FDA Issues Letter to Pfizer Regarding Violative Online Marketing - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Issues Letter to Pfizer Regarding Violative Online Marketing


ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA’s Division of Drug Marketing, Advertising, and Communication (DDMAC) issued a letter to Pfizer’s vice-president of US Regulatory Affairs regarding its online resources page for Lipitor (atorvastatin calcium) tablets. The letter, which was brought about as part of the agency’s Bad Ad program, cites that the webpage is misleading because it makes representations and/or suggestions about the efficacy of Caduet (amlodipine besylate/atorvastatin calcium) tablets, Chantix (varenicline) tablets, and Norvasc (amlodipine besylate) tablets without communicating risk information associated with the use of these drugs.

The letter reviews the FDA-approved indications and side effects for these products and notes that DDMAC sent Pfizer a letter in 2009 regarding sponsored links on Internet search engines for several of its products, including Caduet and Chantix. Those links were deemed misleading as well and “DDMAC is concerned that Pfizer is continuing to promote its products in a similarly violative manner,” states the current letter.

Promotional materials that include the name of a drug but not its indications are required to disclose risk and other information, states the letter. Otherwise, the materials are considered misleading.

Chantix in particular has a boxed warning, which was omitted in the webpage, and the lack of risk information about all the products noted on the webpage “suggests that these drugs are safer than have been demonstrated,” states the letter.

DDMAC has asked Pfizer to immediately stop disseminating the promotional materials and to submit a response letter to the agency by Sept. 14, 2011.


See Related Pharm Tech Articles:

FDA Reviews First Year of Bad Ad Program

FDA to Study Online Drug Marketing

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
29%
Oversee medical treatment of patients in the US.
11%
Provide treatment for patients globally.
7%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing
From Generics to Supergenerics
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here