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 DDMAC

Pfizer, Valeant and Acorda hit with untitled letters

July 10, 2012

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.
 

Sobi, Watson get OPDP untitled letters

June 29, 2012

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

Companies balk at "burdensome" DTC TV pre-review plans

May 31, 2012

The FDA's draft guidance on a planned move to mandate pre-review of TV ads for most prescription drugs and biologics would be unduly burdensome, say manufacturers, and maybe unconstitutional, says PhRMA.
 

FDA to study "corrective" ads

February 29, 2012

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

FDA study casts doubt on danger of "distracting visuals"

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

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

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

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FDA issued draft guidance on mobile medical apps, focusing narrowly on those programs that augment regulated medical devices or turn mobile devices into medical devices.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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.
 
  

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

MAHF 2013: Honors Class

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