US FDA’s Cancer Drug/Diagnostic Pilot Program Aims To Close The Gap Between Regulation And Clinical Practice
Laboratory-developed tests may be misidentifying patients for treatment with targeted therapies. Under a new initiative, the FDA will work with sponsors to develop minimum performance characteristics for LDTs that may be used with an approved cancer drug in clinical practice.
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Without sponsors willing to work with them and in the absence of legislation giving FDA authority over lab-developed tests, the agency has launched internal programs to both gain more oversight – and spur innovation.
FDA launches what it hopes will the final push to reform the regulatory oversight system for lab-developed tests by proposing a relatively rapid transition period to require essentially all LDTs to comply with the existing regulations for in vitro diagnostics. Legislation, litigation, and industry negotiation will likely shape the final product.
A national stockpile could provide immediate relief in the case of shortages, but also a ‘floor’ under pricing that might prevent more shortages in the first place, the head of the US FDA’s Oncology Center of Excellence says.