Getting Innovations to Patients During Shutdowns Act
Sponsored By: Representative Mullin, Kevin [D-CA-15]
Introduced
Summary
Continued review of drug and device submissions during funding lapses. This bill would extend the deadline to pay required FDA review fees to 7 days after a lapse in appropriations.
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- Drug and device developers: The FDA could accept complete applications that are missing the fee during a lapse. If the fee is not paid by the extended deadline the FDA would deem the submission not accepted and could not clear or approve it until payment.
- FDA and regulators: The Secretary could keep accepting and processing human drug and device filings during funding lapses, preserving review capability while still requiring eventual fee payment.
- Patients and health systems: By keeping review activity running during shutdowns, the bill could reduce pauses that delay access to new medicines and devices.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 0 benefits, 0 costs, 1 mixed.
Short fee extension for drug and device makers
If enacted, the bill would let FDA accept human drug applications, supplements, and device premarket submissions during an FDA funding lapse even if the filing lacks the required user fee. The filing would need to be otherwise complete. FDA would extend the fee payment deadline to the date that is 7 days after the funding lapse ends. If the fee is not paid by that extended date, FDA would treat the filing as not accepted and would not clear, authorize, or approve it (or any related filing) until the fee is paid.
Sponsors & CoSponsors
Sponsor
Mullin, Kevin [D-CA-15]
CA • D
Cosponsors
There are no cosponsors for this bill.
Roll Call Votes
No roll call votes available for this bill.
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