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www.fdanews.com/articles/213559-api-could-present-national-security-issue-but-thats-a-market-problem-califf

API Could Present National Security Issue, But That’s a Market Problem: Califf

April 22, 2024

The fact that China manufactures almost all of the active pharmaceutical ingredients (API) used to make drugs for Americans could be a threat to national security, according to FDA Commissioner Robert Califf.

“It is a dependence that I think is a national security issue and it’s a clinical issue,” he said during a Thursday hearing of the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies to discuss President Biden’s proposed FY 2025 budget.

Califf pointed out that API originating in China is the chemical backbone for nearly all generic and innovator drugs. “There needs to be a real effort to do something about this,” Califf said.

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