FDA halts clinical trials shipping American cells overseas due to national security risks – NaturalNews.com

• FDA under Trump halts trials sending U.S. cells to “hostile” countries like China for genetic engineering.
• Security concerns include foreign misuse of DNA and lack of patient consent.
• Previous Biden-era exemption allowed transfers without proper oversight.
• NIH joins review of federally funded research linked to the exemption.
• New policies require transparency in consent and bioengineering oversight.

The Food and Drug Administration (FDA) announced June 18 the immediate suspension of all new clinical trials involving the transfer of American patient cells to foreign laboratories in “hostile” countries, citing concerns over national security and informed consent. The move comes after FDA leaders discovered a loophole in a Biden-era data security rule that permitted U.S. companies to send biological materials — such as DNA samples — to nations like China for genetic engineering as part of FDA-regulated trials. FDA Commissioner Dr. Marty Makary and Deputy Director Dr. Vinay Prasad warned that the practice exposed patients to unknown risks while enabling foreign governments to access sensitive genetic data. The agency now requires clinical trial sponsors to demonstrate transparency, secure handling of materials and robust consent processes for trials to resume, signaling a sharp pivot toward stricter oversight of biomedical research.

FDA takes strident action: Closing the “national security blind spot”

The FDA’s directive stems from investigative findings that some trials did not inform patients their cells, collected during treatment or research, were being sent abroad for modification. Dr. Makary stated the agency “only learned about the loophole this week,” calling it an egregious failure of prior administrations to protect American interests. “Foreign entities could engineer cells to target specific tissues, and we might not even know what’s coming back,” Dr. Prasad warned, emphasizing risks of bioweapon applications.

The halt targets trials relying on a Biden-authored data security rule, finalized in 2024, which allowed conditional transfers of biological samples to foreign labs for research. While the rule banned sensitive data exports to adversaries like China, it permitted exceptions for clinical trials regulated by the FDA — a gap the agency now deems unacceptable.

Concerns over bioengineering and data misuse

Beyond physical material risk, the FDA and National Institutes of Health (NIH) highlighted ethical failures in participant consent processes. “Patients may have their cells modified in ways they didn’t agree to and don’t understand,” Dr. Makary said. The agency’s statement accused foreign labs of exploiting the exemption to collect genetic information, raising the specter of identity theft or biometric targeting. NIH Director Dr. Jay Bhattacharya called the loophole an “unacceptable risk,” vowing to sever funding to trials found out of compliance.

National security analysts echoed these anxieties. “Chinese actors have long sought to exploit U.S. biomedical research gaps,” noted Dr. Elizabeth Dibble, a defense policy scholar. “This is a critical intervention to prevent foreign intelligence collection.”

A decade of tensions in biomedical research security

This crackdown revisits debates dating to the Obama and Trump eras over balancing scientific collaboration with China and national security. In 2018, U.S. intelligence agencies flagged Chinese labs stealing U.S. genetic research, and in 2021, NIH officials temporarily paused select joint studies. More recently, Biden’s 2024 Executive Order 14117 aimed to restrict sensitive health data exports but carved out exceptions for clinical trials — an exclusion now under scrutiny.

The FDA’s actions mirror President Trump’s 2025 Executive Order 14292, which directed agencies to end federal funding for unlabeled overseas research. Together, these orders reflect a bipartisan rise in urgency over foreign threats to U.S. scientific data.

Reaction and next steps: A shift toward transparency in science

Industry groups responded mixedly. The Biotechnology Innovation Organization stated, “Ethical research must proceed safely,” while emphasizing that most trials comply with consent rules. Patients’ advocates praised the move. “No one should have foreign labs altering their cells without knowing it,” said Megan Sun, CEO of the Center for Patient Autonomy.

The FDA and NIH will now audit trial sponsors, requiring them to file revised protocols by July 31. Those failing to meet transparency criteria face deactivation. “The science we permit must first prioritize the safety and sovereignty of the American people,” Dr. Makary declared.

A new era of oversight for America’s research frontier

The FDA’s bold move underscores a growing recognition: Biomedical innovation cannot overlook security and consent. With federal agencies harmonizing oversight, the incident signals not just closure of a single loophole but a recommitment to safeguarding American data in an era of escalating global competition. As Dr. Bhattacharya noted, “Science without oversight isn’t progress — it’s peril.” The agency’s actions, though delayed, aim to ensure that U.S. research retains public trust and global leadership.

Sources for this article include:

JustTheNews.com

TheEpochTimes.com

THXnews.com