Posted 30 October 2015
By Zachary Brennan
Nearly 90% of the postmarket surveillance studies the US Food and Drug Administration (FDA) ordered over the past seven years were categorized as inactive, though some of these studies were added to other ongoing studies, according to a new Government Accountability Office (GAO) report.
Rep. Rosa DeLauro (D-CT) requested the GAO look into the postmarket studies of devices ordered by FDA, and this latest report investigates the types of devices for which FDA has ordered a postapproval study or a postmarket surveillance study and the status of these studies.
Under the current regulations, FDA may order a postapproval study for a device at the time of marketing approval through the premarket approval (PMA) process or the humanitarian device exemption (HDE) process. Postapproval studies are ordered to obtain additional information not available before devices are marketed, such as a device’s performance over the course of long-term use.
But for postmarket surveillance studies, which FDA may require for a particular safety issue, investigations can be ordered not only for PMA and HDE devices, but also for devices cleared through the less stringent 510(k) process.
For this report, GAO analyzed data provided by FDA from its Center Tracking System for postapproval studies ordered from 1 January 2007 through 23 February 2015, as well as FDA’s data for postmarket surveillance studies ordered from 1 May 2008 through 24 February 2015.
GAO found that for postapproval studies, cardiovascular devices, such as stents and heart valves, accounted for 56 percent of the 313 studies ordered by FDA "and most were making adequate progress." Orthopedic and general and plastic surgery devices were the second and third most common subjects of postapproval studies.
In addition, most of the other postapproval studies FDA ordered (182 studies) were ongoing and making adequate progress, while 43 other studies were found to have inadequate progress or to otherwise be delayed. One key reason FDA officials pointed to for a study’s delay may be limited patient enrollment.
In terms of study design, 69 percent of the 313 postapproval studies ordered were prospective cohort studies—meaning one group using a particular device was compared to a second group not using that device.
Of the studies GAO reviewed, on average, manufacturers completed postapproval studies in about three years, with the longest study taking almost seven years.
Unlike postapproval studies, FDA may order postmarket surveillance studies when a device is approved or afterward, particularly if FDA becomes aware of a potential safety issue.
For instance, safety concerns about metal-on-metal hip implants, including potential bone and tissue damage from metal particles, led to an increase in postmarket surveillance studies ordered in 2011.
GAO found that 40% of the 392 postmarket surveillance studies, most of which came in 2012 following an increase in safety concerns, were for implanted surgical mesh and other devices used in general and plastic surgery and obstetrics and gynecology procedures.
However, 88% of the postmarket surveillance studies GAO analyzed were inactive as of February 2015.
Inactive studies include those that were consolidated (108 of 392 studies), meaning that a manufacturer was able to combine a postmarket surveillance study with another related study, and those that were inactive for other reasons, such as if a device is no longer marketed.
Another 12% of the postmarket surveillance studies were either still ongoing (40 studies) or completed (8 studies). Of the 40 ongoing, more than half were progressing adequately, according to FDA, and had been ongoing for an average of a little less than three years, though the rest were delayed and had been ongoing for an average of about four years.