This week has seen another FDA meeting seeking guidance on how
to regulate direct-to-consumer (DTC) genetic tests in the US.
The meeting itself has been covered by GNZ bloggers Daniel at
Genetic Future and Dan at Genomics Law Report, and its apparent
outcome has sparked furious debate elsewhere. The discussion
among the “independent” panel convened at the meeting appeared
to converge on the proposal that all health-related genomic
tests should be ordered and reported through physicians.
However, the outcomes of the meeting in terms of FDA policy
remain unclear, and one FDA official has indicated that
decisions about the availability of genetic tests will be made
on a test-by-test basis. There is no doubt that the appropriate
regulation of personal genomics tests is a complex issue, and
there is a diversity of opinion about how best to achieve it
within GNZ (as there is throughout the genomics community).
However, there are several points we agree on: - Individuals
have a fundamental right to access informatio