A Risky Shortcut

Proposal to Permit the FDA to Rely on Journal Articles to Approve High-Risk Medical Devices Is Misguided

February 9, 2016 — A little-discussed proposal to authorize the Food and Drug Administration to rely solely on data published in peer-reviewed journals to approve the highest-risk medical devices (such as heart valves and some pacemakers) is misguided and would potentially put the public at risk, a Public Citizen report issued today concludes. Public Citizen’s new report, “A Risky Shortcut,” shows that retractions of peer-reviewed journal articles for errors and fraud have risen markedly in recent decades. The report documents specific peer-reviewed journal articles on medical devices that have inaccurately reported on the results of studies or have relied on studies that included biased designs.