Pharma Companies Now Required to List All Side Effects in Direct-To-Consumer Ads

By Steven Middendorp

President Donald Trump signed a memorandum directing Secretary of Health and Human Services Robert F. Kennedy Jr. to take action on pharmaceutical advertising. The United States is one of only two countries in the world that allow pharmaceutical companies to advertise directly to the consumer. The other one is New Zealand.

The memorandum states, “In 1962, the Congress vested the Food and Drug Administration (FDA) with the authority to regulate prescription drug advertising.  These advertisements can mislead the public about the risks and benefits, encourage medications over lifestyle changes, inappropriately intervene in the physician-patient relationship, and advantage expensive drugs over cheaper generics.”

Secretary Kennedy said the administration will require direct-to-consumer pharmaceutical ads to include all known side effects. The agency is removing the “adequate provision” that passed in 1997, allowing the companies to list just a few side effects in the ad and listing the rest on a website.

“Pharmaceutical ads hooked this country on prescription drugs,” Secretary Kennedy wrote on X. “We will shut down that pipeline of deception and require drug companies to disclose all critical safety facts in their advertising. Only radical transparency will break the cycle of overmedicalization that drives America’s chronic disease epidemic.”

IQVIA, a global healthcare data analytics company, released a 2023 report showing that more than 40% of the $1.7 trillion in global pharmaceutical spending was spent in North America.

The HHS fact sheet states, “The explosion of DTC pharmaceutical advertising following 1997 has led to (1) public deception from patient confusion, (2) patient harm via inappropriate demand for medications and misalignment of therapeutic choices with actual patient needs, and (3) harm to the public finances via misallocation of healthcare resources, including government spending.”

Kennedy stated his intent to ban direct-to-consumer pharma advertising during the presidential campaign before Trump was officially elected and took office for the current term. This kind of ban would receive significant court battles from the pharma industry, arguing that banning one industry from advertising to consumers is a violation of First Amendment rights.

“Many of them didn’t advertise because of what it did to the length of the advertising,” Secretary Kennedy told Fox News. “The FDA changed the rule to allow them to report the side effect on a website or a telephone. They only had to report a few of them on television. That triggered the proliferation of these ads. It’s had a disastrous impact on human health, on people’s relationships with their doctors, and really on the entire gestalt where Americans are led to believe there is a pill for every ill. You don’t have to exercise, you don’t have to pay attention to your diet. Whatever is wrong with you, you can fix with a drug.”

In June, Senator Bernie Sanders called for an end to direct-to-consumer pharma advertising and stated, “Prescription drug commercials now account for more than 30% of commercial time on major networks’ evening news programs.” Sanders said. “Studies have shown that more than half of prescription drug ads are misleading or false, causing many Americans to underestimate the associated risks. Harvard researchers found that the majority of the most advertised drugs had little to no therapeutic benefit compared to existing prescription drugs. America’s seniors are particularly at risk of being misled as pharmaceutical companies strategically target them by pushing high-priced medications that may cause them harm.”

Secretary Kennedy told Tucker Carlson that he went to Fox News with a documentary about mercury and vaccines around 2014. He said that Roger Ailes was completely sold on the documentary and had a family member who had been injured by vaccines. Despite that, Ailes said none of the Fox News hosts could invite him on to speak about the issue because he would have to fire them due to the advertising revenue the pharmaceutical companies provide.

“And he said for the evening news division, about 75% of the advertising revenues are coming from pharma,” Kennedy said. “If I remember it correctly, he said that on a typical evening news show there are 22 ads and 17 of those are pharmaceutical ads. And so this was the principal source of revenue. And for a lot of these television networks, it’s keeping them alive. As you know, they’re all financially collapsing.”

On the same day President Trump signed the memorandum, the FDA announced it had sent 100 cease and desist letters to pharmaceutical companies regarding deceptive ads.

The FDA released a statement explaining that the agency has been lax in its enforcement of the law. In the past, the agency sent about 100 letters to pharma companies each year regarding deceptive ads and these kinds of ads were rare, as a result of the enforcement. The FDA sent only one letter in 2023 and zero in 2024, which has enabled pharma companies to bypass regulatory oversight regarding informed consent in their marketing materials.

“The FDA will no longer tolerate such deceptive practices,” the press release states. “Going forward, the agency will aggressively deploy its available enforcement tools. The FDA is already implementing AI and other tech-enabled tools to proactively surveil and review drug ads.”

Both Senator Sanders and FDA Administrator Marty Makary have stated that Americans pay increasingly high prices for pharmaceutical drugs while the drug companies spend billions on misleading advertisements to consumers.

“For far too long, the FDA has permitted misleading drug advertisements, distorting the doctor-patient relationship and creating increased demand for medications regardless of clinical appropriateness,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Drug companies spend up to 25% of their budget on advertising. Those billions of dollars would be better spent on lowering drug prices for everyday Americans.”