Direkt an Verbraucher gerichtete Arzneimittelwerbung steht in der Kritik – Pharmaunternehmen sollten sich in Acht nehmen
On June 12, 2025, Senators Bernie Sanders (I-VT) and Angus King (I-MN) introduced the End Prescription Drug Ads Now Act (the Act) that would prohibit pharmaceutical companies and arguably any other entity engaged in advertising drugs, including telemedicine companies, from conducting direct-to-consumer (DTC) advertising of prescription drug products.
If signed into law, the Act would amend the Federal Food, Drug, and Cosmetic Act (FD&C Act) at 21 U.S.C. § 352 (titled “Misbranded drugs and devices”) by adding the following language to the end of the section that begins with “A drug or device shall be deemed to be misbranded—:
(hh)(1) If it is a drug approved under section 505 or licensed under section 351 of the Public Health Service Act, and subject to section 503(b)(1), and the holder of the approved application under section 505 or of the license under such section 351 has conducted direct-to-consumer advertising of the drug within the most recent 30-day period.
(2) For purposes of this paragraph, the term ‘direct-to-consumer advertising’, with respect to a drug subject to section 503(b)(1), means any promotional communication targeting consumers, including through television, radio, print media, digital platforms, and social media, for purposes of marketing such a drug.”
There are three notable definitions in the Act worthy of discussion:
1. What is a “drug approved under section 505 or licensed under section 351 of the Public Health Service Act, and subject to section 503(b)(1)?”
New prescription drugs are typically approved under section 505 of the FD&C Act (21 U.S.C. § 355), which allows for the approval of a new drug application following demonstration of a drug’s safety and effectiveness, whereas biological products such as vaccines, blood, and protein products are licensed under section 351 of the Public Health Service Act (PHSA) (42 U.S.C. § 262). Drugs subject to section 503(b)(1) of the FD&C Act (21 U.S.C. § 353b) are those limited to being dispensed by prescription (and thus would not cover over-the-counter drugs approved under section 505). Taken together, the proposed language means that both approved prescription drugs and biologics would be in scope for the new legislation. The provisions of the proposed Act would not apply to over-the-counter, compounded, or unapproved prescription drugs, medical devices, dietary supplements, or cosmetics.
2. Who is “the holder of the approved application under section 505 or of the license under such section 351?”
This term means that the proposed legislation will explicitly apply only to new drug applicants and the biological license applicants, which are typically the manufacturers of these products. However, pharmaceutical manufacturers are not the only entities engaged in advertising of prescription drug products and biologics. Arguably, other entities such as wholesalers, pharmacies, and telemedicine companies that do not have contractual relationship with a drug or biologic manufacturer could advertise a prescription drug product or a biologic even if the Act is enacted. It remains open as to whether this ambiguous loophole will be addressed if the bill moves forward.
3. What is a “promotional communication targeting consumers” … “for purposes of marketing such a drug?”
Traditionally, prescription drug promotion includes the name of a drug product and at least one claim about the intended effects of the drug product and refers to promotion targeting consumers and health care professionals. DTC promotion specifically targets lay individuals who may be prescribed (or seek to be prescribed) a specific drug product. Currently, there are several different types of drug promotion. A reminder promotion is designed to increase product name recognition; it does not mention the drug’s uses or make any medical claims. Help-seeking promotion talks about a disease or medical condition, not a particular drug, and encourages consumers to see their doctor if they think they have the condition. A full product promotion describes a specific drug, including information about its uses, benefits, and risks. Under the proposed Act, drug product promotional communications of any kind by pharmaceutical manufacturers would arguably no longer be permitted.
What is the Impetus Behind the End Prescription Drug Ads Now Act?
The Act comes on the heels of an attempt earlier this year by Senators Dick Durbin (D-IL) and Roger Marshall (R-KS) to close perceived “legal loopholes” in the U.S. Food and Drug Administration’s (FDA) ability to enforce its regulations against false and misleading prescription drug promotions by social media influencers and telehealth companies, introduced by the Protecting Patients from Deceptive Drug Ads Act. Our blog “Telehealth Companies and Social Media Influencers May Face New FDA Laws” discusses that legislation.
In addition to the End Prescription Drug Ads Now Act, it has been reported that the White House is discussing policies to restrict DTC drug advertising. Secretary of Health & Human Services, Robert F. Kennedy, Jr., has raised concerns about the state of DTC drug advertising and has discussed goals to require more clear disclosures of adverse side effects within drug advertisements to better inform patients and prescribers of the risks. Secretary Kennedy has also discussed a proposal to remove the ability to deduct DTC drug advertising as a business expense for tax purposes. In each case, the proposed policies would result in prescription drug advertising being more expensive for manufacturers.
Pharmaceutical DTC advertising continues to be a sizeable way of promoting drugs to reach new consumers, with some analysis noting a return on investment for DTC drug ads “ranging as high as 100%-500%, depending on the drug.” In addition, judicial precedent has historically favored drug manufacturers with courts ruling that such advertising is protected under the First Amendment’s Constitutional guarantee of the right to free speech.
What to Expect Next?
It is unclear whether the Act will pass or to what extent the White House’s efforts to restrict drug advertising will be pursued. What is clear, however, is the growing bipartisan interest in banning or significantly curtailing DTC advertising of prescription drug products across all media platforms. Such a change would trigger a significant departure from current pharmaceutical practices and would bring the United States in line with the rest of the World; New Zealand is the only other country that currently allows DTC drug advertising.
Möchten Sie mehr erfahren?
Foley unterstützt Sie bei der Bewältigung der kurz- und langfristigen Auswirkungen von Gesetzesänderungen. Wir verfügen über die notwendigen Ressourcen, um Sie bei diesen und anderen wichtigen rechtlichen Überlegungen im Zusammenhang mit Geschäftsabläufen und branchenspezifischen Fragen zu unterstützen. Bitte wenden Sie sich an die Autoren, Ihren Foley-Ansprechpartner oder an unsere Praxisgruppe Gesundheitswesen und Sektor Gesundheitswesen & Biowissenschaften mit allen Fragen.
