H.R. 9635: Getting Innovations to Patients During Shutdowns Act

This bill would change how the Food and Drug Administration (FDA) handles certain drug and medical device reviews during a federal funding lapse, such as a government shutdown.

What it does

The bill would let the FDA keep accepting and processing some human drug and medical device submissions even if there is a lapse in appropriations for the FDA or for the fee collection programs that help fund review work.

Drug applications

For human drug applications and supplements, the FDA could accept a submission even if the required user fee has not yet been paid, as long as the application is otherwise complete. The bill would give the applicant until 7 days after the shutdown ends to pay the fee.

If the fee is not paid by that deadline, the FDA would have to treat the application as incomplete and not accepted, and it could not approve or otherwise clear the application until the fee is paid.

Medical device submissions

The same basic rule would apply to certain medical device submissions, including premarket applications. During a lapse in funding, the FDA could accept a submission that is complete except for required fees, and the fee deadline would be extended to 7 days after the shutdown ends.

If the fee is still unpaid after that extended deadline, the FDA would have to deem the submission not accepted, and it could not clear, authorize, or approve the submission until the fee is paid.

Practical effect

In simple terms, the bill is meant to prevent FDA review of certain drug and device filings from stopping entirely during a shutdown. It would allow companies to keep moving forward with submissions, while still requiring the fees to be paid shortly after normal operations resume.

Relevant Companies

Likely impacted public companies include firms that regularly submit drugs or devices to the FDA for approval or clearance, since the bill could affect timing of review during shutdowns:

• LLY — Eli Lilly and Company; could benefit from continued FDA review timelines for drug applications during a funding lapse.
• PFE — Pfizer Inc.; may be directly affected by how quickly drug submissions can be accepted and reviewed during a shutdown.
• MRK — Merck & Co., Inc.; could be affected if drug application reviews proceed during lapses in appropriations.
• MDT — Medtronic plc; could be impacted by continued FDA handling of device submissions during shutdowns.
• BSX — Boston Scientific Corporation; may be affected by the timing of FDA device review and clearance processes.
• ABT — Abbott Laboratories; could be directly impacted through its medical device and diagnostics submission pipeline.
• ISRG — Intuitive Surgical, Inc.; could be affected by FDA review of device-related submissions.