OPDP

Banner triggers OPDP letter to Oak Pharmaceuticals

The FDA's bad-ad group said the banner they saw at a professional conference was misleading.

Five things for pharma marketers to know: Wednesday, April 1

Five things for pharma marketers to know: Wednesday, April 1

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Takeda proposes $2.2-billion settlement to resolve Actos suits; Public Citizen says diabetes drugs are unlawfully promoted; PAIN study says 20% to 30% of opioid drugs are misused

FDA letter focuses on UCLA claims about an unapproved diagnostic

The agency's Office of Prescription Drug Promotion said a website indicated safety and effectiveness of a diagnostic tool that has not been approved by the FDA.

Five things for pharma marketers to know: Tuesday, March 10

Five things for pharma marketers to know: Tuesday, March 10

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HCV drugs and other specialty medications drove a 13% increase in last year's prescription spending, the CBO overestimated just how much healthcare reform would cost, and an FDA panel voted 17-0 in favor of Kythera's drug that can reduce double chins.

OPDP finds many flaws with Luitpold video

OPDP finds many flaws with Luitpold video

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The list of objections by the Office of Prescription Drug Promotion, which oversees medical advertising, is a familiar one, and includes concerns such as claims that go beyond the approved indication.

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.

OPDP says phentermine site thin on details

OPDP says phentermine site thin on details

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The bad-ad watchdog says the promotional website for the weight-loss medication Suprenza leaves out too much information.

OPDP takes on sales aid for alcohol drug

OPDP takes on sales aid for alcohol drug

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The advertising watchdog gave drugmaker Alvogen 15 days to make amends.

DOJ may cost Aegerion patients

The drugmaker's annual report indicates the company is concerned that an investigation into its marketing could dissuade doctors from prescribing Juxtapid.

FDA eases rules on ads in social media

FDA eases rules on ads in social media

The draft guidance is mostly procedural, and more guidance is expected, but experts say it does include some long-awaited clarity for advertisers.

Dept. of Justice subpoenas Aegerion

Dept. of Justice subpoenas Aegerion

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The drugmaker announced Friday that the DOJ wants documents regarding sales and marketing of Juxtapid, its drug for an ultra-rare lipid disorder.

OPDP not happy with Diclegis promo

OPDP not happy with Diclegis promo

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The bad-ad watchdog issued an untitled letter to drugmaker Duchesnay in November.

Aranesp mailer catches OPDP's attention

Aranesp mailer catches OPDP's attention

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The marketing watchdog's untitled letter says a direct mailer failed to disclose "material facts" from the warnings and precautions section of the PI.

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.

OPDP letter dings Kadmon for previous violation

OPDP letter dings Kadmon for previous violation

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The agency's bad-ad warning letter calls the new violations "particularly troubling."

TV interviews trigger Aegerion warning letter

TV interviews trigger Aegerion warning letter

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The FDA's Bad Ad group says the drugmaker misbranded its cholesterol drug during interviews on CNBC.

OPDP expands "Bad Ad" with CME

OPDP expands "Bad Ad" with CME

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The agency made good on a pledge to expand Bad Ad with a web-based CME course and case studies representing common problems.

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.

Pharma digerati launch advisory firm

Pharma digerati launch advisory firm

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The duo whose nonprofit served as neutral ground for getting FDA and industry talking about digital marketing is starting a for-profit research and advisory firm.

Pharma digerati launch advisory firm

Pharma digerati launch advisory firm

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The duo whose nonprofit served as neutral ground for getting FDA and industry talking about digital marketing is starting a for-profit research and advisory firm.

I'll take DTC for $10 million, Alex

I'll take DTC for $10 million, Alex

The Wizards of White Oak are spending $10 million on DTC ad research. Is this a wise use of sparse agency resources?

Xarelto print ad puts Janssen in hot water

Xarelto print ad puts Janssen in hot water

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The bad-ad group has hit the drug maker with an untitled letter, saying the print piece's type treatment and other elements mislead patients.

Business briefs: Aveo, Dynavax, Gilead, OPDP

Aveo CRL says company's kidney drug information is uninterpretable; Dynavax has to find more hepatitis B clinical trial patients; Gilead's hep C drug gets priority status; OPDP slaps Janssen and Sigma Tau with untitled letters.

Business briefs: Teva, Celgene, Komen, Apple, OPDP

Plan B age limits retained and rejected, Celgene drugs gets expanded indication, Komen cuts back on walks, Apple is policing medical apps, OPDP director's Q&A

Docs haven't mellowed on DTC, snap poll suggests

Docs haven't mellowed on DTC, snap poll suggests

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The FDA wants to know how physician attitudes towards direct-to-consumer advertising have evolved since the agency last asked them, in 2002. If a snap poll by CMI/Compas is any indication, drug companies probably won't like the answers.

OPDP takes an integrated approach to ad reviews

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FDA's Office of Prescription Drug Promotion is taking an integrated approach to reviewing promotional materials and shedding its consumer- and professional-directed silos.

AMARC Angst: Has FDA put pharma Facebook "Likes" in the crosshairs?

AMARC Angst: Has FDA put pharma Facebook "Likes" in the crosshairs?

What the agency writes in a recent warning letter to a dietary supplement firm is instructive with regard to "Liking" off-label posts.

Sequester cuts could snarl approvals for years

Sequester cuts could snarl approvals for years

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With sequester cuts taking effect and no sign of a deal to end them in sight, FDA stands to lose 5% of its 2013 budget—though coming five months into the Federal fiscal year, it will feel more like 9%—and while the agency has said it has no plans at present for layoffs, it's certain the approvals process will slow as the agency absorbs the loss.

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As US pharma continued its quest for a Grand Prix at the Lions Health international festival of creativity, MM&M went on location to Cannes, France. Missed our coverage from June? Now, we're giving you an opportunity to catch up on some of what you missed. Download our e-book on the two-day festival, recapping the event, rounding up the best of the speakers, offering perspective and listing all of the winners. Click here to download.


The most recent MM&M Skill Sets Live event surveyed a range of issues relating to one of the hottest promotional spaces in healthcare. Speakers and panelists at the morning-long session, including promotional- and multichannel-minded executives from GSK, Epocrates, Treato and Montefiore Medical Center, weighed in on topics designed to help marketers demystify the challenges associated with non-personal promotion. Click here.