Search Results for OPDP

Showing 1 – 25  of 53

OPDP Issues Third Warning of 2017 By Zachary Brennan - Published 28 November 2017

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) this month issued its third warning or untitled letter of the year to Kentucky-based Magna Pharmaceuticals because its webpage and panels from a conference exhibit made false or misleading claims about the risks associated with and efficacy of its insomnia treatment Zolpimist (zolpidem tartrate).

Categories: News, US, FDA, Advertising and Promotion, Compliance, Drugs, Government affairs

Tags: untitled letter, warning letter, OPDP

FDA Enforcement Trends for Broadcast Advertisements By Justin Mann, Julie Tibbets - Published 28 September 2017

This article presents recent FDA enforcement trends related to broadcast advertisements and explains how regulatory professionals can approach the review and approval of promotional materials. The article also provides a review of relevant FDA authorities and guidance, as well as practical takeaways for industry with a focus on product ads appearing on TV or YouTube that may distract viewers from important risk information.

Categories: Features, US, FDA, Advertising and Promotion, Drugs

Tags: Office of Prescription Drug Promotion, OPDP, Warning Letter, YouTube, Social Media

FDA Warns Drugmaker Over Opioid Marketing Materials By Michael Mezher - Published 05 September 2017

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) has warned Canadian drugmaker Cipher Pharmaceuticals over promotional materials for its combination immediate and extended release opioid ConZip (tramadol hydrochloride).

Categories: News, US, FDA, Advertising and Promotion, Drugs

Tags: ConZip, OPDP, Warning Letter, Office of Prescription Drug Promotion

OPDP Study Raises Questions About the Balance of Information in Mobile Ads By Michael Mezher - Published 05 July 2017

A new study by officials from the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) raises questions about the balance of benefit and risk information in mobile ads for prescription drugs.

Categories: News, US, FDA, Advertising and Promotion, Communication, Prescription drugs

Tags: OPDP, Office of Prescription Drug Promotion, Mobile Ads

FDA Cracks Down on TV Ad for Prescription Weight Loss Drug By Zachary Brennan - Published 24 May 2017

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) sent its first untitled letter of 2017 to Orexigen Therapeutics for a television ad that created a misleading impression about the safety of the weight loss drug Contrave (naltrexone HCl and bupropion HCl).

Categories: News, US, FDA, Advertising and Promotion, Drugs, Government affairs

Tags: OPDP, Contrave, untitled letter, drug advertisements, TV drug ads

FDA Discusses Upcoming Proposed Rule on One-Page Patient Medication Information By Zachary Brennan - Published 23 February 2017

Officials from the US Food and Drug Administration (FDA) gathered on Thursday at DIA's advertising and promotion conference in Washington, DC, to discuss recent research, guidance for industry and enforcement action on pharmaceutical and medical device advertising and promotion.

Categories: News, US, FDA, Advertising and Promotion

Tags: OPDP, Patient Medication Information, proposed rule

FDA’s OPDP Issues 5th Warning of 2016, Calls out Video’s Misleading Comments By Zachary Brennan - Published 04 November 2016

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) earlier this week sent a letter to Rockville, MD-based Supernus Pharmaceuticals noting that one of its promotional videos makes false or misleading claims and/or representations about the risks associated with Oxtellar XR (oxcarbazepine).

Categories: News, US, FDA, Advertising and Promotion, Drugs, Regulatory intelligence, Regulatory strategy

Tags: OPDP, untitled letter, FDA warning for advertising

Promotional Materials at ASCO Land Jazz Subsidiary FDA's Third Untitled Letter of 2016 By Zachary Brennan - Published 06 September 2016

In just its third untitled letter of the year (and the first in almost five months), the US Food and Drug Administration (FDA) on Tuesday called out Jazz Pharmaceuticals subsidiary Celator Pharmaceuticals for promoting an investigational drug in a panel at the American Society of Clinical Oncology’s (ASCO) annual meeting in June.

Categories: News, US, FDA, Biologics and biotechnology, Crisis management, Drugs, Due Diligence, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: ASCO, Jazz Pharmaceuticals, OPDP, untitled letter

OPDP Untitled Letter Takes Issue With Shionogi's Copay Assistance Voucher By Zachary Brennan - Published 04 April 2016

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) has found that Shionogi’s “Patient Co-Pay Assistance Voucher” for Ulesfia (benzyl alcohol) lotion to help treat head lice is false or misleading because it omits important risk information.

