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 […]
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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 […]
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 […]
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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 July 9, 2019 – One day before the Centers for Medicare & Medicaid Services’ (CMS’) final rule requiring drug companies to disclose the wholesale acquisition cost (WAC) or “list price” of their drugs in television ads was due to go into effect, the U.S. District Court for the District of Columbia issued a memorandum opinion […]
Read more June 17, 2019 – The Trump administration’s final rule mandating that drug companies include the wholesale acquisition cost (WAC) in direct-to-consumer (DTC) television ads for many drugs “exceeds [the Department of Health and Human Services’ (HHS’)] statutory authority, violates the First Amendment, and should therefore be set aside,” according to a lawsuit filed Friday, less […]
Read more April 8, 2019 – The first television ads including drug price information are hitting the airwaves, reinforcing the point that list price is a highly misleading metric, and Pharmaceutical Research and Manufacturers of America (PhRMA) members are preparing to voluntarily refer consumers to online drug pricing information in their drug ads within a few weeks. […]
Read more Feb. 11, 2019 – Last week Johnson & Johnson announced that it would include both the list price of a drug and information about what patients realistically might expect to pay out of pocket for its drugs in direct-to-consumer (DTC) ads by the end of the first quarter, starting with Xarelto, its most-prescribed medication. This […]
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Jan. 15, 2019 – In comments to the Centers for Medicare and Medicaid Services (CMS) regarding its proposal to require that drug companies include the wholesale acquisition cost (WAC) of a drug in direct-to-consumer (DTC) television ads, industry trade groups and pharmaceutical companies largely are in agreement that doing so would confuse consumers, that CMS […]
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Aug. 22, 2017 – In the wake of an FDA study showing that consumers recall risk information better when they are not inundated with a comprehensive list of risks in direct-to-consumer (DTC) ads, the agency is establishing a public docket “to assist with its development of recommendations” in this area. The FDA’s Office of Prescription […]
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