OPDP

Pacira gets OPDP opioid promotion Warning Letter

Pacira gets OPDP opioid promotion Warning Letter

By

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

By

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

By

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The draft guidance is mostly procedural, and more guidance is expected, but experts say it does include some long-awaited clarity for advertisers.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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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

By

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.

Razzed for lax DTC self-policing, PhRMA accentuates the positive

Razzed for lax DTC self-policing, PhRMA accentuates the positive

By

PhRMA issued a terse response to a study claiming that ED drug advertisers more or less ignored the trade group's Guiding Principles for Direct to Consumer ads, a self-policing regime implemented in 2005 to fend off talk of a ban on drug ads.

Merck finds "dual modality" in DTC helps viewers grasp risks

By

A Merck study bolsters FDA's case for requiring that TV ads for prescription drugs present risks in text as well as the voiceover.

Company news: AstraZeneca, Alcon, Novo Nordisk

AstraZeneca's 7,300 layoffs were not the last word for 2012, Alcon gets hit with an untitled letter from OPDP, and Novo creates an all-diabetic sports team

With untitled letter, FDA signals press materials aren't exempt

By

The FDA has issued a rare untitled letter concerning a pitch letter - a reminder that the agency does not consider press materials to be exempted from its oversight.

OPDP tells Genentech to pull Tarceva vis aids

OPDP tells Genentech to pull Tarceva vis aids

By

FDA's objections include overstated efficacy and misleading art.

Pfizer, Valeant and Acorda hit with untitled letters

Pfizer, Valeant and Acorda hit with untitled letters

By

The drug industry may be settling in for a hot, lazy summer, but FDA's Office of Prescription Drug Promotion has been keeping busy, issuing untitled letters to Pfizer, Valeant and Acorda Therapeutics over allegedly violative promotions in recent weeks.

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.