Agency crack downs on genetic tests
In May, FDA objected to San Diego-based Pathway Genomics' attempt to market an OTC genetic test collection kit at Walgreens drug stores because it is outside the boundaries of the regulatory safe harbor for laboratory-developed tests, which are regulated by Centers for Medicare & Medicaid Services. Simply put: “The FDA does not consider distribution of a collection kit that is sold directly to the consumer to be within the boundaries of what is allowed for laboratory developed tests,” an agency spokesman said.Since then, both Walgreens and Pathway Genomics and some other companies have bailed out of such marketing programs, pending FDA's acquiescence.
Regarding the agency's concern about recent claims, Gutierrez said: “Well, the claims [made by the companies] have changed constantly. The original claims from three years ago were very, very vague.”