Tag: Risk Information

Risk Information

Regulatory/FDA

OPDP Focuses on Misleading Opioid Claims Amid National Crisis

OPDP Focuses on Misleading Opioid Claims Amid National Crisis

Feb. 23, 2021 – Amid a surge in opioid overdose deaths over the past year – due in part to the ongoing COVID-19 pandemic and its corresponding isolation and lack of employment and support services – the FDA’s Office of Prescription Drug Promotion (OPDP) has asserted the agency’s “ongoing commitment to combat inappropriate opioid use.” […]

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Regulatory/FDA

Azurity Email Garners OPDP Enforcement Letter for False/Misleading Claims

Azurity Email Garners OPDP Enforcement Letter for False/Misleading Claims

Dec. 14, 2020 – In a recent Untitled Letter, the FDA’s Office of Prescription Drug Promotion (OPDP) states that claims made by Azurity Pharmaceuticals Inc. in a healthcare professional email for XATMEP® (methotrexate) oral solution indicate that Azurity “appears to be promoting Xatmep without presenting the serious risks of the drug in a truthful and […]

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Regulatory/FDA

OPDP Untitled Letter Cites False, Misleading Claims about Efficacy, Risk Presentation for Obesity Drug

OPDP Untitled Letter Cites False, Misleading Claims about Efficacy, Risk Presentation for Obesity Drug

June 19, 2019 – The FDA’s Office of Prescription Drug Promotion (OPDP) has cited VIVUS Inc. for making false or misleading claims about the efficacy of and risks associated with Qsymia capsules, which are intended to be an adjunct treatment for obesity with a reduced-calorie diet and increased exercise, but allegedly were promoted as being […]

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presentations of risk or efficacy information in direct-to-consumer (DTC) ads more consumer friendly, according to draft guidance issued by the FDA’s Office of Prescription Drug Promotion (OPDP). The draft guidance, “Presenting Quantitative Efficacy and Risk Information in [DTC] Promotional Labeling and Advertisements,” […]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

DTC Docket Draws Health Professional, Consumer Comments

DTC Docket Draws Health Professional, Consumer Comments

Nov. 17, 2017 — In response to an Office of Prescription Drug Promotion (OPDP) call for input on a “limited risks plus disclosure” strategy for broadcast direct-to-consumer (DTC) ads, the FDA received 39 comments from health professionals and consumers as of Nov. 16. Although several of the commenters call for a complete ban on DTC […]

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DTC Advertising

FDA Regulations on DTC Risk Information Could Be Backfiring

FDA Regulations on DTC Risk Information Could Be Backfiring

Oct. 16, 2017 — As the FDA considers the most effective way for pharmaceutical companies to present risks in direct-to-consumer (DTC) ads, a recently published paper in Nature Human Behavior underscores the commonly held belief that consumers do not respond well to a barrage of product risk information. According to the paper abstract, these long […]

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DTC Advertising

Limiting Risk Disclosures in DTC Ads Improves Recall of Risk, FDA Study Shows

Limiting Risk Disclosures in DTC Ads Improves Recall of Risk, FDA Study Shows

Aug. 11, 2017 – The results of a recent study conducted by the FDA and RTI International has concluded that a revised, briefer risk statement in broadcast direct-to-consumer (DTC) ads improves risk and benefit recognition and risk recall. As such, a move toward communicating a limited number of risks and including a disclosure alerting consumers […]

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DTC Advertising

OPDP to Conduct DTC Survey about Internet Access, Opening Risk Statements

OPDP to Conduct DTC Survey about Internet Access, Opening Risk Statements

June 20, 2017 – The FDA’s Office of Prescription Drug Promotion (OPDP) announced in the Federal Register last week that it would be conducting research on the ability and willingness of low- to non-Internet users to access direct-to-consumer (DTC) broadcast ad references to “adequate provision” of package labeling via a 1-800 number or print ad […]

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Risk Communication Advisory Committee to Discuss Communicating Uncertainty, Multiple Risks

June 26, 2012 – The FDA’s Risk Communication Advisory Committee is meeting Friday, June 29, to discuss recent research on communicating and understanding uncertainty, as well as risk perception in low-income populations with multiple risks. According to discussion topics for the meeting issued by the agency, the RCAC would like to get answers to the […]

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FDA Draft Guidance: Potentially a Significant Danger

The Coalition has developed an aggressive plan to address the FDA’s recent “draft guidance” for including risk information in advertising and other marketing materials. Under the leadership of Harry Sweeney, the Coalition has developed an aggressive plan to address the FDA’s recent “draft guidance” for presenting risk information in advertising and other marketing materials.

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