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Look for Over the Counter but Under the Radar: Direct-to-Consumer Genetic Tests and FDA Regulation of Medical Devices in the Spring 2009 issue (Vol. 11, No. 3) of the Vanderbilt Journal of Entertainment and Technology Law. The Abstract for the Note follows:
Direct-to-consumer genetic tests are laboratory-developed tests that are marketed and sold directly to consumers. They typically do not require a prescription or any other involvement from a consumer’s health care provider. Consumers order these tests online and return a specimen, usually a saliva sample, directly to the laboratory. The results are mailed directly to the consumer, and no health care provider or insurance company need ever learn the contents of these results. The FDA does not currently regulate direct-to-consumer genetic tests, though tests for hundreds of different diseases are readily available to the public.
The FDA’s approach to regulating genetic tests is not uniform. The FDA regulates “test kits,” or genetic tests developed by a manufacturer independent from the clinical laboratory that distributes it, as medical devices. These test kits are not available directly to consumers; instead, the laboratories send them to health care providers for patient diagnosis.
Absence of FDA regulation of direct-to-consumer genetic tests means that consumers utilize these tests without any assurance of their reliability, accuracy, or usefulness in helping individuals make prudent health care decisions. Furthermore, individuals often receive their test results directly from the laboratory without any formal genetic counseling regarding the meaning of these results, which are often less straightforward than consumers may expect.
This Note differentiates between test kits and home brews, indentifying the hazards that direct-to-consumer genetic tests pose to the public due to the fact that they are unregulated. It also analyzes the FDA regulatory process that medical devices undergo in order to be marketed and sold. Finally, the Note advocates for FDA regulation of direct-to-consumer genetic tests as medical devices, just as test kits are, based on the protections that this regulatory process affords consumers.
– Note Author: Lauren B. Solberg
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