Warning Letter

The FDA issues its second enforcement letter of 2017

The FDA issues its second enforcement letter of 2017

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The OPDP has only issued two letters in 2017, compared to 11 last year.

Five things for pharma marketers to know: Wednesday, September 6, 2017

Five things for pharma marketers to know: Wednesday, September 6, 2017

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The FDA warns drugmaker over opioid promotion; Watson may not be living up to the hype; Merck acquires immuno-oncology biotech

Five things for pharma marketers to know: Monday, August 28, 2017

Five things for pharma marketers to know: Monday, August 28, 2017

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Gilead to acquire Kite; the FDA issues fewest number of warning letters since 2008; the regulator approves BI's Humira biosimilar

The FDA cites risk info in letter over Contrave DTC ad

The FDA cites risk info in letter over Contrave DTC ad

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The regulator also took issue with how Orexigen Therapeutics presented the risk information

Five things for pharma marketers to know: Wednesday, April 26, 2017

Five things for pharma marketers to know: Wednesday, April 26, 2017

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GSK warns Advair generic competition may affect business in 2017; Lilly plans to meet FDA about baricitinib; FDA warns companies selling 'illegal' products

A Reformed FDA Under Trump Likely Means Uncertainty

A Reformed FDA Under Trump Likely Means Uncertainty

It's hard to be against the concept of reform, but Trump is better known for epithets than policy details, Kamp writes.

The FDA targeted DTC, video, unapproved drug promotion in 2016

The FDA targeted DTC, video, unapproved drug promotion in 2016

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The agency issued 11 enforcement letters last year.

MM&M staff predictions: From drug pricing to big data

MM&M staff predictions: From drug pricing to big data

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Our editorial staff contemplates what 2017 has in store for healthcare marketers, and we forsee big changes and some setbacks in the ongoing shift toward a data-driven, value-based industry.

Five things for pharma marketers to know: Tuesday, December 20, 2016

Five things for pharma marketers to know: Tuesday, December 20, 2016

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Biogen names new CEO; the FDA issues two warning letters; Allergan to acquire aesthetics firm

Warning letters most often stem from missing risk information

Warning letters most often stem from missing risk information

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The number of warning and untitled letters has dropped in recent years. Only four letters have been sent so far this year, compared to 28 in 2012.

Five things for pharma marketers to know: Friday, September 30, 2016

Five things for pharma marketers to know: Friday, September 30, 2016

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Vertex drug challenged by low refill rates; the FDA has issued only 4 warning or untitled letters this year; Horizon settles PBM-rebate suit

The FDA issues warning letter to Shionogi over co-pay voucher

The FDA issues warning letter to Shionogi over co-pay voucher

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The drugmaker marketed a co-pay assistance voucher that failed to provide any risk information about its drug Ulesfia.

2016 May Bring More Warning Letters, Guidance from FDA

2016 May Bring More Warning Letters, Guidance from FDA

It is worth noting that the FDA sent only nine warning letters last year, all focused on well-recognized violations, such as minimization of risk information and unsubstantiated claims.

The FDA settles with Pacira, rescinds warning letter

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The FDA withdrew a 2014 warning letter related to Pacira Pharmaceuticals' marketing of its painkiller Exparel as part of a settlement reached by both parties this week.

Omitting risk info in ads is top reason for FDA warning

Omitting risk info in ads is top reason for FDA warning

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An analysis conducted by J&J executives found that 58% of FDA warning letters and untitled letters over the last two years omitted risk information.

Five things for pharma marketers to know: Thursday, June 11

Five things for pharma marketers to know: Thursday, June 11

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Amgen's PCSK9 inhibitor is the second in its class to get an FDA panel endorsement; a new drug could threaten Shire's hold on a rare-disease category; a study shows pharma invests less in Hispanic audiences than in other groups

Five things for pharma marketers to know: Tuesday, June 2

Five things for pharma marketers to know: Tuesday, June 2

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A House committee is looking into the FDA's warning letter publication process; Amgen and Roche collaborate on cancer combination drug; study shows online health information fails teenagers

Five things for pharma marketers to know: Wednesday, January 21

Five things for pharma marketers to know: Wednesday, January 21

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President Barack Obama says personalized medicines need financial support in SOTU Address; Salix explores M&A options; lobbying groups PhRMA and BIO say generic painkillers without abuse-deterrent features should be pulled from shelves.

OPDP slams print ad in Untitled Letter

OPDP slams print ad in Untitled Letter

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The FDA's prescription drug promotion arm wrote that the professional print ad for seizure med Aptiom "misleadingly overstated its efficacy."

Pacira gets OPDP opioid promotion Warning Letter

Pacira gets OPDP opioid promotion Warning Letter

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The FDA's Office of Prescription Drug Promotion says Pacira's promotional materials for Exparel are "extremely concerning," but the drugmaker tells investors the fuss is probably because opioids have been getting a lot of attention lately.

FYI: FDA habla español

The FDA issued a Warning Letter over unapproved drug claims published in Spanish.

Vet drugmakers get Warning Letters too

Regulatory Focus reports that the regulator has issued a Warning Letter to AB Science for marketing its canine tumor drug Kinavet for unapproved, off-label uses.

"Likes" put Zarbee's in FDA crosshairs

"Likes" put Zarbee's in FDA crosshairs

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The FDA says the OTC remedy maker's online behavior—including Liking customer Facebook posts—has put the company's drugs in unapproved drug territory.

EMA publishes noncompliance letters

The European Medicines Agency makes its equivalent of FDA manufacturing warning letters public.

FDA slams 23andMe over genetic testing device

FDA slams 23andMe over genetic testing device

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Regulators say the company has not received approval for the device's touted functions.

Researcher finds black-box drugs have high Warning Letter risk

EyeonFDA finds that, when it comes to black-boxed drugs' marketing materials, the FDA is more likely to issue Warning Letters than untitled letters.

Merz web-copy shortcuts don't sit well with OPDP

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FDA's Office of Prescription Drug Promotion issued an Untitled Letter over what it says are misleading copy and overstated efficacy claims online.

Business briefs: GlaxoSmithKline and Spectrum

GSK sees a regulatory setback on its once-weekly GLP-1 med, and Spectrum Pharma gets hit with an untitled letter from OPDP on a sales aid for Zevalin.

OPDP sends Warning Letter to Acorda

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The ad watchdog flagged the drug maker for what it said was yet another misleading Ampyra promotional piece.

Business briefs: Teva, AbbVie, Novartis, Wockhardt

FDA grants Teva three years exclusivity to sell Plan B OTC for all ages; FDA gives Humira a thumbs-down for spondyloarthritis; a UK vaccine committee rejects Novartis' meningitis B shot; and Wockhardt gets a warning letter from FDA for its manufacturing practices at an Indian plant.