Authored by Lawrence Wilson via The Epoch Times (emphasis ours),
President Donald Trump has directed the Food and Drug Administration (FDA) to ramp up its efforts to ensure that advertising of prescription drugs directed to consumers is transparent and accurate.
That includes requiring drug makers to provide more information on the risks of using the drug, and stepping up enforcement of federal laws regulating these ads.
This action, ordered by a presidential memorandum on Sept. 9, could have far-reaching implications for drug manufacturers, who collectively spend billions each year to present their products directly to prospective patients through broadcast media.
The ripple effect could impact new media, as the FDA ramps up enforcement in digital spaces, including via social media influencers, algorithmically served ads, artificial intelligence (AI), and chatbots.
Here’s what to know.
Direct-to-Consumer Ads Skyrocket
Direct-to-consumer advertising for prescription drugs has been regulated by the FDA since 1962 but was not generally used until the mid-1980s. At that time, lengthy descriptions of a drug’s risks and possible side effects were required in each ad.
The practice expanded rapidly starting in 1997, when the FDA added a provision allowing pharmaceutical companies to broadcast ads that included only the most important risks while referring consumers to other sources for more complete information.
This “adequate provision” of risk information could be as simple as including a toll-free phone number or website URL in the ad, or telling consumers to consult their doctor.
Since then, direct-to-consumer drug advertising has grown to a $13.8 billion business as of 2023.
In 2024, seven companies spent a combined $3.3 billion to advertise 10 medications. The top advertiser, AbbVie, spent nearly $1.4 billion to promote the use of Skyrizi, Rinvoq, and Vraylar.
Drug companies maintain that their ads are accurate and helpful.
Pharmaceutical Research and Manufacturers of America, an industry trade group, stated: “[Direct-to-consumer advertising] provides patients with important fact-based, useful and accessible information about potential treatment options.”
The Sept. 9 statement added that member companies are committed to responsible advertising practices that help Americans make informed health care decisions with their doctors.
The United States and New Zealand are the only countries to allow direct-to-consumer prescription drug advertising.
Impact of Consumer Ads
The Trump administration maintains that the practice of omitting much of the risk information from broadcast advertising has negatively affected the health of Americans.
Researchers Janelle Applequist and Jennifer Gerard Ball found that most prescription drug ads—94 percent—relied on positive emotional appeals and did little to educate the consumer.
According to the FDA, advertising generates patient-physician conversations that emphasize the use of medication over lifestyle changes that might be equally beneficial.
One concern is that the ads may lead patients to ask for a prescription that their physicians are not convinced is medically appropriate. A 2002 study published by BMJ concluded that when patients requested a drug, “In most cases physicians prescribed requested medicines but were often ambivalent about the choice of treatment.”
A year later, a study published by the Journal of Medical Economics concurred that exposure to advertising “led to large increases in treatment initiation.”
However, that study reported that advertising also improved patients’ compliance with their prescribed medication regimen. Other researchers have said that direct-to-consumer ads may reduce the chance of illnesses going undiagnosed.
Prescription drug use has increased dramatically in the United States over the last 30 years, to the point where children born in 2019 can expect to spend roughly half of their lives taking prescription medications, according to Jessica Y. Ho, a researcher at Penn State University.
What FDA Will Do Now
First, the FDA will introduce a new federal rule to remove the 1997 Adequate Provision exception. That would likely mean that broadcast prescription drug ads will again have to include a fuller listing of risks and side effects of using a medication.
Federal rulemaking can be a lengthy process, taking one to three years to complete.
In the meantime, the FDA will ramp up enforcement of existing federal laws regulating consumer ads for prescription drugs.
The FDA noted that enforcement letters, a first step in gaining compliance with a regulation, numbered about 130 each year in the late 1990s. In 2023, the agency sent only three enforcement letters.
Federal officials sent 100 letters to drug companies on Sept. 9, advising them to comply with current federal regulations for direct-to-consumer prescription drug advertising.
The FDA said it would also issue dozens of enforcement letters targeting “false and misleading advertising” that “misbranded” drugs. The FDA can take a variety of enforcement actions related to a misbranded drug, including recalls, seizures, and civil penalties. Serious cases of misbranding could result in criminal charges.
Also, the FDA will expand its oversight of direct-to-consumer advertising of prescription drugs to include social media. That includes influencer partnerships, sponsored content, targeted ads, AI-generated content, and chatbots.
Other Administration Actions
The executive memorandum differs from an executive order in that it does not have the force of law. This is the latest action by the Trump administration aimed at pharmaceutical industry reforms.
Earlier on Sept. 9, the Make America Healthy Again Commission released its strategy report, stating its intention to evaluate the impact of current diagnostic thresholds and prescription trends on children’s mental health.
In July, the president asked U.S. drug makers to comply with his Most Favored Nation Prescription Drug Pricing policy, ensuring that U.S. consumers pay the lowest available price for prescription medications.
Manufacturers have said that if they lower prices in the United States, they will not be able to recoup research and development costs for expensive drugs.
Americans pay nearly three times as much for prescription medication as any peer nation, often even more.
An April executive order included actions to ensure that pharmacy benefit managers, the middlemen in the drug supply chain, can’t hold on to rebates provided by pharmaceutical companies and instead must pass savings on to Medicare beneficiaries.
A spokesperson for Novo Nordisk referred The Epoch Times’ request for comment to Pharmaceutical Research and Manufacturers of America. AbbVie, Johnson & Johnson, and Sanofi did not reply to requests for comment by the time of publication.
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