FDA Enters the Digital Age by Issuing 22 Warning Letters to Web Site Operators

The public hearing held by FDA last week in Washington DC to address social media and promotional advertising in the pharmaceutical seems to have altered the agency’s perspective on all things digital. Today, according to a press release, marked the agency’s completion of a coordinated week long international effort called the International Week of Action (IIWA) that was intended to curb illegal actions involving medical and pharmaceutical products.

During the effort, the FDA's Office of Criminal Investigations (OCI), in conjunction with the Center for Drug Evaluation and Research and the Office of Regulatory Affairs, Office of Enforcement, targeted 136 Web sites that appeared to be engaged in the illegal sale of unapproved or misbranded drugs to U.S. consumers. None of the Web sites are for pharmacies in the United States or Canada.

The agency issued 22 warning letters to the operators of these Web sites and notified Internet service providers and domain name registrars that the Web sites were selling products in violation of U.S. law. In many cases, because of these violations, Internet service providers and domain name registrars may have grounds to terminate the Web sites and suspend the use of domain names. Apparently, FDA has taken to sending warning letter en masse—it previously sent identical warning letters to 14 different pharmaceutical companies for improprieties associated with Google search ads.

Is there really a sea change taking place at FDA? Will a carefully and thoughtfully- crafted guidance document on the use of social media be next; now that the agency is no longer afraid to navigate the Internet? Only time will tell....hopefully sooner, rather than later!

Until next time...

Good Luck and Good Surfing!!!!!!!!!

 

It Had to Happen Sooner or Later--Pharma Has Discovered YouTube

First, King Pharmaceuticals posted a non-branded high blood pressure video on YouTube in early 2007. Next, Novartis added a 60-second commercial (as part of its Fluflix campaign) asking people to submit videos about what it's like to have the flu. Earlier this year, Insmed upped the ante by posting a video lobbying for new legislation for the approval of follow-on biologics in the US. However, these pharma assaults on YouTube pale in comparison to the launch of Johnson & Johnson’s health channel on YouTube earlier this week.

The channel currently showcases a small selection of health information videos created by NBC News chief medical editor Nancy Snyderman while she worked J&J. Video sites, like YouTube and Vimeo, offer pharma companies a place to feature expensive off media advertising assets (that are currently collecting dust) and to post ads for new drugs and products that are ready for launch.  J &J is the first pharma company to recognize that it can leverage the current social media craze to increase its visibility, sell more drugs and bolster its stock price!

While companies could host videos on their own websites,YouTube’s massive traffic of more than 80 million users offers companies a much larger and diverse audience. And unlike blogs or forums, pharma companies have complete control over the content of the videos that they post on video websites. Moreover, they don't have to worry about negative comments being left after a post (YouTube comments can be turned off), and they can brand and edit video content to target a particular demographic or audience. Finally, videos can be changed or removed by companies as needed.

The bad news is, that like all other forms of media on the Internet, there are currently no regulations for videos posted by pharma companies on video websites sites like YouTube. In other words, pharma companies can do or say whatever they want in the videos that they post—never a good thing! I suspect that at some point FDA will draft a guidance document or two on the topic. But pharma companies need not worry, it will likely be many years before the agency divines regulations guiding the messaging and content of online pharmaceutical videos.

The appearance of pharma videos on YouTube, and the growing number of pharma profiles on social networking sites indicates that pharma is ready to embrace social media as the next best thing since DTC advertising. I was wondering what took them so long?

I hope that J&J doesn’t start following me on Twitter!

Hat tip to Eye on FDA for the story!

Until next time,

Good Luck and Good Job Hunting!!!

June 2008-Web Picks

Kevin’s selections this month contains a wide variety of sites ranging from an Australian museum guide, to wildlife parks in Tasmania and online information-sharing and management capabilities.  If leeches are your thing check out this site and if you are a dragonfly aficionado this site will do the trick. An interesting site called the Fallacy Files provides insight into fallacies or so-called mistakes in reasoning.

As a sometimes medical writer, the site that piqued my interest was www.connotea.org— an online reference and information sharing-service.  The site provides you with easy and ready access to references, data and other information stored in your account on the site.  Kevin really likes this site and says “Connotea scores big time with this valuable tool for scientists.”  Check it out….

Until next time….

Good Luck and Good Web Surfing

May 2008--Around the Web

This is the first installment of Kevin Ahern’s Best of the Web at BioJobBlog. This month’s selection contains several technical sites that many practicing bioscientists will find useful. These include: Real Time PCR Primer Sets and RTPrimerDB. The selection that I found most interesting was Blogging the Biotechnology Revolution—although Kevin didn’t like the navigation features of this blog.

If you know of any websites, blogs, etc that you think are useful or interesting, please let me know.

Until next time…

Good Luck and Good Web Hunting!!!!!!!