The FDA commissioner was busy last week, appearing not just at the POLITICO Pro Policy Summit, but at several other events around town. At Friends of Cancer Research, for example, Gottlieb said he thinks Congress should legislate lab-developed test regulation, as opposed to FDA issuing guidance on the topic. Gottlieb said Congress has done a lot of work in this area and has carefully thought through the issue.
In 2014, the Obama administration tried to exert more regulatory authority over these tests — a type of in vitro diagnostic designed, manufactured and used at just one lab, rather than manufactured and sold widely (which would require FDA approval). But it never finalized the policy after Republicans and some of the test creators expressed outrage.
As FDA waits for Congress to act, Gottlieb said the agency will take incremental steps that will “on a voluntary basis provide more regulatory touch on certain aspects of these tests.” But to regulate optimally in this area, he said FDA “needs a clear legislative framework” to work from, rather than using guidance documents. In late March, Reps. Larry Bucshon and Diana DeGette introduced an LDT bill they hoped to attach to the recently enacted FDA user fee reauthorization. It didn’t make it into that package but Congress is working on other FDA legislation now, including reshaping the over-the-counter drug program, which could make for a logical vehicle.
… Gottlieb also revealed that FDA is working on new drug-specific guidance for Alzheimer’s disease and ALS — two of 10 new disease-specific guidance documents in the works that should help companies design their clinical trials. Gottlieb said he hopes this work will “create more incentives for people to attack these unmet medical needs, because they have clear direction.”