Former FDA Deputy Commissioner Says Postmarketing Surveillance is Badly Needed

There is a pressing need in the device sector for postmarketing surveillance, but though the FDA is considering using medical records to track device safety, any such system is years from adoption, would need additional funding, and may not survive the new administration’s interest in deregulation.

That’s according to Joshua Sharfstein — who served as FDA deputy commissioner from 2009 to 2011, was then secretary of the Maryland state Department of Health and Mental Hygiene, and is now associate dean at the Johns Hopkins Bloomberg School of Public Health.

To illustrate the point, Sharfstein and researchers Rita Redberg and Alison Jacoby use power morcellators as an example, in a Journal of the American Medical Association article.

Even though the risk of potentially spreading cancer was known at the time of FDA clearance of the first of these devices in 1991, no clinical studies to assess the issue were required and no postmarketing requirements for data collection were put into place, wrote Sharfstein et al.