IVD Technology Magazine | IVDT Article Index

Originally published March, 1997

Commentary

Ethics of IVD use are outside FDA jurisdiction

Glen Paul Freiberg

The September/October 1996 issue of IVD Technology offered two very different views on the issue of an individual's entitlement to obtain and make use of medical test results.

In her editor's page (p. 6), Jenevieve Blair Polin quotes the checklist question "Does the population at risk want the test?" as an influential factor in determining whether a test should be developed. Meanwhile, the commentary by FDA's Joseph L. Hackett, PhD (p. 24), states that "the intended use should offer some value to the user and the clinician." The major difference between these perspectives lies in their understanding of who the users of IVDs are.

Although the user to whom Dr. Hackett refers may sometimes be the patient, it is not clear that the patient's desire to know is commonly accepted as one of the legitimate clearance criteria at FDA's Division of Clinical Laboratory Devices (DCLD). Indeed, it would require a major policy shift for DCLD to recognize that patients might be entitled to have direct and unimpeded access to the results of their own medical tests. Still more remote is the possibility that DCLD might create a product clearance process that would allow laypersons to administer and interpret such tests on their own, without the intervention of health-care professionals or prior proof that the tests meet FDA's standards of effectiveness.

Nevertheless, FDA should give serious consideration to these issues. It should acknowledge the public's right to obtain medical information, and should not stand in the way of a test's availability and use, even when no medical interventions exist as therapy for a troubling result. Whether the user is a parent wanting the direct result of a child's drug screen, a potential HIV carrier wanting anonymous screening, or simply a layperson wanting knowledge about his or her genetic makeup, the user's desire to know should not be stymied by FDA's product-clearance processes. Ethics of IVD use are outside FDA jurisdiction.

A major step toward implementing such a change in attitudes would be replacing FDA's current requirements for safety and effectiveness data on IVD submissions with equivalent requirements for data about the safety and performance of such tests. As twin parts of the agency's product clearance process, demonstrations that a product is safe and performs properly should be sufficient for market approval. The absence of such demonstrations, on the other hand, should provide FDA with ample ammunition to prohibit the marketing of a test whose use or results might have a high potential for danger--whether within or outside the environments of medical or laboratory professionals. A product's utility or lack of utility alone does not constitute danger.

Moreover, the example of the European Union (EU) suggests that a standard of safety and performance would be more than adequate to meet the regulatory needs of the United States. In the EU, the IVD community is virtually unregulated at present, and yet there has been a distinct lack of reported problems.

There is little reason to believe that DCLD will voluntarily discard its current requirements for IVD effectiveness data. But if it does not, industry should support legislation to make this happen. Passage of such legislation would put an end to DCLD's efforts to bureaucratically regulate the practice of medicine, eliminate government judgment about the value of a test as a barrier to product clearance, and help to reduce delays in the clearance of tests to market.

Together, safety and performance data are enough. Government should be relieved of the task of making value judgments that affect product clearances. With the help of the medical and laboratory communities, individuals can judge the value of such tests for themselves. And in that open marketplace, safe products that perform properly but have no value will not survive.

Glen Paul Freiberg is vice president for regulatory, clinical, and quality systems at Bard Diagnostic Sciences, Inc. (Redmond, WA), and is a member of the IVD Technology editorial advisory board.