FDA Rules to Expire in 2026

All FDA rules and regulations will expire in 2026.

That is the directive of a rule finalized by the Trump Administration the day before the Biden Administration was sworn in. The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule requires the Department of Health and Human Services (HHS), including the FDA, to review 18,000 existing agency regulations or they will expire in 2026.

Lawsuit: “Ticking Time Bomb”

On March 9, 2021, a group of plaintiffs went to the U.S. District Court in Northern California to argue that the rule is a “ticking time bomb” and will tie the current administration into bureaucratic knots.

The initial notice of the proposed rule came on November 4, the day after the 2020 election, with a public comment period of 30 days. The complaint alleges that the Trump administration rushed the rule through and did not follow legal requirements for the public to be able to weigh in.

Samara Spence, senior counsel at the Democracy Forward Foundation and lawyer for the plaintiffs told National Public Radio, “The promise made in the SUNSET rule is that the [Health and Human Services] department will go through and, one at a time, review all of those regulations. The lawsuit claims the five-year review window for most regulations would require staffers to do this work twenty times faster than has ever been done before.”

“In other words, the outgoing administration planted a ticking time bomb set to go off in five years unless HHS, beginning right now, devotes an enormous amount of resources to an unprecedented and infeasible task.”

The lawsuit states that plaintiffs have no guarantee that HHS will complete retrospective review on such a mass scale “and must assume that any, or all, of the regulations that affect them will disappear…All plaintiffs will have to divert significant resources to monitor the progress of each regulation that affects them and to attempt to stem the effects of potential automatic expiration.”

18,000 Regulations and One-Fifth of the U.S. Economy

Since its inception in 1953, HHS has put approximately 18,000 regulations on the books.

The regulations covered by the SUNSET rule encompass the governance, safety, legality, and effectiveness of:

• health insurance
• hospitals and clinics
• pharmaceuticals and vaccines
• medical devices
• biologics
• mental health treatment
• Medicare and Medicaid
• public health emergency prevention and preparedness
• food safety
• protections for children and the elderly, and much more.

According to the lawsuit, the affected healthcare sector alone accounts for nearly one-fifth of the U.S. economy.

The plaintiffs want the Court to declare that the SUNSET Rule violates the Administrative Procedures Act because it was issued without procedures or consultation required by law, is contrary to law, and is arbitrary and capricious.

Plaintiffs include Santa Clara County, the California Tribal Families Coalition, the National Association of Pediatric Nurse Practitioners, the American Lung Association, the Center for Science in the Public Interest, and the Natural Resources Defense Council.

What happens next? Congress could eliminate the rule through the Congressional Review Act, or HHS could decide to hold off on implementing the rule while the litigation is pending.

If nothing happens, healthcare providers, patients and all the companies that supply them will be spending a lot of money trying to figure out where they stand.