Janet Woodcock, MD, Deputy Commissioner, Chief Medical Officer, FDA, responded to the discussion about the FDA’s role in genetic testing.

She began by outlining the historical trajectory of the regulations, and then addressed various points of the conversation in turn. In the 1990s, the FDA undertook ASR regulation and thus created a scheme that ensured the proper production of reagents. CLIA was established as a quality system for labs, but currently CLIA is not capable of determining clinical utility.

The industry grew rapidly and LDTs became successful and widespread. Industry continued to advance and develop new technologies, and the definition of ASR was no longer clear. Because of misinterpretations, the FDA issued an ASR guidance. The FDA has also issued an IVDMIA guidance.

The newest types of tests, like pharmacogenomics, determine dosage and treatment. There is more at stake with tests that do more than diagnose. Clinical interpretation is more difficult with IVDMIAs; the average clinician is unable to interpret them.

The current scheme of enforcement discretion is not a good paradigm.

The FDA’s current position is that LDTs are considered medical devices, but the FDA has not proposed regulation for most LDTs. Ultimately, the courts will decide this issue.

Woodcock expressed disappointment that investors perceive the FDA as an entity that makes unpredictable changes. She said that open discussions with industry are valuable, and noted that all stakeholders (including government employees) become frustrated with excessive bureaucracy.

The FDA issues guidance documents because regulations take a protracted amount of time. Statutory changes are issued “once in a lifetime.”

Woodcock is not convinced that adverse event recording is valuable. Are the consequences of a given test really known? An outcomes assessment would be needed, but this is a costly solution.

She concluded by asserting that the data obtainable from the new generation of genetic tests is important information and admitted that federal agencies are struggling through the process of replacing old schemes. But she was ultimately optimistic: the future is bright for the public.