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119-s-2986119th CongressWALLET

American Medicine Safety and Security Act

Sponsored By: Senator Cotton, Tom [R-AR]

Introduced

Summary

Blocks certain foreign-affiliated individuals from working at FDA to protect drug and device safety. The bill would bar nationals of the People’s Republic of China, Russia, and Iran from FDA employment, require staff to report immediate-family ties to those countries, and limit staff access to drug and device information when those ties exist or when the staffer previously worked for entities based there.

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  • FDA workers would face new eligibility and reporting rules. Nationals of the listed countries would be ineligible for paid FDA work, and employees who fail to report an immediate family member who is a national of those countries would be subject to immediate termination.
  • Current and future FDA employees would face a 10-year post-employment ban on working for or volunteering with entities based in those countries, and existing staff must agree to the restriction to keep their jobs.
  • Reviewers and others involved in approval, clearance, licensure, or authorization of drugs or devices would be barred from accessing drug or device information held by other parts of FDA if they have disqualifying family ties or prior paid or volunteer work for entities based in the listed countries.
  • "Immediate family" is defined as the employee's mother, father, sibling, or child.

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Bill Overview

Analyzed Economic Effects

2 provisions identified: 0 benefits, 2 costs, 0 mixed.

New job rules for FDA workers

If enacted, the bill would bar nationals of China, Russia, or Iran from being hired by the FDA or doing paid work for the agency. FDA employees who have an immediate family member (mother, father, sibling, or child) who is a national of those countries would have to report that fact to the FDA. If they fail to report, the Secretary of Health and Human Services would have to end their employment or contract. Existing and new FDA hires would also need to agree not to work, paid or volunteer, for entities based in those countries for 10 years after leaving the FDA.

Limits on FDA reviewers' data access

If enacted, the bill would block FDA reviewers of drug or device applications from seeing drug or device information held outside their office if they have certain foreign ties. Ties include having an immediate family member who is a national of China, Russia, or Iran, or having ever worked or volunteered for an entity based in those countries. This would limit cross-office information access for affected reviewers.

Sponsors & CoSponsors

Sponsor

Cotton, Tom [R-AR]

AR • R

Cosponsors

There are no cosponsors for this bill.

Roll Call Votes

No roll call votes available for this bill.

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