The FDA’s final rule for Direct-to-Consumer Prescription Drug Advertisements (released on November 21, 2023) will certainly impact the creative decisions agencies will make about how to structure the agency refers to as the “major statement” or the dual modality of presenting in a balanced or “neutral” manner the drug’s benefits and risks in visually clear, […]
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On May 9, 2023, the Maryland Supreme Court reversed a ruling by the Anne Arundel Circuit Court that Maryland’s tax on digital advertising was unconstitutional, saying the court lacked jurisdiction over the case. In an order, Chief Justice Matthew Fader punted the case back to the Anne Arundel County Circuit Court and ordered it to dismiss the case […]
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Oct. 4, 2022 – How physicians and patients view medication adherence claims in online ads is the subject of a two-part research study announced recently by the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP). “Patient non-adherence to medication regimes is a well-known challenge in health care,” OPDP stated in the Sept. 23 […]
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April 18, 2022 – A recent enforcement letter from the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) to Bausch Health Companies Inc. takes issue not only with omission of risk information in a direct-to-consumer (DTC) video and a webpage of a healthcare professional website, but also with a lack of balance […]
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Jan. 31. 2022 – Presenting drug benefit information without also including risk information in a social media post on Instagram misbrands Eli Lilly’s Trulicity® according to a recent enforcement letter to the company from the FDA’s Office of Prescription Drug Promotion (OPDP). In the Jan. 19 Untitled Letter, OPDP states that it reviewed the post […]
Read more Jan. 17, 2022 – A common theme among the enforcement letters issued by the FDA’s Office of Prescription Drug Promotion (OPDP) is the manner in which a drug’s promotional materials present product benefits while omitting product risk information. In its final Untitled Letter of 2021 to Eli Lilly, OPDP repeated this message, but the company’s […]
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June 29, 2021 – In the wake of the FDA granting a controversial accelerated approval for Biogen’s aducanumab (Aduhelm) – and Biogen’s decision to set the list price for the drug for Alzheimer’s disease at $56,000 per year despite equivocal evidence of efficacy – members of Congress are introducing drug pricing legislation, calling for hearings, […]
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June 21, 2021 – Amid increased scrutiny of its accelerated approval pathway – partly prompted by the recently rescinded approval for two oncology product indications and the controversial approval of Biogen’s aducanamab for Alzheimer’s disease – the FDA’s Office of Prescription Drug Promotion (OPDP) has announced plans to study how well consumers understand the limitations […]
Read more May 24, 2021 – The FDA’s Office of Prescription Drug Promotion (OPDP) is preparing to study whether consumers are challenged when multiple indications for the same drug are promoted in a single television ad. “It is our hypothesis that participants will be more likely to correctly recall and understand the first indication when it is […]
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March 8, 2021 – Pharmaceutical companies and other healthcare stakeholders who utilize programmatic advertising are unintentionally placing ads that promote COVID-19 vaccines, vaccine distribution and safe pandemic practices on websites that are spreading false health information, according to a recent report from Newsguard. “Throughout the pandemic, many of the world’s largest and most trusted brands […]
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