Robinson Bradshaw

Topic: GPPC

Updating the DTC Debate: Trial by Press Release, More FDA Letters, the Problem of Pleiotropy and New RUO Guidance

Later today I will join several colleagues here in Chicago, IL at the American Society of Clinical Oncology (ASCO) annual meeting for a panel discussion on Direct-to-Consumer Genetic Testing for Cancer: What Physicians Need to Know (pdf). (Daniel MacArthur and Misha Angrist will not be on the panel, although each joined us in authoring the […]

Surreptitious Genetic Testing: WikiLeaks Highlights Gap in Genetic Privacy Law

The top news story the past two weeks: the release of hundreds of thousands of confidential American diplomatic cables by WikiLeaks. While dissecting diplomatic maneuvering is not a traditional area of expertise for the Genomics Law Report, a pair of cables did catch our eye. The first is primarily a curiosity: the allegation that Chinese […]

While You Were Meeting: FDA Mails Letters to 14 More Genetic Test Providers

Earlier this week the FDA held a widely publicized two-day public meeting to discuss its planned regulation of laboratory developed tests (LDTs) (for more see: Day One Recap and Day Two Recap). Other than Monday morning, when the FDA presented background information on LDTs and some of the considerations that have pushed the Agency to […]

The Wild, Wild East of DTC Genomics and the Need for Meaningful Self-Regulation

Earlier this month CNN reported on the launch of a new program by the Chongqing Children’s Palace (CCP), in Chongqing, China, “that uses DNA testing to identify genetic gifts and predict the future.” In a story seemingly more appropriate for the Onion than for CNN, the article reports that Chinese scientists at the CCP are […]

Regulating Advertising Practices of DTC Genetic Testing Companies?

The Genetics & Public Policy Center (GPPC) has commissioned a 50 state survey of “laws that could potentially be used to protect consumers against unfair or deceptive trade practices by DTC genetic testing companies.”  You can see the full survey here (pdf) or you can jump directly to the conclusion: “The survey reveals that while all […]