Rollout of openFDA continues with drug labeling, medtech adverse event APIs

Having committed to a fast rollout of application programming interfaces (APIs) at the start of the summer, the FDA made good on its promise this week by making data on drug labeling available. And the regulator went beyond its initial commitment by releasing an API for medical device adverse events.

FDA chief health informatics officer Dr. Taha Kass-Hout--Courtesy of the FDA

The release of the drug labeling APIs means the FDA has now shared the three data sets it committed to earlier this year. The FDA got the project started in June with the release of an API for drug adverse events and followed that up with the publication of a source of recall data in July. The drug labeling API is the third and final piece of the FDA's initial rollout strategy. While the data was already available in structured product labeling (SPL) format, the FDA sees benefits to using an API.

Software can interact directly with the API, potentially enabling developers to create apps and websites that make the data more useful to people. The expectation is that these resources will complement SPL-formatted data. "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," FDA chief health informatics officer Dr. Taha Kass-Hout wrote in a blog post.

Throughout the summer Kass-Hout has talked about the FDA's plans to continue adding APIs once the first wave of resources for labeling, drug adverse events and recalls was completed. This process began the day after the publication of the labeling API when the FDA released a new way for developers to access medical device adverse event data. The medical device API covers adverse event reports dating back to the early 1990s.

- read the labeling blog
- here's the medtech news
- and Regulatory Focus' take