The Office of Information and Regulatory Affairs (OIRA) has finally released the Trump administration’s overdue Unified Agenda of Regulatory and Deregulatory Actions, the document that lists all the updated rulemaking actions each federal agency has undertaken or completed since the last Agenda. Published over a holiday weekend without any acknowledgment from the White House, this Agenda is only the second one the current administration has produced. Traditionally it’s been known as the Semiannual Regulatory Agenda, since Congress actually requires it to be published twice a year.
In 2025 President Donald Trump vowed that for every new regulation implemented, his administration would undo 10 that were already in place. In practice it has been taking more than 100 deregulatory actions for every regulatory one. While some creative math has gone into the claims about the resulting cost savings, it is unequivocally true that Trump has been dismantling the federal government at a pace that far surpasses anything the nation has seen before.
“After four years of stifling overregulation and astonishing government weaponization, 2025 marked the first chapter of the latest American comeback story under President Trump,” Mark Paoletta, general counsel performing the delegated duties of the OIRA Administrator, wrote in the introduction. “Now, the President is writing the next chapter. America is in a new Golden Age.”
Some agencies have few proposed or final rules to report. The Substance Abuse and Mental Health Services Administration only has three, all of which pertain to mandatory workplace drug-testing procedures. The Bureau of Prisons is working on two, a proposed revision to the Prison Rape Elimination Act and another to the First Step Act. The Office of National Drug Control Policy has just one rule in progress, a short item about improving transparency in grantmaking decisions. The Food and Drug Administration has 65.
This rule might result in fewer pharmaceutical ads on TV. It might also result in ads that are a lot longer.
One that the Agenda has labeled “economically significant,” is the proposal to crack down on direct-to-consumer pharmaceutical ads. The extremely American phenomenon of pharma companies using TV commercials to hawk medications to potential patients owes to a 1997 regulatory loophole that allowed potential side effects to be listed somewhere else, rather than during the ad. This meant that companies could fit all the legally required information into a 30-second commercial. The FDA now intends to close that loophole by requiring a “brief summary,” via a final rule that according to the Agenda is slated to arrive in December. This rule might result in fewer pharmaceutical ads on TV. It might also result in ads that are a lot longer.
“FDA anticipates that this rule, if finalized, will result in regulatory costs,” the agency stated in the Agenda. “Industry will face costs of either: 1) purchasing additional advertising time to include required product safety information, 2) dedicating additional advertising time within current advertising time slots toward the newly required information, or 3) the opportunity cost of choosing not to advertise if the cost of inclusion of all newly required safety information induces a decrease or cessation of product advertising.”
The agency pointed out that in 2023 the combined DTC ad spending for the top 10 pharma companies was around $13.8 billion, and that regulation would likely affect international investment and commerce.
“The benefits of this rule are in providing patients more complete safety information during all advertisements covered by the rule, thus improving consumer understanding when they participate in healthcare decision making,” the agency stated. “Risks: TBD.”
Among the Agenda’s updates on other FDA rules, the agency has once again punted its deadline for deciding whether to ban electrical stimulation devices (ESD), which purport to change self-harming or aggressive behavior by delivering shocks through electrodes affixed to the patient’s skin. Autism and intellectual disability advocates have for years testified that ESD are used for torture and punishment, and called on the FDA to remove them from the market. In 2024 the agency committed to reaching a verdict by May 2026. Having not done that, it has now suggested a deadline of November. The devices are still sanctioned at a “behavior modification program” in Massachusetts.
“FDA intends to review the comments received and assess any new data or information in connection with making a determination as to whether the use of ESDs for [self-injurious or aggressive behavior] presents an unreasonable and substantial risk of illness or injury and that the risks associated with ESDs for these intended uses cannot be corrected or eliminated by labeling,” the agency stated. “If FDA makes this determination again, the Agency will issue a final rule to ban these devices.”
The FDA is also considering a regulation that would support “administrative detention of tobacco products … believed to be adulterated or misbranded,” which refers to the agency’s ability to freeze a retailer’s sale of any nicotine vapes to which it hasn’t granted marketing authorization, while the Department of Justice is looped in to explore legal action including permanent seizure of the products. The FDA claims that this would benefit public health through “the illnesses, injuries, or deaths prevented because the Agency administratively detained a tobacco product it has reason to believe is adulterated or misbranded.”
The majority of nicotine vapes that people actually use in the United States—responsible for the rather important public health benefit of reducing the combustible tobacco use that costs almost half a million lives each year—are not FDA-authorized.
“The ability for FDA to issue administration detention orders against new, unauthorized tobacco products, including ENDS, may encourage manufacturers to submit premarket applications requesting authorization for their products to be lawfully marketed, rather than continue to flood the market with additional unauthorized products,” the agency stated.
