Bradley Merrill Thompson Quoted in "Overcoming Regulatory Challenges in Companion Diagnostics."

Thompson said: It's opaque and ad hoc. This is an important time for companion diagnostics. Developers are desperately looking for guidance on the regulatory framework for companion diagnostic approval and an opportunity to participate in fine-tuning that framework so it reflects the reality of test development. Manufacturers often struggle with a lack of clarity and consistency in FDA standards, and recent success stories are more about succeeding in spite of the current environment rather than success of a regulatory framework. For a few years, FDA has been working on a draft guidance document to provide clarity to those co-developing novel companion diagnostics with therapeutics, and when published, it would give stakeholders an opportunity to comment and help refine the process. However, the document has gotten completely hung up on the issue of lab-developed tests (LDT). My understanding is that the Office of Management and Budget is holding up the release of the draft guidance document because of its concerns over the backlash from labs and Congress. Many in the industry have been trying desperately to shake the guidance document free, arguing that it really does not need to address the issue of LDTs. They've even proposed simple fixes to un-tether it from the LDT issue, such as a disclaimer that the guidance does not affect LDT policy. It really should be that simple. But alas, so far, no luck?....

Thompson said: In addition to a lack of clarity, one of the biggest challenges is that in the real world, companion diagnostics and drugs are often not developed strictly in parallel. For example, a drug company might develop a drug, and then decide that a companion diagnostic would be useful. So the diagnostic is developed at a later stage. The problems become very logistical because FDA wants to try to shoehorn all development into a strictly parallel process that doesn't always work.