Categories: News, US, FDA, Advertising and Promotion, Crisis management, Drugs, Labeling

Tags: OPDP untitled letter, pharmaceutical marketing violations, Ulesfia, Shionogi

Updated: Pfizer Receives FDA Untitled Letter Over YouTube Video By Zachary Brennan - Published 20 January 2016

The US Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Pfizer subsidiary Hospira over the company's "misleading" YouTube video on its sedative Precedex. [Editor's note: This story was updated on 21 January with a Pfizer statement on the video.]

Categories: News, US, FDA, Advertising and Promotion, Crisis management, Drugs

Tags: Pfizer, Precedex, Hospira, untitled letters, OPDP

FDA Promotional Enforcement Actions Hit Record Low in 2015 By Michael Mezher - Published 19 January 2016

The US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) issued a record-low nine letters to companies for advertising and promotion violations.

Categories: News, US, FDA, Advertising and Promotion, Communication, Prescription drugs

Tags: Office of Prescription Drug Promotion, OPDP, Warning Letter

Walking the Digital Tight-Rope By Linda Pollitz, Moulakshi Roychowdhury, PharmD, JD - Published 05 November 2015

On behalf of the Regulatory Focus Board of Editors, we would like to introduce you to a collection of articles on the regulatory oversight of advertising, labeling and social media.

Categories: Under RAPS, China, US, FDA, Advertising and Promotion, Communication, Drugs

Tags: Social media guidance, Office of Prescription Drug Promotion, OPDP, Regulatory Focus

Correlation Between OPDP Untitled or Warning Letters and OIG Settlements or Corporate Integrity Agreements with Sponsors By Betsy Kurian, PharmD, Moulakshi Roychowdhury, PharmD, JD - Published 09 October 2015

This article discusses the existence of a correlation between OPDP enforcement letters and OIG settlements or corporate integrity agreements with pharmaceutical companies.

Categories: Features, US, FDA, Advertising and Promotion, Compliance, Prescription drugs, Government affairs

Tags: Office of Prescription Drug Promotion, OPDP, Office of Inspector General, (OIG), Untitled letters, Warning letters

Celebrity Endorsements—Lights, Camera, Enforcement Action? By Georgina Lee, PharmD - Published 23 September 2015

This article discusses the use of celebrity endorsements to promote a disease state or a pharmaceutical drug.  

Categories: Features, US, FDA, Advertising and Promotion, Drugs, Due Diligence, Ethics, Regulatory intelligence, Regulatory strategy

Tags: Kim Kardashian, OPDP, warning letter, drug advertising, DTCA, Samuel L. Jackson

FDA Making Changes to its Drug Advertising Review Process By Alexander Gaffney, RAC - Published 22 April 2015

A new guidance document finalized by the US Food and Drug Administration (FDA) proposes to make it easier for pharmaceutical marketing professionals to submit their advertisements and promotional materials for review by regulators.

Categories: News, US, CDER, Advertising and Promotion

Tags: Form FDA 2253, OPDP, Promotion, Advertising, Promotional Materials, Guidance, Draft Guidance

Do Price Comparisons Affect How Safe Patients Think a Drug is? FDA Plans to Find Out By Alexander Gaffney, RAC - Published 03 April 2015

The US Food and Drug Administration (FDA) plans to study whether including pricing information on the label of a pharmaceutical product affects how consumers view the safety and efficacy of drug products, especially when comparisons are made between two drugs.

Categories: News, US, CDER, Advertising and Promotion, Biologics and biotechnology, Drugs, Labeling

Tags: Drug Advertising, Pharmaceutical Advertising, OPDP, Office of Prescription Drug Promotion, Price Comparisons in Drug Advertising

FDA Ad Regulators Cite UCLA Over Development Partner's Website By Alexander Gaffney, RAC - Published 06 March 2015

The US regulator of pharmaceutical advertising, the US Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP), has issued a new warning to the University of California for allegedly promoting an investigational new drug for conditions for which it had not obtained approval.

