To amend the Public Health Service Act to remove certain liability protections for certain biological products and other drugs if the sponsor thereof fails to disclose to the public all non-exempt data within the biological product file or drug application, and for other purposes.
This bill would require pharmaceutical manufacturers to publicly disclose all non-confidential data from vaccine and drug applications within 10 days of receiving emergency use authorization from the FDA, or face loss of liability protections. The legislation applies to biological products and drugs authorized for emergency use on or after the bill's enactment, regardless of whether they later receive full FDA approval. Manufacturers would post this data on their own websites, and the Department of Health and Human Services would also post it on a government website. Companies that knowingly fail to disclose required information would become ineligible for federal grants, contracts, and new emergency authorizations, and injured parties could sue the government if HHS fails to post the required information.
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