FDA regulations will be slashed in a major overhaul led by HHS Secretary Robert F. Kennedy Jr., freeing healthcare providers from bureaucratic burdens while saving billions in regulatory costs.
At a Glance
- HHS and FDA have launched a Request for Information to identify and eliminate outdated regulations as part of Trump’s Executive Order “Unleashing Prosperity Through Deregulation”
- Kennedy has committed to a “10-to-1” deregulatory policy: for every new regulation, at least ten existing ones will be rescinded
- The initiative aims to lower healthcare costs, remove bureaucratic barriers, and allow providers to focus more on patient care
- A regulatory cost cap will ensure the total cost of new regulations in fiscal year 2025 is “significantly less than zero”
- The public has a 60-day comment period to submit deregulatory suggestions through Regulations.gov
Sweeping Regulatory Reform
The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have launched an ambitious initiative to identify and eliminate burdensome regulations across the healthcare system. This public Request for Information (RFI) represents a cornerstone of the Trump administration’s broader deregulatory agenda, formalized through Executive Order 14192, “Unleashing Prosperity Through Deregulation.” The effort seeks to dramatically reduce regulatory burdens that have accumulated over decades, creating barriers to efficient healthcare delivery and driving up costs for both providers and patients.
“To Make America Healthy Again, we must free our doctors and caregivers to do what they do best—prevent and treat chronic disease,” HHS Secretary Robert F. Kennedy said Tuesday morning. “We cannot allow their time and talent to be wasted on bureaucratic red tape and paperwork.”
The initiative goes far beyond typical government reform efforts. Kennedy has committed to a “10-to-1” deregulatory policy that requires at least ten existing regulations to be rescinded for every new regulation proposed. This aggressive approach signals the administration’s determination to fundamentally transform the regulatory landscape governing American healthcare, with the FDA—responsible for overseeing everything from pharmaceuticals and medical devices to food safety and tobacco products—squarely in the crosshairs.
Concrete Measures to Ensure Accountability
Unlike previous deregulatory promises that often failed to materialize, this initiative includes specific mechanisms to ensure accountability. The Executive Order establishes a regulatory cost cap requiring that the total cost of new regulations in fiscal year 2025 be “significantly less than zero”—meaning regulatory burdens must decrease substantially on net. Furthermore, the scope extends beyond formal regulations to include guidance documents, memoranda, policy statements, and similar directives that often function as de facto regulations without formal oversight.
FDA Commissioner Marty Makary, M.D., M.P.H., has emphasized that the initiative aims to lower healthcare costs, increase access to innovation, and allow clinicians to spend more time with patients rather than complying with unnecessary paperwork. The administration has committed to “radical transparency” through annual reports detailing regulatory costs and identifying specific rules being offset by new proposals—a level of disclosure unprecedented in regulatory reform efforts.
Public Participation and Timeline
A critical component of the initiative is its emphasis on stakeholder input. A 60-day public comment period is currently open, allowing healthcare providers, industry representatives, patient advocates, and ordinary citizens to submit deregulatory action ideas through the Regulations.gov docket or an online portal. This approach recognizes that those working within the healthcare system often have the clearest view of which regulations create unnecessary burdens without meaningfully contributing to patient safety or care quality.
The FDA’s role in this deregulatory push is particularly significant given its vast regulatory authority. The agency is responsible for ensuring the safety and effectiveness of drugs, vaccines, medical devices, the food supply, cosmetics, dietary supplements, radiation-emitting products, and tobacco products. Critics have long argued that while the FDA’s mission is vital, its regulatory approach has grown increasingly cautious and bureaucratic over time, slowing innovation and adding enormous costs that are ultimately passed on to consumers and patients.
The initiative represents a significant departure from the regulatory approach of previous administrations. By focusing on reducing bureaucratic barriers while maintaining necessary protections, the HHS under Kennedy’s leadership aims to create a more nimble, responsive healthcare system capable of addressing chronic disease and delivering high-quality care without the burden of excessive paperwork and compliance costs that ultimately detract from patient care.