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Drug Safety

White House Pressures FDA on Unproven Japanese Drug

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.

Read the source article at Politics, Policy, Political News

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