IVD Technology
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Originally published January, 1998
Editor's Page
Sense and Sensitivity
I admit it: politics baffle me. And just when I think I've made sense of it all, something comes along to confound me even more.
Take for example the FDA Modernization Act of 1997. Now there's a bill that makes sense. It combines many of the best ideas proposed by industry over the past half-decade with solid administrative reforms like those already under way at FDA. In the words of Alan Magazine, president of HIMA, the act "will better equip the agency to deliver life-saving, life-enhancing medical technologies to patients in a more efficient and expedient way while at the same time keep in place FDA's standards of ensuring medical devices are safe and effective."
This is obviously true, and there are a great many people who are to be congratulated for their hard work in bringing about such reforms. But I am puzzled by one provision of the act that ought to be of particular interest to diagnostics manufacturers.
Imbedded deep in the act's text is a short "sense of Congress" provision (section 215) entitled simply "noninvasive blood glucose meter." Coming in the midst of an agency reform bill, it is curiously positioned. And it is even more curious for what it says—and doesn't say. It first offers a series of congressional findings, including the fact that 16 million Americans are affected by diabetes, with annual health-care-related costs of nearly $100 billion. It also informs us that the pain associated with the use of existing blood glucose monitors "creates a disincentive for people with diabetes to test blood glucose levels," and that FDA "is responsible for reviewing all applications for new medical devices in the United States." These are hardly revelations.
Having prefaced its statement so strongly, however, Congress might have been expected to issue some new marching orders on the subject; for example, by authorizing government funding to support the research and development necessary to obtain an approvable noninvasive blood glucose monitor, or by directing FDA to find some safe way of making such a device available to the public. Instead, section 215 ends with a whimper: "It is the sense of Congress that the availability of a safe, effective, noninvasive blood glucose meter would greatly enhance the health and well-being of all people with diabetes across America and the world."
Even more mysterious is the intent of section 215. Nearly every other provision of the modernization act directs FDA to do something—or to stop doing something. But section 215 is a different animal—one without teeth. "It doesn't say we have to do anything," notes Joseph Hackett, associate director of the CDRH Division of Clinical Laboratory Devices.
Although passage of the modernization act demonstrates that Congress can be sensitive to issues that affect both industry and the public health, section 215 suggests that not quite everything may make sense. Without a clearer directive, what will industry and FDA make of it? So far, Hackett confirms, "No one at FDA is talking about section 215."
But if the next generation of glucose monitors is to get onto the market in a timely fashion, perhaps someone should be talking about it—and considering how to carry it out. We'll get the ball rolling with this issue of IVD Technology. Now, discuss.
Steven Halasey
