Tag: OPDP

OPDP

DTC Advertising

OPDP To Study Medication Adherence Claims

OPDP To Study Medication Adherence Claims

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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Regulatory/FDA

OPDP: Risk, Efficacy Claims for Cholesterol Drug in Doctor Promotion Are False/Misleading

OPDP: Risk, Efficacy Claims for Cholesterol Drug in Doctor Promotion Are False/Misleading

June 27, 2022 – False or misleading claims and representations in a professional promotion about the efficacy and risks of a prescription drug for high cholesterol are cited in a June 2 Untitled Letter from the Food and Drug Administration’s (FDA’s) Office of Prescription Drug Promotion (OPDP) to Althera Pharmaceuticals LLC. OPDP reviewed a “Doctor […]

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Regulatory/FDA

OPDP Reorg, Outreach Efforts Designed to Improve Relationship with Industry

OPDP Reorg, Outreach Efforts Designed to Improve Relationship with Industry

June 13, 2022 – From a staff reorganization to a monthly newsletter to increased collaborations with stakeholders, in 2022 the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) – under the direction of Dr. Catherine “Katie” Gray – has made a series of organizational and communications moves to make OPDP both more transparent […]

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Regulatory/FDA

OPDP to Study Risk/Benefit Tradeoff Decisions Made by Consumers, Physicians

OPDP to Study Risk/Benefit Tradeoff Decisions Made by Consumers, Physicians

May 31, 2022 – Understanding the tradeoffs among desirable and undesirable drug product characteristics that consumers and their treating physicians make “will provide valuable insight into the relevance and impact of various product attributes and promotional claims on informed choices and treatment decisions,” according to the Food and Drug Administration’s Office of Prescription Drug Promotion […]

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DTC Advertising

Presentation of Risks in DTC Video, HCP Webpage Yields Enforcement Letter for Bausch Health

Presentation of Risks in DTC Video, HCP Webpage Yields Enforcement Letter for Bausch Health

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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Regulatory/FDA

OPDP To Study DTC Website Promotion of Accelerated Approval Drugs

OPDP To Study DTC Website Promotion of Accelerated Approval Drugs

March 28, 2022 – As FDA Commissioner Robert Califf, M.D., determines how to fulfill his promise to re-examine the agency’s accelerated approval pathway and Congress continues to push for action, the FDA’s Office of Prescription Drug Promotion (OPDP) is tackling one piece of the puzzle: How well consumers understand the limitations of accelerated approval drugs […]

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Regulatory/FDA

Myers: FDA Priorities Persist Amid Challenges

Myers: FDA Priorities Persist Amid Challenges

Jan. 24, 2022 – With the COVID-19 pandemic heading into year three, the Food and Drug Administration (FDA) faces ongoing challenges but continues to work on four primary agency priorities, according to Nancy Bradish Myers, president of Catalyst Healthcare Consulting, who spoke at a Jan. 21 Coalition for Healthcare Communication webinar, “A New Start for […]

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Regulatory/FDA

Amgen Gets OPDP Untitled Letter for Claims about Neulasta Onpro vs. PFS Delivery

Amgen Gets OPDP Untitled Letter for Claims about Neulasta Onpro vs. PFS Delivery

July 26, 2021 – The FDA’s Office of Prescription Drug Promotion (OPDP) cited Amgen for making misleading claims that the delivery of its product Neulasta® through the Onpro® on-body injector is more effective than delivery through the pre-filled syringe (PFS) or is more effective than FDA-licensed biosimilars, which are only available through PFS. OPDP takes […]

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DTC Advertising

OPDP Will Study Accelerated Approval Product Disclosures to Gauge Consumer Understanding

OPDP Will Study Accelerated Approval Product Disclosures to Gauge Consumer Understanding

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 […]

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DTC Advertising

OPDP to Study DTC Multiple Indication Ads, Completes Three Studies in 2020

OPDP to Study DTC Multiple Indication Ads, Completes Three Studies in 2020

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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