On November 22, 2013, the Inquisition collided with the Internet. On that date, the Food and Drug Administration issued a Warning Letter threatening 23andMe, Inc. with seizure of product, injunctions and civil monetary penalties based on allegations that 23andMe – which provides customers with information about their personal genomes – is selling misbranded and adulterated medical devices. In plain terms, FDA has sought to restrict dissemination of this information for no other reason than an undocumented fear people might misuse it. If FDA follows through on its threats of regulatory action, this dispute could provide the forum for defining the First Amendment limits of the FDA’s power to regulate public health by restricting dissemination of information.
By way of brief background, for $99, 23andMe provides a receptacle for a saliva sample and a mailer. Upon receipt, 23andMe extracts selected genetic information … Read More »
The FDA’s warning letter to 23andMe, the maker of mail-order genetic tests, highlights the challenging legal and ethical issues posed by such products. While the FDA’s letter focuses on charges that (a) 23andMe’s DNA collection kit is an adulterated Class III medical device because it has not obtained prior regulatory clearance, and (b) the product is misbranded because 23andMe has failed to provide adequate evidence that its product provides accurate results, the situation raises additional questions.
For example, should direct-to-consumer medical genetic testing (DTCMGT) be regulated as “the practice of medicine”? To date, DTCMGT, which takes place outside of the traditional medical setting, has not been subjected to state law regulatory requirements applicable to “the practice of medicine” imposed on medical providers. Such requirements could assure involvement of a genetics professional in the testing, which could reduce risks of inadequate informed … Read More »