President Donald Trump has delivered another blow in his ongoing battle with the pharma industry, signing a memorandum on Tuesday that directs the FDA to rein in direct-to-consumer (DTC) drug advertising.
The initiative, which has long been a priority for Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., is designed to roll back a 1997 policy shift that gave drugmakers a greater ability to advertise their products on television by relaxing the requirements on the information they must reveal about a treatment’s side effects.
In his directive, Trump cited the power of the FDA—vested by Congress in 1962—to regulate drug advertisements, ensuring they provide balanced information on benefits and risks of products.
In a separate announcement parallel to the presidential memorandum, the FDA revealed that it was cracking down on deceptive drug advertising and was sending “thousands” of letters warning companies to remove their “misleading” ads. The FDA also said that it issued roughly 100 “cease-and-desist” letters to companies that run deceptive ads.
“For far too long, these ads have distorted the doctor/patient relationship and have created artificial demand for medications regardless of their clinical appropriateness,” FDA Commissioner Marty Makary, M.D., said in a social media post on Tuesday night.
Online pharmacies, which "have been increasingly promoting drugs with no mention of side effects at all,” were among the companies that received the letters, Makary said.
The FDA added that it was working to close the “adequate provision” policy from 1997, which triggered the flood of TV ads.
“Pharmaceutical ads hooked this country on prescription drugs,” Kennedy said in the release. “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.”
By reverting to pre-1997 drug advertising laws, the administration aims to require drugmakers to disclose all product side effects and risks alongside their product promotions. Because ads are usually 30 seconds or a minute long, this would “effectively nullify every pharma commercial in its current form,” Emarketer healthcare analyst Raj Leventhal wrote in an analysis piece.
"However, it’s premature to claim that this is the end of D2C drug advertising,” Leventhal added. “For one, the industry will do everything in its power to challenge any policy changes in court—a tactic that has previously proven successful. Even if pharma companies lost that battle, while the administration’s proposed rules will make it more cumbersome to run prescription drug promotions, it won’t be impossible.”
An outright ban on the advertising of pharmaceuticals would face significant legal challenges, according to Bloomberg Law, as it is considered protected commercial speech under the First Amendment. A ban would likely also exceed the regulatory authority of the HHS, Bloomberg added, and would need authorization from Congress.
If successful, the Trump administration's initiative would remove an effective option from the industry’s marketing toolbox. It would also eliminate a major source of revenue for broadcasters. Last year, pharmaceutical companies spent a combined $10.1 billion marketing their prescription drugs, according to MediaRadar.
“DTC advertising provides patients with important fact-based, useful and accessible information about potential treatment options,” Steven Ubl, the CEO of the Pharmaceutical Research and Manufacturers of America (PhRMA), said in a statement. “PhRMA’s member companies are committed to responsible, accurate advertising that helps Americans make informed decisions about their health care in consultation with their doctor.”
Last year, among the top spending drugmakers individually were AbbVie, which invested $1.2 billion alone on advertising auto-immunology drugs Skyrizi and Rinvoq, and Novo Nordisk, which spent $530 million to market its diabetes and obesity meds Ozempic and Wegovy.