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Are Device Manufacturers Playing Bait-And-Switch With The FDA?

The problem with the FDA is that it often requires so much proof of safety and effectiveness that the time it takes to bring a new product to market can grow by three, four, or even more years. FDA delays 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 post-approval studies (PAS) program. 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 PAS 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 the 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." In fact, almost half of post-market studies are funded without support from the manufacturer.

Why are manufacturers being so lax in conducting post-market research? For starters, such studies are expensive. More importantly, their laxity goes unpunished -- to date, according to the authors, "the FDA has not imposed penalties against manufacturers failing to comply with post-market study requirements." Post-market surveillance is critical because relatively rare treatment complications are not going to come to light in studies of 200 or 300 patients. Yet these complications can affect thousands of people once the product reaches a broader population.

If industry leaders want to avoid such delays with the FDA, then device companies need to follow through with solid post-market surveillance when their products receive expedited review.

Read the full article here.

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