More than 100 signatories recently sent a letter (PDF) to incoming HHS Secretary Kathleen Sebelius outlining broad priorities for IVDMIA and the future regulation of Personalized Medicine. The letter was signed by policy groups, IVD manufacturers, VC firms, foundations and patient advocacy groups.
The letter calls for "a new regulatory framework" where "new regulatory oversight policies be clearly stated and publicly vetted before they are implemented" and oversight of all advanced IVDs and LDTs "should be risk-based" and allow for "collaboration with extramural experts to augment HHS's capabilities as needed."
On first read, that seems pretty reasonable. But what are they actually asking for by urging a "risk-based" regulatory framework for IVDs and LDTs? Doesn't FDA already make regulatory decisions based on risks?
The thing that is special about IVDMIA is that it applies to tests based on their complexity and opacity rather than according to the degree of risk associated with the diagnosed condition. So IVDMIA applies to complex LDTs that predict halitosis or baldness, not just those that influence cancer therapy. It seems a bit silly to apply one standard to both types of tests.
If that were all there were to it, I'd be signing that letter too. But that's not what all this is really about.
As it stands, LDTs are subject to far lower levels of regulatory scrutiny. This lower standard is achieved not based on risk, but on arbitrary distinctions related to technology choices and business practices. IVDMIA is, first and foremost, an effort to address a very large gap in the regulation of diagnostic tests. It is appropriate that the remedy (broad regulation based on type of test) matches the problem (broad non-regulation based on type of test).
That said, of course FDA should prioritize oversight of tests that have higher risk profiles. That's a no-brainer. FDA should also ensure that passage of IVDMIA doesn't preclude the existing paradigm of classifying devices based on risk. That's a no-brainer too. People who fear that IVDMIA will create a new all-PMA system should look to the fact that FDA has already issued some 510(k)s under IVDMIA.
The real agenda of this letter, I fear, is to delay enforcement of IVDMIA by raising a non-issue and urging us all to revisit the public discussion that has already taken up years. That's understandable, given how much money many of the signatories have at stake. But further delay does not serve the public health interest nor, frankly, does it truly serve the cause of promoting innovation in medicine. When one category of diagnostic tests are held to almost no clinical standards, it holds back the entire industry.
We all want regulation and enforcement that strikes the right balance. When IVDMIA is enacted, I think we'll be one step closer to having it.