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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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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Sept. 7, 2020 – A direct-to-consumer (DTC) television ad featuring an animated syringe yielded Xeris Pharmaceuticals Inc. an enforcement letter from the FDA’s Office of Prescription Drug Promotion (OPDP) for alleged violations related to the product’s risk profile that “create a misleading impression about its safety and effectiveness.” In an Aug. 14 Untitled Letter, OPDP […]
Read more Aug. 3, 2020 – The background music in direct-to-consumer (DTC) ads “is a distraction from the presentation of risks … and bombards the viewer with excess stimuli making it difficult for them to retain the information,” according to an Aug. 3 Citizen Petition sent to the Food and Drug Administration (FDA) by Knowledge Ecology International […]
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June 17, 2020 – The U.S. Court of Appeals for the D.C. Circuit yesterday affirmed the U.S. District Court for the District of Columbia opinion that set aside the Center for Medicare and Medicaid Services (CMS) rule calling for drug manufacturers to disclose drug list prices in direct-to-consumer television ads. In the June 16 opinion, […]
Read more Jan. 20, 2020 — A three-judge panel in the U.S. Court of Appeals for the District of Columbia sounded skeptical of the Trump administration’s position when it heard oral arguments last week in the government’s appeal of a U.S. District Court judge’s decision that struck down a Centers for Medicare & Medicaid Services (CMS) rule […]
Read more Dec. 9, 2019 – The Office of Prescription Drug Promotion’s (OPDP’s) proposed study of the increasingly-common direct-to-consumer (DTC) television advertising for oncology drugs seeks to examine how consumers parse the information they are receiving, but commenters on the proposal argue that some of the study’s parameters should be changed before moving forward. The proposed OPDP […]
Read more Nov. 18, 2019 – Amgen, Eli Lilly, Merck & Co. and the Association of National Advertisers (ANA) are once again striking back at the U.S. Department of Health and Human Services (HHS) effort to mandate drug prices in direct-to-consumer (DTC) television ads. Although the four entities sued HHS over its recent regulation calling for the […]
Read more Oct. 21, 2019 — What is next in the effort to require inclusion of list prices in direct-to-consumer (DTC) promotion of pharmaceuticals? A variety of scenarios were outlined by James Czaban, chair of the FDA Practice Group at DLA Piper in Washington, during a panel at last week’s Food and Drug Law Institute conference on […]
Read more Sept. 16, 2019 – Five research studies conducted by the FDA’s Office of Prescription Drug Promotion (OPDP) – four of which examine aspects of direct-to-consumer (DTC) advertising – are complete and awaiting peer review and publication, according to OPDP’s Website. “Taken together, the OPDP studies now nearing release will make an important contribution to the […]
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