FDA Wants to Make Product Recalls Easier to Track

A little more than a month after first launching its long-anticipated openFDA project, the US Food and Drug Administration (FDA) has announced that it hopes the project can do for product recalls what it has already done for adverse event data.

Background

The openFDA initiative was born from a May 2012 order from the White House instructing federal agencies to begin implementing a new "digital strategy" aimed at making governmental information more readily available and accessible to the public.

At the core of the White House's strategy was a focus on application programming interfaces, better known in the technology industry as APIs, which allow various pieces of software to communicate with one another using standardized data formats.

Open APIs would, the White House hopes, allow people to access the raw data FDA puts out through its various databases—approvals,  adverse event reports, recall notices, etc—and repurpose them, potentially making them easier to use or more enjoyable to read.

openFDA Launch

In June 2014, FDA announced that it had launched a "beta" version of the openFDA initiative, offering access to drug adverse event data in the hopes that outside entities could build platforms to harness the data and put it into easy-to-understand formats.

Already, one company, Social Health Insights, has launched a website specifically tailored to making use and sense of FDA's data.

At the time, FDA Chief Health Informatics Officer (CHIO) Taha Kass-Hout said that in addition to easier access to data, there will be another obvious benefit for regulatory professionals: fewer Freedom-of-Information Act (FOIA) requests.

"In the past, these vast datasets could be difficult for industry to access and to use. Pharmaceutical companies, for example, send hundreds of FOIA requests to FDA every year because that has been one of the ways they could get this data," Kass-Hout wrote. "Other methods called for downloading large amounts of files encoded in a variety of formats or not fully documented, or using a website to point-and-click and browse through a database – all slow and labor-intensive processes."

The new system will allow for this data to be obtained far more easily, Kass-Hout said in a statement.

New Capabilities

Now the openFDA website is set to grant even wider access to FDA's data, Kass-Hout said.

Writing in a 16 July 2014 posting on FDA's Voice blog, Kass-Hout said the agency's Recall Enterprise System (RES)—the system which tracks all of FDA's recall data—is now being opened up to the public through a new API on openFDA.

"The recalls in this dataset provide an illuminating window into both the safety of individual products and the safety of the marketplace at large," Kass-Hout wrote. "The hope is that this API will be useful to developers and researchers interested in FDA enforcement actions. Developers can now call into the API to add recalls data to mobile apps or consumer websites. And researchers could use the API to study individual manufacturers, product categories, or specific foods or drugs."

While FDA already releases this information to the press using its weekly enforcement reports, those reports are often difficult to understand, and relevant information can be even harder to find.

The hope is that new sites will develop to not only make that information easier to parse, but also offer tailored reports relevant to specific audience. For example, an oncologist might only care about the recall of certain types of drugs, but have no interest in others. Websites which take in FDA's openFDA information and marry it to other data, such as drug classification data, might prove especially useful in this regard.

Kass-Hout also indicated that more data releases will be forthcoming "in the weeks ahead.” Already, ResearchAE.com, a website working closely with FDA, has a "coming soon" section for information on product labels.

openFDA's APIs are still not ready for clinical use, Kass-Hout cautioned.

- See more at: http://www.raps.org/regulatory-focus/news/2014/07/19729/FDA-Wants-to-Make-Recalls-Easier-to-Track/#sthash.rD8KHub4.dpuf