Getting Innovations to Patients During Shutdowns Act

This legislation aims to ensure the continuous review of human drug and device applications by the Food and Drug Administration (FDA) even during periods of government shutdowns or lapses in appropriations. It introduces a special rule allowing the FDA Secretary to accept drug applications or supplements that are complete except for the required user fee payment during such financial interruptions. This measure prevents critical review processes from halting due to temporary funding issues. For both drug and device submissions, the bill extends the deadline for fee payment to seven days after the appropriations lapse concludes. However, if the fees are not paid by this extended deadline, the application or submission will be considered incomplete and not accepted. Crucially, the FDA is prohibited from clearing, authorizing, or approving any such application or related submission until all outstanding fees have been fully paid.