Categories: News, US, CDER, Advertising and Promotion, Drugs

Tags: Untitled Letter, OPDP, Misbranded

FDA's Advertising Regulators Cite Drug Company in First Warning of 2015 By Alexander Gaffney, RAC - Published 11 February 2015

For the first time this year, the US Food and Drug Administration's (FDA) pharmaceutical advertising watchdog, the Office of Prescription Drug Promotion (OPDP), has issued a warning to a company for allegedly trying to promote a product for uses for which it had not received FDA approval.

Categories: News, US, CDER, Advertising and Promotion, Drugs, Labeling

Tags: OPDP, Office of Prescription Drug Promotion

FDA Calls for Changes to Drug Advertising in Hopes of Increasing Patient Understanding By Alexander Gaffney, RAC - Published 06 February 2015

The pharmaceutical advertising you see in magazines and newspapers will soon include less information in the hopes of better conveying what the actual risk of the drug is, the US Food and Drug Administration (FDA) announced today.

Categories: News, US, CDER, Advertising and Promotion, Biologics and biotechnology, Drugs, Labeling

Tags: DTC Advertising, FDA Regulation of Advertising, Pharmaceutical Advertising, Drug Advertising, Guidance, Draft Guidance, OPDP

FDA Plans Huge Study on How Public Understands Drug Risk By Alexander Gaffney, RAC - Published 19 November 2014

Categories: News, US, CDER, Advertising and Promotion, Biologics and biotechnology, Drugs

Tags: OPDP, Study, Advertising, Drug Risk, Drug Benefit

Does Your Spouse Affect How you Perceive Drug Safety? An FDA Study Aims to Find out By Alexander Gaffney, RAC - Published 13 November 2014

The US Food and Drug Administration (FDA) has announced another proposed study of consumers who watch drug advertising on TV—the second this week—this time trying to assess how spouses influence how consumers understand a drug's benefits and risks.

Categories: News, US, CDER, Advertising and Promotion, Drugs

Tags: DTC Advertising, OPDP, Study, Drug Advertising, Spouse

In Unusual Letter, FDA Dismantles Company's Drug Superiority Claims By Alexander Gaffney, RAC - Published 06 November 2014

The US Food and Drug Administration's (FDA) drug advertising oversight division has sent a warning to a pharmaceutical company regarding materials used to promote a drug, saying the materials omitted "important risk information" and contained claims about the drug's superiority that did not hold up to the agency's close scrutiny.

Categories: News, US, CDER, Advertising and Promotion, Drugs

Tags: Untitled Letter, OPDP, Unsubstantiated Claims, Risk Information, Office of Prescription Drug Promotion

FDA Sends Warning Letter Over Anesthesia Drug's Claims, but Company Defends Ads By Alexander Gaffney, RAC - Published 25 September 2014

New Jersey-based pharmaceutical manufacturer Pacira Pharmaceuticals has been sent a Warning Letter by the US Food and Drug Administration (FDA) after the regulator took issue with the way in which the company was promoting its analgesic drug Exparel.

Categories: News, US, CDER, Compliance, Drugs, Labeling

Tags: Warning Letter, Pacira, Exparel, OPDP, Advertising, Promotion

Implied Claims of Superiority Lead to Untitled Letter for Pharma Company By Alexander Gaffney, RAC - Published 19 September 2014

The US Food and Drug Administration (FDA) has sent a warning to Cipher Pharmaceuticals over an email marketing piece sent by the company to promote its cholesterol drug Lipofen, saying the piece over-stated the drug's effectiveness.

Categories: News, US, CDER, Drugs, Labeling

Tags: OPDP, Untitled Letter, Misbranding, Superiority

Comparative Claims in Advertising Make Drugs Seem Safer, More Effective By Alexander Gaffney, RAC - Published 11 September 2014

Using comparative claims in drug advertisements can make them more effective at persuading consumers that a drug is safer and more effective than the drug it’s being compared to, according to new research conducted by the US Food and Drug Administration (FDA) and published this month.

Categories: News, US, CDER, Biologics and biotechnology, Drugs, Labeling

Tags: OPDP, Study, Advertising, Promotion, Comparative Claims