Five U.S. Senators have signed a letter urging the Office of Management and Budget (OMB) to released a draft guidance on LDT regulation. OMB apparently has 90 days to review regulatory policies but has held the FDA’s draft guidance on LDTs “for several years.”
While FDA has hinted in the past that it was developing or had developed a “risk based” approach to LDT regulation, this is the first confirmation for me that
such a guidance has already been drafted, and that it is in fact out of FDA’s hands (and apparently has been for a long time now).
The White House seems not to share FDA’s position on LDT regulation. It would be interesting to know if negotiation is going on between the White House and FDA for modifications to the draft guidance.
Fierce wrote a nice summary of the letter and its implications.
Read the letter to OMB.