US President Donald Trump is all set to order his health department to go ahead and crack down on direct-to-consumer (D2C) pharmaceutical advertising as per a new memorandum that was inked on September 9, 2025.
This push, which happens to align with the past pledges that were made from Robert F. Kennedy Jr., the Health and Human Services Secretary, looks forward to boosting the scrutiny of social media companies as well as the influencers who happen to promote the medicines without any sort of proper disclosures, as per a senior administration official who has been granted anonymity so as to discuss the effort.
The FDA, apparently, is also issuing warning letters to certain drugmakers, thereby putting them on notice that D2C pharmaceutical ads have to adhere to the existing regulations. Those rules go on to state that ads cannot come up with a misleading impression of a drug, and they have to present a very fair balance of information pertaining to their risks as well as benefits.
The senior official from the administration confirmed that they were already sending out almost 100 cease and desist enforcement letters along with thousands of warning letters, thereby warning the companies that they plan to enforce these regulations, which are at present on the books.
One of the spokesmen for PhRMA, which happens to be the brand medicine trade lobbying group, remarked that the drugmakers in the brand medicine trade lobby happen to be committed to responsible advertising.
The fact is that truthful and non-misleading DTC advertising happens to be protected under the First Amendment and has documented evidence in terms of advancing patient awareness along with engagement, said Alex Schriver in a statement.
As per the current regulations, drug advertisements should still have to disclose the most important risks of the drugs in spoken form, a disclosure that is known as a major statement.
However, the administration is also looking to take regulatory action so as to change what is called the adequate provision standard. This policy enables the drugmakers to not include all of the drug’s risks when it comes to the broadcast advertisement and rather just tell consumers where they can get more information pertaining to its prescribing data on a source like a website.
The senior administration official said that they plan to take regulatory action in order to change that loophole and then close it, and they do think that by doing these things, this is going to have a major impact on D2C pharmaceutical ads, and that they are going to get back to the foundational principles, which have been pretty much outlined in the original regulations.
The memorandum goes on to state that the FDA has in the past stipulated that a manufacturer, packer, or even, for that matter, a distributor has to provide the public with the materially complete information, which in a way fairly balances the benefits as well as the risks that are associated with the drug. With time, however, the requirements have gone to permit the drug companies to include less of the information, especially when it comes to broadcast advertising, and hence the drug manufacturer advertising has, because of it, seen new highs in recent decades.
Kennedy looks forward to tackling what he describes as overmedicalization when it comes to American children. Research goes on to show that D2C pharmaceutical ads happens to increase the number of drugs as prescribed by doctors. If executed, there would be steeper advertising rules, which could also make it more challenging for the drugmakers to go ahead and market their medicines, thereby potentially reducing the number of prescriptions that are getting written.
As per the strategy pertaining to Make America Healthy Again that was released on September 9, 2025, there is a concerning trend when it comes to overprescribing medications to children, often driven by conflicts of interest within medical research, regulation, and practice. This has gone on to lead to certain unnecessary treatments as well as long-term health risks.
It is well to be noted that lawmakers, when it comes to both sides of the aisle, have gone on to press the FDA in the last few years to go ahead and take enforcement action against the pharmaceutical social media advertisements. The U.S. happens to be one of the two countries in the world, with the other being New Zealand, wherein D2C pharmaceutical ads are widely permissible.
Direct-to-consumer ads that make product claims for disease treatment happen to be only permitted in the United States as well as New Zealand, and the appeal and potency when it comes to D2C ads demand an appropriate FDA oversight, said Sen. Dick Durbin, along with former Sen. Mike Braun, who wrote a letter to Rob Califf, the former FDA Commissioner, in 2024. Unfortunately, it looks like there are indeed certain gaping holes in the oversight of the FDA pertaining to D2C promotions, which are being very much exploited on social media, and that too at the expense of children as well as patients.
