Tag: DTC advertising

DTC advertising

Washington Focus

Sen. Coons Opposes Compelling List Prices in DTC Ads

Sen. Coons Opposes Compelling List Prices in DTC Ads

Nov. 28, 2018 — When it comes to healthcare in the United States, “we’ve got a lot of work to do in promoting transparency, bringing down cost, and making sure we are tying reimbursement to value of care rather than quantity of care,” Sen. Chris Coons (D-Del.) told attendees of the Coalition for Healthcare Communication’s […]

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DTC Advertising

NEJM: Drug Price Information in DTC Ads Raises Public Health, Legal Concerns

NEJM: Drug Price Information in DTC Ads Raises Public Health, Legal Concerns

Nov. 19, 2018 – In a featured “Perspective” article in The New England Journal of Medicine (NEJM) this week, Stacie B. Dusetzina, Ph.D., and Michelle M. Mello, J.D., Ph.D., state that although providing cost information about prescription drugs is valuable, mandating that companies use the wholesale acquisition cost (WAC) in direct-to-consumer (DTC) ads “raises substantial […]

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Regulatory/FDA

Three New OPDP Research Studies to Cover Broad Array of Promotional Activities

Three New OPDP Research Studies to Cover Broad Array of Promotional Activities

Oct. 22, 2018 – Broadcast disease awareness ads, accelerated approval disclosures in direct-to-consumer (DTC) ads, and physician interpretation of drug information in scientific publications as compared to promotional pieces are the subjects of future Office of Prescription Drug Promotion (OPDP) research, according to notices published Oct. 17 in the Federal Register. “All three of these […]

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DTC Advertising

OPDP Guidance on Presenting Risk, Efficacy Info in DTC Ads Calls for Consumer-friendly Approaches

OPDP Guidance on Presenting Risk, Efficacy Info in DTC Ads Calls for Consumer-friendly Approaches

Oct. 19, 2018 – It is important for drug companies to make quantitative presentations of risk or efficacy information in direct-to-consumer (DTC) ads more consumer friendly, according to draft guidance issued by the FDA’s Office of Prescription Drug Promotion (OPDP). The draft guidance, “Presenting Quantitative Efficacy and Risk Information in [DTC] Promotional Labeling and Advertisements,” […]

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DTC Advertising

HHS’ Azar Announces Proposed Rule Requiring DTC Ad Price Disclosures

HHS’ Azar Announces Proposed Rule Requiring DTC Ad Price Disclosures

Oct. 16, 2018 – Yesterday morning, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced a program under which member companies would refer patients to online information about medicine costs in direct-to-consumer (DTC) ads. But then yesterday afternoon, Department of Health and Human Services (HHS) Secretary Alex Azar made clear that this effort would not […]

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DTC Advertising

Amendment to Fund Drug Prices in Ads Dropped to Avert Derailment of HHS Spending Bill

Amendment to Fund Drug Prices in Ads Dropped to Avert Derailment of HHS Spending Bill

Sept. 24, 2018 — With the amendment to fund the implementation of mandatory drug prices in consumer advertising stripped out of the spending bill to which it had been attached, the question of whether or how quickly this drug pricing mandate will move forward remains unclear. The amendment, from Sens. Dick Durbin (D-Ill.) and Charles […]

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DTC Advertising

Mandated Drug Pricing Disclosures in DTC Ads Loom Large

Mandated Drug Pricing Disclosures in DTC Ads Loom Large

Sept. 10, 2018 – Movement toward mandating that drug companies include product prices in consumer-directed ads continues this fall as Congress and the Trump administration push for greater transparency in drug pricing. On Aug. 23, the Senate voted to include an amendment sponsored by Sens. Dick Durbin (D-Ill.) and Chuck Grassley (R-Iowa) to a spending […]

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DTC Advertising

Senate and HHS Make Moves to Advance Mandatory Drug Prices in Consumer Ads

Senate and HHS Make Moves to Advance Mandatory Drug Prices in Consumer Ads

Aug. 24, 2018 – Yesterday was a one-two punch in the Trump administration’s effort to move forward a plan to require that drug manufacturers include drug prices in ads directed toward consumers, as the White House Office of Management and Budget (OMB) reviews a proposed rule from the Department of Health & Human Services (HHS) […]

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Regulatory/FDA

FDA Studying Extent of Risk Information in DTC Print Ads

FDA Studying Extent of Risk Information in DTC Print Ads

Aug. 20, 2018 – The FDA continues to consider whether the amount and location of risk disclosure information currently appearing in direct-to-consumer (DTC) print ads – both in the brief summary and the “important safety information” (ISI) section – has the potential to “overwarn” consumers. In an FDA notice in the Federal Register last week, […]

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Legislative

House Appropriations Bill Does Not Include Authorization of Mandatory Drug Prices in Ads

House Appropriations Bill Does Not Include Authorization of Mandatory Drug Prices in Ads

July 13, 2018 – On the “no news is good news” front, the House Appropriations Committee voted this week on next year’s funding level for the U.S. Department of Health and Human Services (HHS) without taking up an amendment to give HHS and FDA explicit authority to mandate drug list prices in consumer advertising. “What […]

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