White House pressures FDA on unproven Japanese drug

The White House National Security Council has urged the U.S. government to accept a donation from Avigan in Japan, which would oblige the FDA to issue emergency approval. An official said Abe recently spoke to Trump about the idea and sparked enthusiasm within the administration.

In the meantime, Fujifilm, the FDA and HHS have spent several weeks discussing possible clinical trials with Avigan in the United States. This emerges from an internal summary of the considerations reviewed by POLITICO. The Japanese company is also looking for potential US government funding for its research.

A Trump administration official said the situation is unusual and some National Security Council officials seem determined to help Trump circumvent the regulatory system to achieve his goal of finding a coronavirus cure while others are US – officials feel trapped in the middle.

“There are many concerns about side effects,” said the official, referring to Avigan.

An HHS spokesman said the department could not comment on pre-decision activities. An FDA spokesman also said the agency “will not speculate whether the agency will issue an EUA for a medical device.”

“The FDA continues to work actively with partners from the United States government, science, and regulated industries to accelerate the development and availability of critical medical products to prevent and treat this novel virus,” added the spokesman.

The National Security Council did not answer questions.

Health officials have repeatedly rejected Avigan in the United States despite years of support from Japan and Fujifilm. South Korea officials also refused to use the drug in this country’s coronavirus response this month, warning of insufficient evidence and the risk of “serious side effects”.

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