Prescription drug ad regulation
Should prescription drug advertising be more strictly regulated? Viewpoints from multiple sides.
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What’s happening
On Sep 9, President Trump issued a memorandum directing the Department of Health and Human Services (HHS) to “ensure transparency and accuracy” in direct-to-consumer (DTC) prescription drug advertising, including by requiring that prescription drug ads contain a greater amount of information around any associated risks. The memorandum also directed the Food and Drug Administration (FDA) to enforce that prescription drug ads are truthful and not misleading.
Pharmaceutical ads in the US: The US is one of only two countries in the world that allows for DTC pharmaceutical ads, such as on TV or social media (New Zealand is the other). The first television commercial for a prescription drug in the US aired in 1983. The FDA immediately ordered the ad be taken down, as the ad did not represent a “fair balance” between the drug’s risks and benefits. The FDA called for a voluntary moratorium on DTC media ads for prescription drugs from 1983-1985. In 1985, the FDA rescinded the moratorium, allowing pharma ads on TV, but with strict requirements that ads disclose information about all possible risks associated with a medication.
In 1997, the FDA loosened its disclosure requirements for DTC pharma ads. In what is known as the “adequate provision” guideline, the FDA said that TV and radio prescription drug ads were required to only disclose the “major statement” of key risks and not list all possible side effects. The FDA’s ruling led to a surge of DTC pharma advertising in the United States. It jumped from $1.3B in 1998 to $3.3B in 2005. In 2024, pharma firms spent $10.8B on DTC ads.
What happens now: Following Trump’s memorandum, the HHS issued a release in which it said it is returning to its pre-1997 position on pharmaceutical ads, and that it will “require drug companies to include full safety warnings,” including full contraindications, boxed warnings, and common precautions on all DTC ads. The FDA said that it has sent thousands of letters to pharma companies – including Eli Lilly, Novo Nordisk, and Hims & Hers Health – warning them “to remove misleading ads.” The FDA also said it sent roughly 100 cease-and-desist letters to pharma firms “with deceptive ads.” Firms reportedly have 15 working days to respond to the letters, after which the FDA could seek legal action if violations are not fixed, including seizure or injunction.
Trump’s memorandum has intensified a debate over how stringently drug advertising should be regulated in the US. Today, we bring you viewpoints from multiple sides. Let us know what you think.
Notable viewpoints
More opposed to stricter regulation of DTC pharma ads:
The new memorandum violates US laws.
Since requiring additional disclosures may make some ads too long to be feasible – as the FDA commissioner has admitted – the government is indirectly banning free speech for pharma companies through obstructions, which it is not allowed to do. The FDA is using a backdoor to avoid outwardly violating the First Amendment.
The new disclaimer mandates go against US statute. National Institute of Family and Life Advocates v. Becerra (2018) determined that speaker-based laws designed to drown out the speaker’s intended message were not legal. Moreover, in Americans for Prosperity Foundation v. Bonta (2021), the Supreme Court ruled that disclosure laws must be “narrowly tailored” to an acceptable governmental interest, and the White House’s desire to curtail corporate speech with intentionally elongated disclaimers is not acceptable nor “narrowly tailored.”
This is illicit censorship – United States v. Caronia (2012) ruled that banning and criminalizing truthful off-label promotional pharma ads violated the First Amendment. While pharma ads are a unique phenomenon to the US, this doesn’t make them wrong or illegal.
Pharma ads help improve the health of Americans.
Pharma advertising makes the US more healthy, not less. For instance, a 2023 study by University of Pennsylvania researchers found DTC advertising increased treatment initiation and medication adherence among Medicare Part D participants. Drug ads help people get diagnosed and treated for chronic conditions, and a drop in DTC advertising would reduce America’s overall welfare.
The new advertising rules set a dangerous precedent for censoring other industries.
Stricter regulation of pharma ads is a Trojan horse for the government to later censor other industries that it deems pose a public health emergency. If the government can impose bureaucratic censorship to suppress pharma ads it dislikes today, it will use that same authority against other sectors such as energy companies tomorrow.
More supportive of stricter regulation of DTC pharma ads:
Pharma ads are deceptive, and imposing restrictions on them does not violate the First Amendment.
The FDA is not banning pharma ads – that would violate the First Amendment – but the First Amendment does not protect deceptive marketing. Pharma ads have misled American patients, distorted the patient-doctor relationship, strained the health care system by increasing the rate of inappropriate medication use, and driven unnecessary spending. These ads must be regulated so that decisions about prescription medication depend on patients and their doctors, not on advertising.
Drug ads are an inherently limited, biased, and problematic way to educate people about prescription medication – they encourage patients to get medication they may not need, and they drive the overprescribing of expensive drugs when cheaper, equally effective generic treatments exist.
The White House is right to impose accuracy and transparency requirements on pharma ads, which intentionally deceive patients as part of their marketing strategy and should be removed from TV and the internet altogether. This is not an issue of free speech – the US had just as much freedom of speech, if not more, in the 1960s and 1970s before pharmaceutical ads existed.
Pharma ads negatively impact the health of Americans.
DTC pharma ads can negatively impact Americans’ health by influencing how they select medications. According to one 2023 study, two-thirds of DTC pharma ads run between 2015-2021 featured medications that had low therapeutic value. Another 2023 study found that pharma firms spend the most on advertising medications with the fewest benefits. This memorandum is a welcome step towards weakening Big Pharma’s influence over Americans’ health decisions.
Today's pharma ads do not adequately present the risks associated with taking prescription medications. Moreover, pharma ads online or posted by social media influencers frequently only share the upsides of a drug, contributing to America’s pill-popping culture. Encouraging Americans to take drugs instead of making lifestyle changes will not make America healthy.
Be heard
We want to hear from you! Comment below with your perspective on Trump’s memorandum to tighten restrictions on drug advertising and we may feature it in our socials or future editions. Below are topic ideas to consider.
Do you agree with imposing more stringent regulations on pharmaceutical ads? Why or why not?
What are some arguments or supporting points you appreciate about a viewpoint you disagree with?
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