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.
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.
The FDA's Office of Prescription Drug Promotion served Sobi and Watson with untitled letters.
The FDA's draft guidance on a planned move to mandate pre-review of TV ads for most prescription drugs and biologics would be unduly burdensome, say manufacturers, and maybe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.
The FDA will study the impact of corrective advertising on consumer misperceptions of drug safety and efficacy.
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.
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.
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FDA issued draft guidance on mobile medical apps, focusing narrowly on those programs that augment regulated medical devices or turn mobile devices into medical devices.
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 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.
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" value interaction with healthcare companies want them regulated but around, according to a WEGO Health survey.
The FDA has once again postponed the release of its first draft guidance for social media.
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.
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 Pharmaceuticals quietly mothballed a Lunesta TV ad that drew FDA scrutiny, in favor of a spot that reprises the sleep drug's familiar mascot.
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 pushed back its hotly-anticipated social media guidance, originally slated for the fourth quarter of 2010, to the first quarter of 2011.
Allergan has a superiority complex when it comes to marketing its ophthalmic drops, as evidenced by a second DDMAC Untitled Letter posted online yesterday.
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.
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.
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.
A Facebook Share widget found on Novartis' Tasigna website provoked a DDMAC Untitled Letter, the fourth DDMAC communiqué Novartis has received this year.
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.
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.
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.
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.
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.
The FDA is asking healthcare professionals to keep an eye out for violative promotion and to call 1-877-RX-DDMAC or emailing firstname.lastname@example.org 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.
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