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<Research>JPM: US House Lawmaker Proposal Urging FDA to Reject China-Generated Clinical Data Not Incorporated into Appropriations Bill; Investors Advised Not to Act Immediately
The House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies proposed calling for the FDA to not review or consider c...
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<Research>JPM: US House Lawmaker Proposal Urging FDA to Reject China-Generated Clinical Data Not Incorporated into Appropriations Bill; Investors Advised Not to Act Immediately
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The House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies proposed calling for the FDA to not review or consider clinical data generated in China in drug trial applications (investigational new drug applications, INDs) in the US, a JP Morgan report said.

The broker viewed the proposal is unlikely to have a substantive impact on Chinese biotechnology and pharmaceutical companies or on FDA drug trial applications at this stage. It advised investors to monitor developments but not to take immediate action.

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The broker noted that the proposal targets an appropriations bill submitted to the House of Representatives, but the bill text does not mention clinical data and therefore carries no legal effect. Unless the amendment is formally incorporated into the bill text and passed into law, the FDA is not required to take any action.

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