Warning Letter

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.