DDMAC

FDA study casts doubt on danger of "distracting visuals"

Matthew Arnold January 31, 2012

An FDA study looking at the power of background visuals to distract viewers from the often-ominous risk info read in the "major statement" section of TV drug ads found no evidence that consumer understanding of risk info is affected by the "emotional (affective) tone of images.

Say so long to DDMAC as FDA's OPDP levels up

Matthew Arnold September 19, 2011

The FDA gave its Office of Medical Policy a long-awaited org chart upgrade, making it a "super office" and giving the department formerly known as the Division of Drug Marketing, Advertising and Communication, or DDMAC, a new acronym: OPDP.

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).

FDA guidance exempts most pharma apps from scrutiny

Matthew Arnold July 19, 2011

FDA issued draft guidance on mobile medical apps, focusing narrowly on those programs that augment regulated medical devices or turn mobile devices into medical devices.

Pharma digerati push for online guidelines

Matthew Arnold June 16, 2011

Frustrated by FDA inaction on guidance for digital marketing and social media, a host of industry players are banding together to form a nonprofit that can hammer out consensus on a way forward.

Facebook: pharmas must enable comments by August 15

Matthew Arnold May 24, 2011

Facebook sales reps told pharmas last week that they can no longer disable commenting on their non-brand-specific pages, potentially exposing them to flame warriors, spammers, adverse events reports and discussion of off-label uses that might call down the wrath of DDMAC.

FDA to probe website DTC risk/benefit presentation

Matthew Arnold April 28, 2011

The FDA announced plans to study online consumer advertising for prescription drugs in order to resolve "a number of questions surrounding how to achieve 'fair balance' in online DTC promotion.

Social media "power users" favor letting companies socialize, survey finds

Matthew Arnold April 05, 2011

Social media "power users" value interaction with healthcare companies want them regulated but around, according to a WEGO Health survey.

FDA again delays promised social media guidance

Matthew Schwartz March 30, 2011

The FDA has once again postponed the release of its first draft guidance for social media.

DDMAC's Abrams gives update on policy making

Marc Iskowitz February 08, 2011

The director of the FDA's Division of Drug Marketing, Advertising and Communication (DDMAC) could not give a completion date for guidelines on use of social media in promotion.

Boniva print ad hyped efficacy, says DDMAC

Matthew Arnold January 26, 2011

A print ad for Genentech's Boniva overstated the osteoporosis drug's efficacy, said the FDA's Division of Drug Marketing, Advertising and Communication in an untitled letter.

Sunovion refreshes Lunesta campaign

Marc Iskowitz January 12, 2011

Sunovion Pharmaceuticals quietly mothballed a Lunesta TV ad that drew FDA scrutiny, in favor of a spot that reprises the sleep drug's familiar mascot.

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.

Company news: social media guidelines

December 21, 2010

DDMAC pushed back its hotly-anticipated social media guidance, originally slated for the fourth quarter of 2010, to the first quarter of 2011.

DDMAC pokes Allergan on eye drop direct mail

Ben Comer December 07, 2010

Allergan has a superiority complex when it comes to marketing its ophthalmic drops, as evidenced by a second DDMAC Untitled Letter posted online yesterday.

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 slaps Alcon convention graphic

Ben Comer October 26, 2010

A convention graphic for Alcon's Travatan Z, an ophthalmic drop, broadened the product's indication and made unsubstantiated superiority claims, according to a Division of Drug Marketing, Advertising and Communications (DDMAC) Untitled Letter.

DDMAC slaps Premarin patient testimonials, Acuvail journal ad

Ben Comer September 14, 2010

Patient testimonial videos on the brand.com homepage for Wyeth's (now Pfizer's) Premarin overstated the drug's efficacy and minimized risks, while a journal ad for Allergan's Acuvail made unsubstantiated superiority claims, overstated efficacy, broadened the drug's indication, and omitted risk information, according to a pair of untitled DDMAC letters.

Novartis Facebook Share widget provokes DDMAC letter

Ben Comer August 05, 2010

A Facebook Share widget found on Novartis' Tasigna website provoked a DDMAC Untitled Letter, the fourth DDMAC communiqué Novartis has received this year.

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.

FDA looks beyond balance in study of efficacy info

Matthew Arnold July 07, 2010

Having analyzed the presentation of risk information in DTC ads and product labeling, FDA is looking at how the potential benefits of prescription drugs are communicated.

Intuniv patient kit draws DDMAC untitled letter

Matthew Arnold June 30, 2010

Patient materials for Shire's ADHD drug Intuniv presented unsubstantiated effectiveness and superiority claims and downplayed important risk info, said the FDA's Division of Drug Marketing, Advertising and Communication.

Sepracor's 'boxing bed' ad hit with DDMAC untitled letter

Marc Iskowitz June 21, 2010

A 60-second TV ad for insomnia drug Lunesta, which portrayed a woman fighting for sleep in a bed-turned-boxing ring, drew an untitled letter from regulators.

How's my detailing? Dial 1-877-RX-DDMAC

Matthew Arnold May 11, 2010

The FDA is asking healthcare professionals to keep an eye out for violative promotion and to call 1-877-RX-DDMAC or emailing badad@fda.com when they see it. "Recognize and report" is the message of the agency's Bad Ad Program, an educational outreach effort by the Division of Drug Marketing, Advertising and Communications (DDMAC) that will "help healthcare providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency," according to DDMAC director Tom Abrams.

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 letter scolds Rozerem sales aid

Ben Comer March 23, 2010

A "sell sheet" used to promote Rozerem to doctors contained unsubstantiated superiority claims and omitted risks associated with the drug, according to an untitled DDMAC letter posted online last Friday.