New Updates to FDA's Website Make it Easier to Track Device Recalls, Drug Changes

Regulatory NewsRegulatory News
| 20 August 2014 | By Alexander Gaffney, RAC

US regulators have announced the release of a treasure trove of data regarding medical device recalls and drug labeling, the latest releases under the US Food and Drug Administration's (FDA) new openFDA program.


The openFDA initiative was born from a May 2013 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 hoped, 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.

The openFDA website launched in June 2014, offering access to drug adverse event data through its open APIs. Already, one company, Social Health Insights, has launched a website specifically tailored to make 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."

New API Releases

But since the launch of openFDA, the agency, spearheaded by Kass-Hout, has been releasing ever more APIs for public use.

In July 2014, for example, openFDA launched a new API that allows the public to more easily track pharmaceutical and medical device recalls. Regulatory Focus has already dug into that data and found a dramatic increase in recalls over the last few years.

And this week, openFDA has released two new APIs: One for medical device adverse events, and another for FDA-approved drug labeling.

Device Adverse Events

FDA has long collected medical device adverse events through its Manufacturer and User Facility Device Experiences (MAUDE) system, which receives "several hundred thousand" reports each year, according to FDA.

"The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products," FDA explains on its website. "The MAUDE database houses MDRs submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers."

And while FDA is gradually working to phase out MAUDE in favor of a new vigilance software system known as PRIMO, nearly all of its data—going all the way back to 1991—is now available through openFDA.

In a statement, Kass-Hout said the API could potentially identify new safety signals or classes of devices which could be dangerous. He also cautioned that data contained in the reports was potentially incomplete, inaccurate or biased, and should be treated as a tool for generating—and not answering-hypotheses.

FDA's website currently contains more than 3.6 million adverse event reports for medical device-related incidents.

New Labeling Update

A second project announced this week has to do with drug labeling. While this data has long been available through FDA, it hasn't always been easy to get, Kass-Hout explained.

"For several years, the labeling has been posted publicly in Structured Product Labeling (SPL) format at," he wrote in a blog posting on FDA's website. "We’ve created an API for the data to supplement (not replace) these resources, and to provide easy and timely access to changes or updates to the labeling."

Kass-Hout said he envisioned the service being used to identify new boxed warnings on products, allow doctors to monitor specific subsets of products for labeling changes and to determine when certain drugs are contraindicated with certain products or substances (like grapefruit juice).



FDA Voice: Devices

FDA Voice: Labels


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