Does FDA Have a Postmarket Surveillance Problem?

A new Yale University-led study finds few studies three to five years after FDA approval of risky medical devices.

Nancy Crotti

Major media outlets, including Reuters and the New York Times, have recently published stories pointing out the fact that FDA approves many high-risk medical devices after only one study to prove their safety and efficacy.

This, however, is old news. Previous studies have reported the same thing, according to Yale University's Joseph Ross, MD, principal researcher of a recent study of FDA approvals and principal writer of the report on it that appeared in the Journal of the American Medical Association.

Ross said his research team was more surprised by how little follow-up FDA does on high-risk devices it has already approved. (For an argument on the other side of the debate, check out a recent Harvard Business School study that claims FDA bureaucracy is unnecessarily stifling innovation.) 

The Ross-led team from Yale University, the University of Colorado, and the Colorado Cardiovascular Outcomes Research Consortium isn't blaming FDA, however. The agency is only following the law, Ross said. That law could change to require even less official regulation if the U.S. Senate passes the version of the controversial 21st Century Cures Act approved by the house in July.

The bill was designed to speed the time to market for medical devices and drugs, while raising $8.75 billion over five years in funding for medical research.

What the research team didn't expect, given FDA's emphasis on lifecycle evaluation of medical devices, was "so few studies to be initiated and to be finished three, four, five years after approval," Ross said. The Medical Device Innovation Consortium (MDIC), a public-private partnership devoted to the advancement of regulatory science in the medical device industry, aims to coordinate the development of methods, tools, and resources used in managing the lifecycle of a medical device.

The 2010-2011 study says that FDA approved 26 of the 28 high-risk devices during the study period "on the basis of a single pivotal premarket study." Ten of the approved devices were recalled at least once, with one subject to a Class I recall and one voluntarily withdrawn from the market, the study says. More than 46% of the devices had three or fewer postmarket studies.

FDA can require post-approval studies, but those may be "small, delayed or not generalizable," the study says. Plus, only one-quarter of post-approval studies conducted between 2005 and 2011 were completed, it adds.

Ross believes FDA is hamstrung by a law that requires the "least burdensome" postmarket data necessary to address unresolved clinical questions about devices. The agency has not imposed penalties on manufacturers who have failed to conduct mandated postmarket studies.

"We have to think about other ways for the system to enhance the information that's available to clinicians and patients," perhaps culling that information from electronic medical records, Ross said. "I'm glad that our article is out before any laws pass so people can make a data-based decision."

Nancy Crotti is a contributor to Qmed and MPMN.

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