Tag: bad ad program

bad ad program

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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Regulatory/FDA

Two Recent OPDP Letters Prompted by “Bad Ad Program” Complaints

Two Recent OPDP Letters Prompted by “Bad Ad Program” Complaints

March 15, 2021 – The FDA Office of Prescription Drug Promotion (OPDP) marked the 10-year anniversary of the Bad Ad Program in 2020, and kicks off 2021 with three enforcement actions – two Warning Letters and one Untitled Letter – two of which cited the Bad Ad Program as the source of complaints about potentially […]

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Regulatory/FDA

Bad Ad Complaints Yield Two OPDP Warning Letters, One on COVID Email Claims

Bad Ad Complaints Yield Two OPDP Warning Letters, One on COVID Email Claims

Oct. 12, 2020 – The FDA’s Office of Prescription Drug Promotion (OPDP) enforcement efforts are picking up steam following a slow start – just one enforcement letter issued between January 2020 and July 2020 – with two recent Warning Letters resulting from complaints through the agency’s Bad Ad Program. In a Sept. 22 Warning Letter […]

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Regulatory/FDA

FDA To Study Consumer, HCP Ability to Spot Deceptive Drug Ads

FDA To Study Consumer, HCP Ability to Spot Deceptive Drug Ads

Dec. 22, 2017 — The FDA recently announced that it was planning to study whether consumers and healthcare professionals have the ability to “spot and report” deceptive prescription drug promotion practices (https://www.gpo.gov/fdsys/pkg/FR-2017-12-12/pdf/2017-26704.pdf). The FDA’s Office of Prescription Drug Promotion (OPDP), which issued the lowest number of enforcement letters ever in 2017, appears to be looking […]

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Regulatory/FDA

FDA Will Study Consumer and HCP Ability to Identify Deceptive Drug Promotion

FDA Will Study Consumer and HCP Ability to Identify Deceptive Drug Promotion

Jan. 4, 2017 – The FDA will examine whether consumers and health care professionals (HCPs) can identify deceptive claims in prescription drug promotion, according to a notice published in today’s Federal Register. Results of the study could lead to an expansion of the FDA’s Bad Ad program to include consumer reporters. Although empirical research has […]

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OPDP to Industry: Voluntary Compliance Efforts in New Year Can Prevent Same Old Violations

Jan. 6, 2011 – As the pharmaceutical industry begins 2012, the FDA’s Office of Prescription Drug Promotion (OPDP) recommends that companies focus their efforts on many of the common problem areas faced by their competitors in the last quarter of 2011, according to OPDP Regulatory Counsel Julie Chronis. When asked by the Coalition for Healthcare […]

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FDA Launches Bad Ad Program

Read about it then comment here on our site. The FDA launched a new program Tuesday to educate healthcare providers about their role in ensuring that prescription drug advertising and promotion is truthful and not misleading. And the agency gave the outreach canadian phamacy effort an apt name: The Bad Ad Program. online jobs from […]

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