Tag: DTC advertising

DTC advertising

Regulatory/FDA

Current FDA Voluntary Pre-Publication Rx Ad Review Processes

Current FDA Voluntary Pre-Publication Rx Ad Review Processes

As run-up to FDA’s DTC Prescription Advertising Rule that goes into effect on May 20, 2024, CHC is working with FDA staff to help reinforce current ad review processes available to healthcare marketers and how review of ads will change in May and later this year with its November enforcement date. Watch for our planned […]

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Regulatory/FDA

FDA Issues Long-Awaited Final Rule for DTC Prescription Drug Ads

FDA Issues Long-Awaited Final Rule for DTC Prescription Drug Ads

The FDA’s final rule for Direct-to-Consumer Prescription Drug Advertisements (released on November 21, 2023) will certainly impact the creative decisions agencies will make about how to structure the agency refers to as the “major statement” or the dual modality of presenting in a balanced or “neutral” manner the drug’s benefits and risks in visually clear, […]

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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 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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DTC Advertising

“List Prices in DTC Ads” Proposal Reintroduced After Aduhelm Pricing Decision

“List Prices in DTC Ads” Proposal Reintroduced After Aduhelm Pricing Decision

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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DTC Advertising

Major Health Advertisers Inadvertently Placing Ads on Misinformation Sites

Major Health Advertisers Inadvertently Placing Ads on Misinformation Sites

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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DTC Advertising

OPDP Cites Xeris for Risk Presentation Issues in DTC TV Ad

OPDP Cites Xeris for Risk Presentation Issues in DTC TV Ad

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 […]

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DTC Advertising

Citizen Petition Says Music in DTC Ads Distracts from Risk Info, Calls for FDA Ban

Citizen Petition Says Music in DTC Ads Distracts from Risk Info, Calls for FDA Ban

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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Courts/First Amendment

D.C. Circuit Court Affirms Lower Court Ruling on Drug Price Disclosure Rule, Pulls No Punches

D.C. Circuit Court Affirms Lower Court Ruling on Drug Price Disclosure Rule, Pulls No Punches

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, […]

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DTC Advertising

Appeals Court Questions CMS Rule for DTC Ad List Prices

Appeals Court Questions CMS Rule for DTC Ad List Prices

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 […]

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