specialists will build on this new data format to create mobile applications and interactive websites that allow users to more quickly and easily search the agency's adverse event information.

openFDA is designed to make it easier for web developers, researchers, and the public to access and use the large public health datasets the agency collects. Walter S. Harris, the FDA's chief operating officer and acting chief information officer, says openFDA will "spur innovation, advance academic research, educate the public, and protect public health."

What This Means Going Forward

Academic researchers, pharmaceutical companies, and the public at large, will likely benefit from easier access to this information. Pharmaceutical companies file hundreds of FOIA requests every year to acquire adverse event statistics. Having this data in a format that is easier to access, search, and analyze will save money and resources, and enable researchers and pharmaceutical developers to use this information in ways that benefit society as a whole. For example, researchers and developers will likely find this information valuable as personalized medicine becomes increasingly important and pharmaceutical companies seek to develop more targeted medications with greater levels of efficacy.

But, new accessibility to millions of adverse event reports could also contribute to a growing distrust of the pharmaceutical industry in some sectors of the public, as evidenced by the burgeoning anti-vaccine movement. As more parents refuse to vaccinate their children, public health professionals are increasingly concerned about the potential resurgence of measles, whooping cough, and other preventable and previously well controlled illnesses, illustrating the dangers posed by widespread misinformation about pharmaceutical products.

The adverse event database could pose similar misinformation risks because many people do not understand the legal framework behind adverse event reporting. They may not know, for example, that an adverse event by itself does not prove a causal link between the medication in question and the event, or that pharmaceutical companies report all known adverse events to the FDA, regardless of any indication that the medication caused or contributed to the reported event. Thus, like the anti-vaccine campaigners, uninformed or misinformed sectors of the public who use openFDA could mistakenly believe that certain medications pose unreasonable safety risks.

In addition, plaintiffs' attorneys will likely seek to use this more easily available adverse event information (and the forthcoming recall and labeling information) in litigation against pharmaceutical and medical device companies.

It will take concerted effort by the FDA, along with other public and private stakeholders, to educate the public to ensure that this new openness contributes more to public safety and innovation than to the dissemination of unscientific claims aimed at creating public panic or generating baseless litigation.

The FDA provides more information about openFDA at open.FDA.gov or by email at open@fda.hhs.gov.