Fascinating and informative BioCenutury cover story on a 21t century regulatory pathway for diagnostics. Penned by the always informed Steve Usdin, here are some snippets:
FDA and members of Congress are putting the finishing touches on different proposals to create a new regulatory pathway for diagnostics, making it almost certain that major changes will be unveiled in 2011. The question is which approach will prevail — and whether either approach solves the problem of value-based reimbursement.
Top FDA officials and lawmakers have concluded that the current oversight system for diagnostics, which imposes premarket review requirements for in vitro diagnostics (IVDs) but not for the vast majority of laboratory-developed tests (LDTs), is not sufficient to protect the public or to support the development of innovative tests that are at the heart of hopes for widespread adoption of personalized medicine.
The only option that is off the table is the status quo.
Senator Orrin Hatch (R-UT) is lining up bipartisan support — and his staff is trying to build consensus among labs, diagnostics companies and investors — on draft legislation that would preempt FDA’s efforts. His approach would create a new regulatory category encompassing both LDTs and IVD tests.
Under the Hatch bill, IVDs would no longer be regulated as medical devices. Also, FDA would for the first time routinely regulate tests performed in labs, although lab services and operations would continue to be regulated by the Centers for Medicaid and Medicare Services (CMS) under the Clinical Laboratory Amendments (CLIA) (see “BETTER at a Glance”).
Hatch hopes to use a new regulatory system to go even farther, as a platform for launching reform of diagnostics reimbursement policies, and shifting Medicare from a payment system based on the complexity of test procedures to one based on the value of tests, according to diagnostics.
FDA has clearly signaled that in the absence of legislation, it intends to regulate LDTs, fitting them into a structure that many labs and IVD manufacturers argue is ill-suited for diagnostics.
Indeed, according to Alberto Gutierrez, director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OVID), laboratory directors who hope FDA will back off from its plans to regulate their tests are like “ostriches which have their heads in the sand.” Gutierrez, who made the comment at a Nov. 22 meeting organized by ACLA, said the agency is writing a guidance document outlining a proposed diagnostics oversight framework. While he declined to say when the guidance will be released, FDA has already begun recruiting staff to implement it. At the same time, FDA has indicated that it will move slowly, leaving room for Congress to intervene before the agency implements any major changes.
“The success of personalized medicine depends on having accurate diagnostic tests that identify patients who can benefit from targeted therapies.”
(From July NEJM commentary jointly authored by FDA Commissioner Peggy Hamburg and NIH Director Francis Collins.)
The complete BioCentury article can be found here.
Diagnostical Materialism
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