FDA Urged by the Washington Legal Foundation to Stop calling Devices Drugs
POSTED ON 9/27/2011 IN Industry News BY Christopher Centeno
The FDA has had the tendency of late to call everything drugs. It started with the FDA calling the cells in our bodies prescription drugs. It then devolved to Cheerios and Walnuts are drugs. Now the FDA is claiming certain medical devices are drugs. On this last point, the Washington Legal Foundation issued a press release yesterday in which in layman's terms it says, FDA stop calling devices drugs: FDA URGED TO WITHDRAW DRAFT GUIDANCE REGARDING DRUG/DEVICE CLASSIFICATION The Washington Legal Foundation (WLF) yesterday urged the Food and Drug Administration (FDA) to withdraw a Draft Guidance it issued in June regarding the classification of medical products as either drugs or medical devices. In formal comments filed with FDA, WLF argued that the Draft Guidance conflicts with the federal statute that defines what constitutes a “medical device.” WLF noted that the new policy would cause numerous products that were previously classified as medical devices to be reclassified as drugs. WLF also argued that the Draft Guidance violates the Administrative Procedure Act (APA), because all major changes in FDA policy may only be undertaken pursuant to the APA's formal notice-and-comment rulemaking procedures, not pursuant to informal guidance documents. “As the size of the administrative state grows, it is important that citizens continue to have a meaningful opportunity to participate in the operation of their government,” said WLF Chief Counsel Richard Samp after filing WLF's comments. “The APA is an important part of that effort. It ensures that agencies will be bound not only by congressional laws but also by their own internal rules. FDA needs to cease its practice of ignoring APA requirements” Samp said. Read more...
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