Diagnostics industry companies, patient groups, [BB1]and trade associations are speaking up in the wake of last week’s news that US Food and Drug Administration user fee reauthorization legislation – which Congress must pass soon to maintain agency operations – might not include long-discussed diagnostic regulatory reforms.
The VALID (Verifying Accurate Leading-edge IVCT Development) Act, which would allow the FDA to regulate in vitro diagnostics, including lab-developed tests (LDTs), had been bundled into the Senate’s user fee package and was widely expected to pass. However, some lawmakers are getting cold feet about drug pricing provisions within the Senate’s version of the bill and have pressed to strip the bill back to basics