Law Commons^™

Over The Counter But Under The Radar: Direct-To-Consumer Genetics Tests And Fda Regulation Of Medical Devices, Lauren B. Solberg

Vanderbilt Journal of Entertainment & Technology Law

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 …

Giving The Terminally Ill Their Due (Process): A Case For Expanded Access To Experimental Drugs Through The Political Process, Linda K. Leibfarth

Vanderbilt Law Review

The stated purpose of the Food and Drug Administration ("FDA" or "Agency") is "to promote and protect the public health." In furtherance of this end, the FDA has created a regulatory framework to ensure that drugs marketed to the general public are both safe and effective. However, critics insist that the FDA's paternalistic drug approval process does little to achieve its goal. At the onset of the AIDS epidemic in the 1980s, criticism of the FDA intensified, as the FDA's lengthy and expensive drug approval process hindered terminally ill AIDS patients' access to potentially lifesaving treatment. Advocates for these patients …