Canadians could lose vital safety information amid deep cuts to the U.S. FDA, experts warn

A sign for the Food and Drug Administration is displayed outside their offices in Silver Spring, Md., on Dec. 10, 2020. (AP Photo/Manuel Balce Ceneta, File)

Canadian health experts warn the fallout from thousands of job cuts at the U.S. Food and Drug Administration on April 1 could disrupt the flow of safety information on drugs, medical devices, and food to Canada.

For years, Canadian agencies responsible for monitoring food and pharmaceutical safety have worked closely with regulators around the world. The U.S. Food and Drug Administration’s (FDA) vast resources and global influence have played a role in informing decisions in Canada on issues such as safety warnings and recalls of dangerous foods and drugs from the market.

However, sweeping changes to the FDA since U.S. President Donald Trump took office could impact the benefits Canada derives from this historic collaboration, reducing the quality and availability of information about harmful drugs and food products—potentially allowing serious health risks to go undetected and products to remain on the market longer.

The U.S. Department of Health and Human Services (HHS), now headed by Robert F. Kennedy Jr., laid off 10,000 workers as part of Elon Musk’s Department of Government Efficiency task force. The department plans to cut 3,500 jobs directly from the FDA.

A ‘huge problem’

While a memo on the restructuring claimed that layoffs wouldn’t affect reviewers or inspectors of drugs, medical devices, or food, reporting in the U.S. revealed that these areas are being impacted. Reported job losses include lab scientists who tested food for contaminants including deadly bacteria, scientists at drug safety labs, and staff in the drug inspections and investigations office, among many others.

“I think this is a huge, huge problem,” said Matthew Herder, a professor of law and medicine at Dalhousie University who specializes in regulation of pharmaceuticals. He told CTVNews.ca in an interview that Canada has long benefited from the FDA’s size and reach.

Just days after the initial firings, Kennedy Jr. reported that 20 per cent of layoffs were “mistakes,” saying some personnel would be reinstated. But for close observers, the damage has already been done.

“The FDA as we’ve known it is finished, with most of the leaders with institutional knowledge and a deep understanding of product development and safety no longer employed. I believe that history will see this a huge mistake,” wrote Dr. Robert Califf, a former commissioner of the FDA under President Joe Biden on LinkedIn.

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Canada has historically benefited from U.S. post-market surveillance—the ongoing monitoring of drugs and medical devices after they’ve been approved—to detect safety issues that may not have surfaced during clinical trials. “They just have vastly more resources,” said Herder. “The chances of us picking up something before the U.S. are very slim.”

For example, in 2017, Health Canada issued a safety review and letter to health professionals for commonly used antibiotics, fluoroquinolones, following a review by the FDA, warning of a potential risk of “disabling side effects” from tendonitis or nerve damage.

In 2019, Health Canada recalled surgical mesh for transvaginal repair of pelvic organ prolapse following a U.S. recall. Canadian women had reported debilitating side effects, including urinary problems, mobility challenges, emotional distress, and discomfort during sex associated with this medical device.

Diana Zuckerman, the president of The National Center for Health Research in Washington, D.C, called the staff cuts at the FDA a disaster: “you can’t cut 20% of their staff and think it’s not going to have a tremendous impact.”

She said in an interview with CTVNews.ca that post-market surveillance is already under-resourced and worries it will be weakened further by the cuts.

Herder said less surveillance of approved drugs is particularly concerning given the trend in recent years of letting more drugs into the market with less evidence. “If we’re losing the oversight that the FDA offers globally or losing even the percentage of it, that is really terrifying.”

CTVNews.ca asked Health Canada, responsible for drug and medical device safety, about the concerns raised by experts that a diminished FDA could pose risks to Canadians, but the agency declined to comment.

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Canadian outbreaks could ‘go totally unnoticed’

Canada has also long collaborated with American agencies for food safety. Keith Warriner is a food safety professor in the Department of Food Science at the University of Guelph. Despite the Buy Canadian movement, he believes imports from the U.S. will continue to be a significant source of food in Canada.

He said American agencies, including the FDA, Centers for Disease Control and Prevention, and the United States Department of Agriculture, have been particularly good at surveillance, and Canadians have benefited from information sharing.

“When an outbreak occurs, they’re pretty hot on it. In Canada, we could get outbreaks that go totally unnoticed,” Warriner told CTVNews.ca. Often recalls and alerts originate with American products and are adopted in Canada, meaning that a delayed response in the U.S. could also impact Canadian consumers.

His biggest concern about the changes to the FDA is that the U.S. might reduce food safety surveillance, and “if they cut back on that, then it’d be outbreaks running rampant.” He suspects the deep cuts will lead to fewer recalls due to a decrease in outbreak detection.

The New York Times reported that nearly all staff in the Office of Policy and International Engagement were laid off; this office was responsible for sharing data on foodborne illnesses detected abroad before affected products reached the United States, indicating international collaboration is already being impacted. The Canadian Food Inspection Agency (CFIA) also declined CTVNews.ca’s request to comment directly on concerns that changes at the FDA could impact Canadians, but said in an emailed statement it “remains proactive in tracking changes in the U.S. and other exporting countries and will take any necessary action to continue to protect the health of Canadians and maintain a safe food supply.”

Dr. Joel Lexchin is concerned that, given the climate of U.S.-Canada relations, pharmaceutical information sharing could be reduced. The retired emergency room doctor and a former professor at York University who has been researching pharmaceutical policy in Canada for more than 40 years told CTVNews.ca, “if the FDA keeps data to itself, unsafe products may remain on the Canadian market for longer than they currently do.”

He would like to know how the historically collaborative relationship between the FDA and Health Canada is currently operating and how Health Canada plans to fill in any gaps left by potential changes in information sharing.

Health Canada declined to answer questions on whether there have been any changes in the collaboration with the FDA. It also did not respond to questions on how it would fill any potential gaps in oversight and surveillance of drugs or devices.

However, Health Canada Senior Communications Advisor Karine LeBlanc said in an email that the department “will continue to engage and build on existing cooperation with them (FDA) in order to protect and advance the health and safety of the people in Canada.”