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Michael Monheit
Michael Monheit
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A Busy Week for the FDA – Recalls and Regulations

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Monitoring of drugs and medical devices even after they are administered to patients is a crucial component of ensuring patient safety. And the FDA, the agency responsible for approving those drugs and devices, has a key role to play in that process. But a couple of recent news articles highlight how the agency may be falling short when it comes to post-approval drug and device safety.

An article in Reuter’s reports on a recent study conducted by research at Brigham and Women’s Hospital in Boston that examined the FDA’s effectiveness at communicating drug recalls to doctors and patients. What they uncovered was a serious deficiency in the communication channels. Considering just the Class I recalls, that is, recalls classified as most dangerous, the researchers found that 18 of these types of recalls, or 20%, made between 2004 and 2011 were never communicated through official FDA communication channels with doctors and patients. According to the study’s authors, this means that “Despite recent efforts by the FDA to address the drug recall burden, health care providers may be inadequately informed about clinically important recalls that threaten patient safety.”

Post-market monitoring also is an issue for medical devices, and one that some patient safety organizations are hoping is addressed by the government soon. The Hill reports in its “Healthwatch” blog that the Advancing Patient Safety Coalition "said Monday that Congress should force the Obama administration to issue new regulations on medical devices." Those regulations would address what is known as a “unique device identification” (UDI) system that would enable regulators to track devices and monitor safety risks. That system was called for in 2007 legislation, but regulations have yet to be passed, a failure that the Coalition says is a “threat to patient safety.”