Pressures FDA on unproven drug.....

White House pressures FDA on unproven Japanese drug

After Trump's conversation with Prime Minister Abe, aides are seeking an emergency authorization for Fujifilm-owned drug.

By DAN DIAMOND and NAHAL TOOSI

The Trump administration is encouraging regulators to allow a decades-old flu drug to be administered as a possible coronavirus treatment, despite career officials’ concerns about the risks and limited evidence that the drug would work as a coronavirus treatment, according to three officials with knowledge of the deliberations and internal documents reviewed by POLITICO.

Japanese Prime Minister Shinzo Abe has championed the drug, Avigan, as a possible treatment, and clinical trials are now getting underway in Japan. Chinese scientists also have touted the drug, produced by Japan-based Fujifilm, as a potential coronavirus treatment, but global regulators and U.S. researchers have long expressed concern about the drug’s risks, such as birth defects, and have warned that the Chinese data is insufficient.

However, President Donald Trump has embraced a series of unproven drugs as possible coronavirus cures, saying that he has a hunch about anti-malaria drugs that the Food and Drug Administration rushed to authorize for emergency use this week despite scant evidence. Trump also has repeatedly discussed his efforts to encourage FDA approvals of drugs and devices this month, challenging FDA's long-held stance as an apolitical, science-driven agency.

The White House National Security Council has pushed for the U.S. government to accept a donation of Avigan from Japan, the officials said, which would require the FDA to grant an emergency-use authorization. One official said that Abe recently spoke with Trump about the idea, generating enthusiasm within the administration.

Meanwhile, Fujifilm, the FDA and HHS have spent several weeks discussing potential clinical trials of Avigan in the United States, according to an internal summary of the deliberations reviewed by POLITICO. The Japanese company also is seeking potential U.S. 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 work around the regulatory system to achieve his goal of finding a coronavirus cure, while other U.S. officials feel caught in the middle.

"There are a lot of concerns about side effects," the official said, referring to Avigan.

An HHS spokesperson said that the department couldn't comment on pre-decisional activities. An FDA spokesperson also said that the agency "will not speculate on whether the agency would issue an EUA for any medical product."

"The FDA remains actively engaged with partners across the U.S. government, academia and regulated industry to expedite the development and availability of critical medical products to prevent and treat this novel virus ," the spokesperson added.

The National Security Council didn’t respond to questions.

Health officials have repeatedly rejected Avigan in the United States, despite years of advocacy from Japan and Fujifilm. South Korea officials this month also declined to use the drug in that nation's coronavirus response, warning of insufficient evidence and the risk of "serious side effects."

"Avigan has not only not shown efficacy during test studies but also there is not data on clinical trials conducted on patients," Oh Myoung-don, a South Korean infectious disease expert helping lead that country's response, told reporters.

But Trump has supported trying unproven therapies in an attempt to arrest the U.S. coronavirus outbreak, publicly touting two anti-malaria drugs, hydroxychloroquine and chloroquine, as potential coronavirus treatments despite scant evidence. FDA this week granted emergency authorization for the drugs to be used in the coronavirus fight, accepting millions of donated doses, even as career government officials continue to warn that the drugs may not be helpful and that Trump should wait for clinical trials.

“There is no definitive evidence that [chloroquine] works” to fight coronavirus, infectious-disease specialist Anthony Fauci told CNN on Tuesday.

Trump also has publicly discussed his efforts to lean on FDA and its commissioner, Stephen Hahn, in order to speed approvals amid the coronavirus outbreak. The president on Sunday intervened after Ohio Gov. Mike DeWine, a Trump ally, complained that the FDA was limiting an Ohio-based company's efforts to sterilize masks.

“I call up Steve, and Steve says we’ll get it done,” Trump said at a Monday news conference.