Friday, April 8, 2011

Grading Pharma's Use of YouTube

Social media is everywhere. Facebook now has more than 600 million active users and businesses have been getting in the game for some time now. Even President Obama announced his bid for re-election through YouTube and Twitter. But with lacking guidance on social media from the FDA (announcing even further delays in issuing guidance), the Pharma industry has been cautious about entering this space. Cautious . . . but not absent.

How is pharma doing in executing in the social media space? I recent came across a great posting by Kelsey Shantz 'Grading Pharma's Use of YouTube (A First Look).' To see how companies including Pfizer, GSK, J&J, and BI have been rated, read her blog here.

Friday, July 16, 2010

Are DTC Ads Fair and Balanced?

According to Prevention Magazine's 13th annual national survey Consumer Reaction to DTC Advertising of Prescription Drugs, the majority of respondents believe TV and magazine DTC ads are adhering to the FDA's "fair balance" regulation (this mandate requires that pharma DTC ads present a fair balance of risk and benefit information). But, while consumers are now accustomed to hearing risk information and its recognizable format on TV ads, there responses indicate that there is much room for improving online DTC ads in this area. Other survey questions provided insights around use of social media for health information and type of information consumers sought to obtain.

To find out more about the survey results, click here.

Friday, July 2, 2010

DDMAC Warning / Untitled Letters - Impact on Pharma

As many of us know, the FDA's DDMAC has been increasing its staff and stepping up its issuance of warning and untitled letters (also called notice of violation letters) for violative promotional activities. In fact, according the FDA's website warning and untitled letters have risen from 21 in 2008 to 41 in 2009. Mid-way through 2010, we have already seen the number hit 38.

As the number of these letters continue to rise, I wonder how this is impacting the perspectives of promotional material reviewers. Is the first thought around communicating messages with the patient in mind or regulators? The reality is that regulatory compliance is a part of our everyday lives. But I hope that marketers and reviewers continue to place the safety and concerns of patients first.

Friday, June 11, 2010

Blue Cross Blue Shield of Texas sues Pfizer over allegations of deceptive marketing

As if it wasn't enough for Pfizer to receive a warning letter from the FDA for failing to report serious and unexpected potential adverse events associated with some of its marketed drugs, the company is back in the news regarding allegations of deceptive marketing. While Pfizer has denied any allegations or wrong doing, the company recently agreed to pay "the largest health care fraud settlement in the history of the Justice Department for similar allegations." To find out how many billions of dollars this amounted to, see story here.

Wednesday, June 9, 2010

The Big Business of Free Drug Samples

Find out which pharma company leads the pack, having provided 101 million free samples worth $2.7 billion in 2007. See a WSJ article about this topic here.

FDA Guidance on Social Media

The increasing prevalence of social media into our everyday lives has not escaped pharma. However, "even though various business sectors have fervently embraced social media as a product marketing tool, FDA-regulated industries have been slow to adopt this practice" write Areta Kupchyk and Kevin Madagan. This is largely due to the absence of clear guidance from the regulatory agency on internet marketing activities including social media. For more information about the author's thoughts on the pending FDA guidance on social media, click here