It came to my attention yesterday that Genentech has submitted a Citizen's Petition requesting that FDA apply equal scentific and regulatory standards to in vitro diagnostic (IVD) tests that are used to determine treatment options* regardless of how they are sold. This would level the playing field for all diagnostics, including Laboratory Developed Tests (LDTs).
If Genentech has their way, all IVDs will require FDA review. This would eliminate the "CLIA-only" path to market that currently exists for many LDTs. This approach has much more far reaching implications than FDA's IVDMIA guidance document.
Genentech's logic is sound. There is no public safety reason why the distribution method of diagnostic products should change their regulatory requirements. The reasons why this occured are a combination of conflicting regulatory mandates (CLIA vs. FDA) and historically low profit margins for many diagnostics. For some tests, the reimbursement is low enough that adding the cost of compliance with FDA regulations could simply make the tests not viable.
It's also important to remember that FDA has made the playing field unlevel of other types of products. For example, some drugs qualify for 505(b)(2) status. This exemption allows the manufacturer to rely heavily on published data. There are also lighter regulations for well-characterized drugs that are off patent -- generics.
I agree with Genentech that something needs to be done to make the playing field more equal. However, we need to consider a variety of alternatives including allowing a 'generic' type of approach when a test has been in use for a long time and when it is well-understood how to create the assay in the lab. We should also include some sort of humanitarian use for products that are less well understood but could have a major impact on the health of Americans.
* This blog corrected 1/15/09