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Warning Letter

Business briefs: PwC, Novartis, iDoc24, FDA

April 10, 2013

PricewaterhouseCoopers says consumers are talking healthcare, but not about the good stuff; Novartis shuffles 120 Texas jobs; 73% of STD app queries came from men last month; FDA is keeping very busy; and OgilvyCommonhealth hires a consumer head

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

Peter Pitts March 08, 2013

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

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

Matthew Arnold November 20, 2012

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.

Sobi, Watson get OPDP untitled letters

Deborah Weinstein June 29, 2012

The FDA's Office of Prescription Drug Promotion served Sobi and Watson with untitled letters.

OPDP wants corrective ads for violative EpiPen TV spot

Matthew Arnold June 01, 2012

FDA's Office of Prescription Drug Promotion issued a warning letter to Mylan and Pfizer for an EpiPen TV ad that the agency said hyped the effectiveness of the drug.

FDA to study "corrective" ads

Matthew Arnold February 29, 2012

The FDA will study the impact of corrective advertising on consumer misperceptions of drug safety and efficacy.

Lipitor.com gets Bad Ad slap for cross-promotion sans risk info

Matthew Arnold September 06, 2011

Pfizer's Lipitor website touted the efficacy of Caduet, Chantix and Norvasc but failed to balance those claims with risk info for the drugs, according to an "untitled letter" from FDA's Division of Drug Marketing, Advertising and Communication (DDMAC).

DDMAC enforcement letters up 26% in 2010

Matthew Arnold December 28, 2010

The FDA's Division of Drug Marketing, Advertising and Communications has written 26% more enforcement letters to drug companies over promotional practices this year than it did in 2009.

DDMAC calls Ipsen white paper misleading, serves warning letter

Ben Comer November 11, 2010

Although no product was explicitly mentioned, DDMAC found plenty to dislike about a white paper and other unbranded materials circulated by Tercica, a subsidiary of the Ipsen Group.

DDMAC regulatory letters could double in 2010

Ben Comer July 22, 2010

New Year's Eve is five months away, but FDA letter-writers have already been prolific in 2010 on themes of risk omission, inflated efficacy claims, and unfair balance presentation as seen in promotional materials targeting physicians and consumers.

Luvox CR patient brochure gets warning for missing risk info

Matthew Arnold July 21, 2010

The FDA demanded that Jazz Pharmaceuticals halt dissemination of a patient brochure for Luvox CR and run corrective messages to counter inflated benefit claims and omission of risk information.

DDMAC warns Novartis on educational websites

Ben Comer May 05, 2010

FDA's Division of Drug Marketing, Advertising and Communications (DDMAC) took Novartis to school over educational websites the agency said went beyond disease awareness, and into brand promotion, according to a Warning Letter dated April 21.

DDMAC demands corrective messaging from three companies

Matthew Arnold March 16, 2010

The FDA hit three companies with warning letters for promotional materials on three drugs and requested corrective communications for all three.

Aricept TV spots hype benefits, says DDMAC

Matthew Arnold February 24, 2010

Eisai got an FDA untitled letter for two Aricept TV ads that the agency said overstate the efficacy of the drug.

DDMAC letter-writers off to a busy start of 2010

Matthew Arnold February 04, 2010

The FDA's Division of Drug Marketing, Advertising and Communications got off to a busy start in January, issuing nine enforcement letters.

DDMAC cites fishy Cymbalta fibromyalgia ads

Matthew Arnold January 14, 2010

The FDA issued an untitled letter upbraiding Lilly for Cymbalta consumer and professional ads.

King's all kid gloves on Embeda launch

Marc Iskowitz December 10, 2009

King's launch of Embeda, a pain drug containing morphine, demonstrates that even supposedly abuse-resistant narcotic products need to take a careful approach in their marketing.

FDA seeks input on social media regulation

Marc Iskowitz November 12, 2009

Will the FDA hearings on social media, which kicked off today, result in guidance specific to online media? That's the question on the minds of digital gurus converging on the capitol for two days of presentations on using social media in drug and device marketing.

Sanofi card trick draws warning

Ben Comer October 28, 2009

A promotional card for Sanofi Aventis's Uroxatral omitted indication and risk information, and also used outdated product labeling, according to a DDMAC warning letter.

King warned on Embeda VNRs

Matthew Arnold October 21, 2009

Video news releases for King's abuse-resistant pain drug Embeda drew a warning letter from FDA's Division of Drug Marketing, Advertising and Communications.

DDMAC lashes Allergan over Latisse website

Ben Comer September 17, 2009

DDMAC issued a warning letter to Allergan that singled out misleading aspects of Latisse's brand.com site.

DDMAC slaps J&J journal ad, Pedinol mailer

Matthew Arnold August 27, 2009

The FDA issued an untitled letter to J&J for a journal ad for its athlete's foot treatment Ertaczo Cream, saying the ad omits key risk info, broadens the indication and overhypes efficacy.

DDMAC warns Abbott on Kaletra promo

Ben Comer July 31, 2009

FDA warned Abbott about a patient testimonial DVD for its HIV drug Kaletra, starring Earvin "Magic" Johnson.

Web Exclusive

Angelina Jolie's fearless but flawed message

Paul Oestreicher, Ph.D. May 17, 2013

Angelina Jolie's story raises important questions about education, outreach and access—but her nod to holistic treatments is less helpful

Podcasts

How to engage even the busiest physicians

March 04, 2013

Sponsored by TRUE Health + Wellness. The increasingly demanding schedules of healthcare professionals continue to narrow the window of opportunity for pharma sales teams, and, as a result, marketers are focusing more on non-personal promotion. However, there's a lot more to it than simply bombarding physicians with brand messages, as Anne Stroup, Managing Director at TRUE Health + Wellness, explains to MM&M's James Chase in this special podcast presentation.

2013 Hall of Fame Inductees

An entertaining look at the extraordinary lives and careers of the Medical Advertising Hall of Fame's 2013 inductees: Peter Frishauf, Dorothy Philips and David Labson. Clips produced by JUICE Pharma.

Slideshows

Peter Frishauf, founder of Medscape, delivers his acceptance speech.

MAHF 2013: Honors Class

A gallery of images from the 2013 Medical Advertising Hall of Fame induction dinner

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