American Medicine Safety and Security Act
The American Medicine Safety and Security Act would impose strong security-related conditions on employment and work arrangements at the Food and Drug Administration (FDA). The bill would bar certain individuals—specifically nationals of certain foreign countries—from FDA employment or paid work, require staff and contractors to report if they have immediate family members from those countries, prohibit post-employment work with entities based in those countries for a 10-year period, and limit access to sensitive drug and device data for staff with such ties. The definitions used are narrow: “foreign country of concern” includes China, Russia, and Iran, and “immediate family” means a person’s mother, father, sibling, or child. In short, the bill would tighten who can work at the FDA, require disclosure of close family ties to specified nations, restrict long-term post-employment opportunities with entities from those nations, and limit data access for some reviewers and staff based on these ties.
Key Points
- 1Nationals of foreign countries of concern (China, Russia, Iran) would be ineligible for FDA employment or to perform paid or volunteer work for the FDA.
- 2Employees or contractors with an immediate family member who is a national of a foreign country of concern must report that information to the FDA; failure to report could lead to immediate termination.
- 3There would be a 10-year prohibition after employment for FDA staff from working for or providing services (paid or volunteer) for any entity based in a foreign country of concern.
- 4Existing FDA employees (employed before enactment) must agree to the 10-year limitation as a condition of keeping their job; new hires after enactment must agree to the same limitation.
- 5Access to drug or device information would be restricted for staff who have a family member from a foreign country of concern or who previously worked for an entity based in such a country, limiting cross-department data access.
- 6Definitions: “foreign country of concern” = China, Russia, Iran; “immediate family” = mother, father, sibling, or child.