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Steven Mnuchin, Israeli Health Officials Discuss Establishment of Israeli FDA Branch

The FDA, which approves all medical devices and formulations in the U.S., has very few branches outside of the U.S.

Sophie Shulman 11:2729.10.19

Israeli medtech and biotech companies are in line for an early Christmas present. On Tuesday morning, U.S. Secretary of the Treasury Steven Mnuchin met with Israeli health officials and Marius Nacht, co-founder of life sciences and healthcare venture capital fund aMoon, to discuss the opening of a local branch of the U.S. Food and Drug Administration, according to one person who spoke to Calcalist on condition of anonymity. The meeting was held at the house of U.S. Ambassador to Israel David Friedman, and was attended by senior executives from Israeli health maintenance organization Clalit and Sheba Medical Center.

 

The FDA, a federal agency based in Washington, has very few branches outside of the U.S., and those are located in large countries like China, India, and several European and Latin American countries. No company looking to sell medical devices or formulations can operate in the U.S. without FDA approval, and it is an approval process that opens doors for companies globally.  

 

U.S. Secretary of Treasury Steven Mnuchin. Photo: Reuters U.S. Secretary of Treasury Steven Mnuchin. Photo: Reuters

 

 

At first glance, Israel is too small to meet the FDA criteria for a local branch, but the matter is being considered due to the country's unusually large concentration of biotech and medtech companies, the person familiar with the matter said. While it will not replace the need to apply for FDA clearance in the U.S., it could shorten the application process for Israeli companies. Estimates are that such a branch could be established in Israel in the near future, the person said.

 

AMoon is one of Israel’s largest venture capital funds, with over $1 billion in assets under management. Managed by co-founder Yair Schindel, the former CEO of Israel’s National Digital Bureau, the fund invests in multi-stage companies in the domains of digital health, medical devices, and biopharma. Its portfolio companies include gut microbiome analysis company DayTwo Ltd., cancer diagnosis startup Ibex Medical Analytics Ltd., and medical analytics company Zebra Medical Vision Ltd.

 

Nacht started working towards a local FDA branch a year and a half ago, according to the person familiar with the matter. The idea is in alignment with the FDA’s strategy under recently resigned FDA commissioner Scott Gottlieb, who championed cutting bureaucratic red tape for new drug approvals and new regulations meant to cut down the ever-rising price of medication in the U.S.

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