Regulatory Focus™ > News Articles > FDA's Adverse Event and Postmarketing Surveillance Efforts get Major Data Boost

FDA's Adverse Event and Postmarketing Surveillance Efforts get Major Data Boost

Posted 12 February 2014 | By Alexander Gaffney, RAC

The US Food and Drug Administration's (FDA) efforts to keep track of adverse events and medical outcomes is about to become even more robust thanks to the inclusion of the US' largest healthcare provider into its databases.

That provider isn't a private insurer or company-it's the Department of Veterans Affairs' (VA) Veterans Health Administration (VHA), which serves nearly 9 million veterans each year at more than 1,700 facilities in the US.

As part of VHA's mission, it maintains several National Patient Databases (NPDs) containing data from its medical centers, its service networks and facilities, the Department of Defense and even the US Food and Drug Administration (FDA).

Now those databases are set to send, rather than just receive, information back to FDA.

In an 11 February 2014 announcement, the VA said it was amending the protocols that govern the use of its NPDs to allow it to disclose health care information to FDA.

Specifically, it will be allowed to share with FDA reports of adverse events, product defects or problems, and biological product deviations. In addition, it will share information on product tracking, enable products to be recalled or repaired and allow the agency to conduct postmarketing surveillance on products.

The revised system is set to become active on 13 March 2014 assuming no adverse public comments are received by the agency.


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