FDA’s New Policy on International Collaborations

Announcement by FDA Commissioner

In a surprising press release last week, FDA Commissioner Dr. Marty Makary revealed that the FDA will prohibit collaborations with certain foreign researchers that involve American cell samples or patient DNA. This decision aligns with the FDA and NIH’s interpretation of executive orders 14117 and 14292, which now restrict the use of American research funding for international projects and ban the exchange of human biological materials with research groups classified as ‘foreign adversaries.’

Concerns Over Past Practices

Dr. Makary expressed concern over previous practices, stating, “The previous administration turned a blind eye and allowed American DNA to be sent abroad – often without the knowledge or understanding of trial participants.” He emphasized the importance of maintaining the integrity of the U.S. biomedical research enterprise, asserting, “We are taking action to protect patients, restore public trust, and safeguard US biomedical leadership.”

References to Foreign Influence

The press release included references to the involvement of the Chinese Communist Party in university and pharmaceutical research. It is important to note that in the U.S., federal and state governments operate universities, regulate research, and collaborate with pharmaceutical companies to develop new drugs and medical procedures.

NIH’s Review of Research Portfolio

In response to the FDA’s actions and recent developments regarding the Biden Administration’s policies, NIH Director Dr. Jay Bhattacharya announced that the NIH is reviewing its entire research portfolio. This evaluation aims to determine whether any federally funded clinical trials utilized exemptions that permitted the export of American biological materials for genetic modification, particularly to entities in countries of concern.

Background on Executive Orders

Executive order 14117, signed in February 2024 by then-President Joe Biden, aimed to ban the sale or export of sensitive personal data to foreign entities to prevent foreign espionage that could compromise sensitive locations like military bases. Additionally, executive order 14292, signed on May 5, 2025, targeted ‘dangerous gain-of-function’ experiments and specified that federal research funding must not be allocated to projects in China. This order also called for special screening of oligonucleotides to ensure they do not pose potential dangers.

Dr. Makary’s Profile

Dr. Marty Makary, a surgeon known for his opposition to COVID-19 vaccine mandates and a prolific opinion writer with an ‘anti-establishment’ perspective, was appointed to lead the FDA by RFK Jr. on April 1, 2025.