This Act establishes strict employment and post-employment restrictions for FDA personnel with ties to designated "foreign countries of concern" (China, Russia, or Iran) to enhance the security of the drug and device approval process.
Tom Cotton
Senator
AR
The American Medicine Safety and Security Act establishes strict employment conditions for the Food and Drug Administration (FDA) concerning individuals with ties to designated foreign countries of concern (China, Russia, or Iran). This bill prohibits nationals of these countries from working at the FDA and mandates that current employees report immediate family ties to these nations or face termination. Furthermore, it imposes a 10-year ban on former FDA employees working for entities based in these countries and restricts access to sensitive drug and device data for employees with such foreign ties.
New FDA Security Bill Bans Workers with Ties to China, Russia, or Iran, Imposes 10-Year Post-Employment Restriction
The American Medicine Safety and Security Act is taking a hard line on who gets to work at the Food and Drug Administration (FDA), specifically targeting individuals with connections to three countries: China, Russia, and Iran. This bill fundamentally changes employment rules at the agency, citing concerns about national security and the integrity of sensitive drug and device data. In short, if you are a national of one of those three countries, you cannot be employed or contracted by the FDA, full stop (Sec. 2).
The Family Ties Test: Report or Be Fired
This is where the bill gets really serious and hits close to home for current FDA employees. If you work at the FDA, you are now required to report if your immediate family—defined narrowly as your mother, father, sibling, or child—is a national of China, Russia, or Iran (Sec. 2). This isn't just a suggestion; failure to make this report will result in immediate mandatory termination by the Secretary of Health and Human Services. Imagine getting fired because your parent or sibling happens to be a citizen of one of these countries and you missed a required disclosure form. This provision places an extremely high-stakes administrative burden on thousands of federal employees, punishing them severely based on family association rather than their own actions.
The 10-Year Career Freeze-Out
For anyone working at the FDA from the day this bill passes, a significant new restriction kicks in: a 10-year ban on working for or even volunteering for any entity “based in” China, Russia, or Iran after you leave the agency (Sec. 2). This applies to everyone—from the newest hire to the most seasoned expert. If you’re a long-time FDA scientist who specializes in medical device approval, and you wanted to retire and consult for a global firm that happens to have an office based in Shanghai a few years later, this bill could block that move for a full decade. The bill requires existing employees to agree to this post-employment restriction just to keep their current job, effectively forcing a choice between their present career and future professional freedom.
Data Access Based on Association
Beyond employment and post-employment restrictions, the bill also limits who can see what inside the FDA. If you have an immediate family member who is a national of one of the designated countries, or if you yourself previously worked or volunteered for an entity based in one of those countries, your access to sensitive drug or device data is restricted (Sec. 2). You can only access data held by the specific FDA department that employs you; no looking at data in other offices. While the intent is clearly to protect intellectual property and regulatory secrets, this restriction could hamstring experienced analysts and scientists whose job requires cross-departmental data review. It creates a two-tiered system where some highly qualified employees might be unable to perform their full duties simply because of their family history or past professional life.