AdvaMed is continuing to draw attention to essential differences between medical device and drug postmarket regulation as FDA faces increased public scrutiny related to drug recalls.

In a Dec. 22 member newsletter, AdvaMed responds to a recent Journal of the American Medical Association editorial by Executive Deputy Editor Phil Fontanarosa, MD, et al. The Dec. 1 editorial calls for a major restructuring of FDA's oversight of postmarket surveillance (PMS) of drugs and devices.

The editorial argues that the federal government should consider creating "an independent drug safety board or independent agency for drug safety, specifically to oversee postmarketing surveillance for drugs and devices." Outgoing HHS Secretary Tommy Thompson said he may include a proposal for a new drug safety agency in a forthcoming report on drug safety. Senate Finance Committee leadership backed such a reform during a recent hearing on Merck's Vioxx , recalled because of adverse cardiovascular events.

In making its case that FDA is ill-equipped to oversee PMS, the editorial cites several recent pharmaceutical-related incidents, including the Vioxx recall. However, the authors offer no corresponding device-related examples to justify their contention that their proposed reforms to the drug postmarket surveillance system should also apply to devices, AdvaMed observes.

By including device PMS in its proposed reforms, the editorial "perpetuates the all-too-common misconception that there is no difference between drugs and devices," the trade association states.

"Taking such a 'one-size-fits-all' approach to PMS demonstrates a fundamental lack of understanding of the differences between devices and drugs," AdvaMed asserts, echoing a criticism the group leveled at FDA's March white paper on the stagnation of medical product R&D (¹ Also see "On FDA Critical Path, Device Industry Demands Independence From Pharma" - Medtech Insight, 16 August, 2004., p. 8).

"The lack of device-specific examples in the JAMA article is not a coincidence," AdvaMed observes. The group explains that nearly all device recalls are firm-initiated, and that the flaws usually can be resolved with relatively simple design or manufacturing tweaks. Drug problems, by contrast, often are related to the compound itself, and cannot be fixed without chemical alterations.

AdvaMed Distances Devices From Proposed Postmarket Surveillance Reforms

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