Do we need fewer regulations? Who should point out which ones should go? Who is the target of this reduction in regulation, the industry or the healthcare community? The U.S. Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) announced a major new initiative this week whereby the public can list the regulations they want gone. However, whether these are aimed at the industry or the healthcare community is unclear.
At the heart of this initiative is the new “10-to-1” policy, under which HHS will eliminate at least ten existing regulations for every new one proposed. The announcement claims this would streamline government oversight and slash compliance costs for doctors, nurses, and other health care providers. Robert F. Kennedy, Jr., the Secretary of DHHS, emphasized that this deregulatory push is essential for improving national health outcomes. “To make America healthy again, we must empower our medical professionals to concentrate on preventing and treating disease, not waste their talents on navigating endless red tape,” said Kennedy. FDA Commissioner Dr. Marty Makary added, “This is about restoring common sense,”. He said “By eliminating outdated rules, we reduce costs, encourage innovation, and give clinicians more time to focus on patients rather than paperwork.”
This is a sweeping move, one that could potentially put several regulations on the chopping block. This represents one of the most aggressive deregulatory policies in modern federal history. In addition to the 10-to-1 requirement, the initiative includes three powerful provisions:
- A Regulatory Cost Cap: The total cost of new regulations in fiscal year 2025 must fall below zero. This means any new rule must be offset by cost-saving eliminations.
- Expanded Oversight: The reforms apply not only to traditional regulations but also to Guidance Documents, informal agency guidance, policy memos, and internal directives that often escape public scrutiny.
- High Transparency: HHS will release annual reports detailing the financial impact of its regulatory changes and specifying which rules have been repealed.
To ensure the effort reflects real-world needs, the agencies have launched a 60-day public comment period. Stakeholders, including health care professionals, industry leaders, and the general public, are invited to submit suggestions for regulations that should be revised or removed. Feedback can be submitted online at Regulations.gov/Deregulation, which includes templates and tools to help draft proposals.
This could make the regulations more friendly to smaller pharma companies, according to the Secretary and the Commissioner. The FDA and HHS do not regulate medical practice directly; the medical boards do. But all changes to FDA regulations would affect healthcare providers by providing access to treatments. A similar policy implemented in the last Trump administration did not do much. It seems more aggressive this time. We will have to wait and see how this pans out.
