USA – FDA criticized for approval of genetic test for opioid addiction risk

Physicians and public health advocates are urging the US Food and Drug Administration (FDA) to revoke its approval of AvertD to predict the potential for opioid addiction and said the decision was based on methods that have been “abandoned” by mainstream genetics and could worsen the opioid crisis.

The request was made in a 4 April letter to FDA Commissioner Robert Califf and signed by 31 public health stakeholders, researchers, and physicians.

FDA approved AutoGenomics’ AvertD in December 2023 as the first test to evaluate individual risk for developing opioid use disorder based on a DNA sample, despite an 11-2 vote against the test by the agency’s General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee in October 2022. (RELATED: This Week at FDA: year-end guidance drop, counterfeit Ozempic, and moreRegulatory Focus 22 December 2023). AutoGenomics is a unit of SOLVD Health…