Report: FDA Should Move Slowly to Regulate Genomic Medicine

The FDA will need to change its approach if it wants to regulate genomic medicine while encouraging the field to grow, a special report in the New England Journal of Medicine concludes.

The authors, from the University of Houston Law Center and the University of Washington’s bioethics and humanities departments, argue that rushing to regulate the growing field “could subject genomic testing to counterproductive regulatory burdens that may – ironically – diminish consumer safety and chill innovation.”

A more limited approach to regulatory reforms, however, could bring the FDA’s genomic oversight up to snuff, the authors say.

For example, they suggest the FDA work with the National Institutes of Health and private industry to create and fund a genomic database that sponsors could use in validating their diagnostics. Not enough genomic information is publicly available to discern the full effects of unusual genetic variants, they say.

Some resources used to develop the FDA’s Sentinel system for postmarket monitoring could also be diverted to a genomic database.

View the report at www.nejm.org/doi/full/10.1056/NEJMsr1501194. — Elizabeth Orr