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Regulatory Focus™ > News Articles > Gottlieb in Davos: FDA Needs to Work With Congress on Companion Diagnostic Approvals

Gottlieb in Davos: FDA Needs to Work With Congress on Companion Diagnostic Approvals

Posted 26 January 2018 | By Zachary Brennan 

Gottlieb in Davos: FDA Needs to Work With Congress on Companion Diagnostic Approvals

Industry and government leaders discussed the prospects for precision medicine – a difficult to define but far-reaching buzzword – on Friday at the World Economic Forum in Davos, Switzerland.

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb said: “We have to decide what we mean by precision medicine,” noting the prospects of changing the underlying mechanism of disease or manipulating the underlying mechanism. Often one thinks of gene therapy and CRISPR-Cas9, he added, where efficacy can be identified early, but there’s a distinct set of challenges that need to be carefully considered.

In terms of companion diagnostics, Gottlieb said FDA needs to work with Congress to develop targeted legislation “to give us a unique set of authorities to regulate diagnostics properly…my view is the old 510(k) and PMA [premarket approval] pathways do not really fit well with modern diagnostics.”

Jay Flatley, executive chairman of Illumina, also mentioned the challenges seen in the diagnostics space as small companies can struggle to make it through the regulatory and reimbursement processes while staying afloat.


As far as where industry and FDA are headed, Gottlieb said he thinks “we’re at an inflection point with gene
therapy” noting a study from MIT looking at the next seven years and predicting 40 gene therapy approvals.

“There are a lot of uncertainties, and long-term issues will be most complex for the agency but a lot of opportunity,” he added.

Gottlieb also said FDA is looking to initiate proactive updates on old generic drug labels, which is a contentious issue that the agency has pushed back on deciding on for years.

In terms of steering clinical trials, he said FDA is more focused on long-term durability and off-target effects and will look to earlier approvals based on efficacy with more vigorous long-term follow-up.

Vasant Narasimhan, incoming CEO of Novartis, also noted the opportunities in organizing data with artificial intelligence (AI), but the challenge will be to use it to speed up drug discovery and development.

“I like Garry Kasparov’s idea: If you put a smart person with a smart machine, you can beat a smart person,” Narasimhan said.

He also said he thinks AI “will power our drug development processes pretty soon” and allow companies “to prospectively define high efficacy patient populations.”


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