How Will Cuts at the FDA Affect Breast Cancer?

If you went for a mammogram or took medicine this year, you most likely trusted you were safe.  That trust is thanks to the Food and Drug Administration (FDA), which has been responsible for ensuring the safety of food, pacemakers, nail polish, cancer drugs, and so much more for decades. For people with breast cancer, the FDA oversees clinical trials, mammogram machines, breast implants, and generics of brand-name drugs. As of 2023, the agency has approved 207 cancer drugs, 39 of which are specifically for breast cancer treatment. 

And like many other federal agencies right now, massive cuts by the Trump administration are threatening the FDA’s very function. 

Since its founding in the early 1900s, the FDA’s main job has been to ensure the safety of anything that could affect human or animal health. According to the FDA, the agency oversaw $3.9 trillion in food, tobacco, and medical products produced in the U.S. and abroad in 2024. The agency’s work affects people living with, treating, and studying breast cancer in a variety of ways.

The FDA ensures that clinical trials are designed and conducted properly and without bias. For example, in 2019, the agency wrote a recommendation encouraging the inclusion of men in breast cancer clinical trials. 

The FDA approves new drugs, vaccines, low-cost generics, and biosimilars. For example, in 2019, the agency approved the Herceptin biosimilar Trazimera.  They also approve medical devices like mammogram machines and scalp cooling systems like DigniCap. 

The agency ensures the continuing safety of drugs and medical devices by monitoring them after they’ve reached the market. Sometimes this results in recalls, like the 2019 recall of the heartburn medication Zantac and the 2019 recall of breast implants from Allergan. The FDA also helps make sure that products that give off radiation, such as medical imaging devices, are safe.

The Department of Health and Human Services (HHS), which oversees the FDA, has undergone significant changes since Robert F. Kennedy Jr. was confirmed as HHS secretary. 

Since RFK Jr. took office, the FDA laid off thousands of its workers. FDA operations rely on people, so fewer FDA workers could result in longer wait times for new cancer drugs or medical devices. Biotech companies that develop drugs have already postponed clinical trials and drug testing because of the layoffs. Changes include:

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  The firing of hundreds of FDA employees in February. Terminated FDA workers included those who had been in the job for two years or less and those who had been recently promoted.

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  The firing of about 20% of FDA staff — or 3,500 people —  in April. These workers included those focused on regulating drugs and communicating recall information to the public. 

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  Several FDA leaders, including a top vaccine expert, have also resigned or retired in the past few months.

As part of the workforce reductions, the office that manages travel operations of safety inspectors was eliminated. Limited travel and fewer safety inspectors could make it difficult for the FDA to do routine health and safety inspections around the U.S. and the world — making drugs and food less safe. 

Martin Makary, MD, MPH, the FDA commissioner, recently outlined the agency’s new priorities in a prominent medical journal. These priorities include increasing the efficiency of drug and medical device approvals using artificial intelligence (AI). The FDA can take months or even years after a new drug application is submitted following phase 3 clinical trials to approve drugs. With fewer workers, the agency is looking to AI to cut down drug approval time. It’s still unclear how these policies will impact breast cancer drug approvals and safety. 

In 2024, the FDA created a Diversity Action Plan to improve diversity in clinical trials by requiring companies to test drugs and medical devices on diverse groups of people. Black and Hispanic Americans are underrepresented in clinical trials, despite experiencing higher disease burdens for diseases like breast cancer. A few days after Trump took office and signed an executive order banning “diversity, equity, and inclusion” initiatives in the federal government, the FDA removed webpages focused on clinical trial diversity. 

If you’re concerned about how cuts to the FDA could affect your community, contact your elected officials to voice your concerns.  To easily find your current elected officials (at the federal, state, and local levels) and their contact info, use Common Cause’s Find Your Representatives tool.