Bioethics Blogs

Are Device Manufacturers Playing Bait-And-Switch with the FDA?

The problem with the FDA is that if often requires so much proof of safety and effectiveness that the time it takes to bring a new product to market can grow by 3, 4, or even more years. FDA delays into the time that companies have to exclusively produce and sell their products.

In recognition of this problem, the FDA sometimes grants marketing approval to innovative new devices through a Pre-Market Approval Pathway, or PMA. Under this pathway, companies are allowed to bring their products to market more quickly – with less than optimal evidence on safety and effectiveness – as long as they promise to continue collecting such data through post-market surveillance.

According to a study in JAMA, device manufacturers often fail to keep up their side of this bargain.

In the study, Vinay Rathi and colleagues looked at all 28 new high risk devices receiving PMA approval in 2010 and 2011. They found that FDA approval was often based on scant data – studies of less than 300 patients with no blinding and limited follow-up. (With blinding, clinicians measuring patient outcomes do so unaware of which patients have received which interventions. Without blinding, such outcome measures can be biased by clinicians’ expectations.)

Given the small number of patients studied prior to market approval, it is that much more important that manufacturers continue to collect data once their products come to market. Unfortunately, most devices are not well studied once on the market. According to authors of the JAMA study: “Most devices have been or will be evaluated through only a few studies, which often focus on surrogate markers of disease in small numbers of patients followed up over short periods of time.”

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.