Gottlieb: We need to think differently about how we regulate diagnostics

Scott Gottlieb
FDA Commissioner Scott Gottlieb, M.D. (FDA)

Scott Gottlieb, M.D., wants the FDA to work with Congress to overhaul the regulation of diagnostics. The FDA commissioner thinks revisions are needed to give the agency authorities that are a better fit for modern diagnostics than the current 510(k) pathway.

Talking at a precision medicine panel at the World Economic Forum in Davos, Switzerland, details of which were first reported by Regulatory Focus, Gottlieb sketched out how he wants to change the regulation of diagnostics during his tenure as head of the FDA.

“I think it’s incumbent upon us to think differently about how we regulate diagnostics, and I think it’s time that the agency needs to work with Congress and stakeholders to develop very specific targeted legislation that would give us a unique set of authorities to regulate diagnostics properly. My view is that the old 510(k) PMA pathway ... doesn’t really fit well with modern diagnostics and we need very well fashioned authorities when it comes to diagnostics,” Gottlieb said.


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Gottlieb’s position is underpinned by knowledge of the difficulties companies and the agency have faced in relation to companion diagnostics. In theory, these tests should advance through clinical development, the regulatory process and onto the market in lockstep. But in practice, this has proven to be challenging.

“It’s been a little bit more challenging to define a pathway on how to get regulatory approval for the diagnostic at the same time you get regulatory approval for the drug, in part because a lot of these diagnostic tests have been promulgated as laboratory-developed tests so they haven’t been brought through a traditional regulatory process,” Gottlieb said.

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Some of the issues around companion diagnostics are beyond the FDA’s control. Medicines and diagnostics have fundamental differences that are reflected in the size, skillsets and priorities of the companies that develop them. These differences have historically made companion diagnostic pacts challenging.

The drug and diagnostic industries will need to address some of these issues between themselves. But with Gottlieb heading up the FDA they can look forward to the possibility of the agency working with Congress to clear some of the regulatory obstacles and bottlenecks.   

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