FDAand key members of Congress have decided the agency's current policies aren't sufficient to ensure the safety and efficacy of pharmacogenomic diagnostics, so they have launched separate efforts to expand FDA's oversight of the field.
The legislative and administrative efforts are in their early stages, which may allow test developers, clinical laboratories, drug companies pursuing products coupled with companion diagnostics, and the medical community to shape the future regulatory environment.
Stakeholders will have a chance to express their views at a public meeting FDA is hosting on July 19-20 on the oversight of laboratory-developed tests (LDTs). FDA is soliciting proposals about how it should extend its reach to actively regulate LDTs - a domain it has up to now left largely untouched.
FDA historically regulated in vitro diagnostics (IVDs) based on where the tests are developed and performed. IVDs distributed as kits are regulated as medical devices and manufacturers must demonstrate clinical safety and efficacy prior to marketing