Transparency First: A Proposal for DTC Genetic Testing Regulation

These are hectic days for the field of direct-to-consumer (DTC) genetic testing. Every week, and sometimes every day, seems to bring a new development. Two weeks ago it was pharmacy giants Walgreens and CVS unveiling agreements with Pathway Genomics to offer Pathway’s genetic testing kits in drugstores nationwide, to which the FDA responded first by declaring such a strategy illegal and, shortly thereafter, launching an investigation. Last week, on the same day that the University of California, Berkeley announced it would be offering genetic tests to all incoming freshmen, a House of Representatives committee announced it was launching its own investigation into three prominent DTC genetic testing companies.

These developments reflect an uncertainty about the regulatory status of DTC genetic testing that is dramatic, although it is not new. In the summer of 2008, public health officials in New York and California sent warning letters to a number of DTC companies, including 23andMe and Navigenics (both targets of the current Congressional investigation). These state regulatory activities prompted concern that other states might follow suit, potentially subjecting DTC companies to the nightmare scenario of inconsistent state-by-state regulation. Nearly two years later, those particular concerns appear to be unfounded.

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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomic Policymaking, Genomics & Society, Legal & Regulatory, Pending Regulation

Does Familiarity Breed Acceptance? New Program Encourages Young Doctors to Get Personal with DTC Genomics.

DoctorThe Genomics Law Report launched its new series What ELSI is New? yesterday with guest commentaries from Hank Greely and Misha Angrist. One of the issues that both Greely and Angrist tackle—from different angles and with decidedly different styles—is the widely acknowledged shortage of health care professionals qualified to understand and interpret genomic information of increasing prevalence and complexity.

By sheer coincidence, yesterday’s Boston Globe profiled a new program at Beth Israel Deaconess Medical Center that invites pathology residents to learn about DTC genetic testing in a novel way: by becoming customers themselves.
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Filed under Direct-to-Consumer Services, Genetic Testing/Screening, Genomics & Medicine, Legal & Regulatory