FDA, Fair Balance and Social Media
Mark Senak social media advocate and author of the EyeonFDA blog has been spot on with his commentary on the recent public hearings held by FDA to unravel the social media conundrum facing the life sciences industry. Despite its good intentions, the agency is intent on applying an anachronistic method of developing guidance (designed for processes that undergo incremental changes) for a technology that changes rapidly and is ill-defined. In other words, they are trying to force a square peg into a round hole—it simply won't work! As duly noted by Mark, FDA seems focused on inconsequential and banal issues like fair balance. The whole concept of fair balance has never been

Clinical Trial Recruitment and Social Media
Recruiting patients for human clinical trials has become challenging over the past five years or so. Inclusion criteria have become more stringent and cost of running Phase III clinical trials has skyrocketed.  This has forced life sciences companies and clinical research organizations to be creative in recruiting patients. Traditional methods including print and radio advertising are no longer working. I previously wrote a piece on the

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.

And Now for Something Completely Different: North Carolina-based Talecris to Add 259 Biomanufacturin
Talecris Biotherapeutics announced that it will add 259 jobs as part of a $269 million expansion of its manufacturing facility in Clayton, NC. The RTP-based biotech company already employs more than 3,000 people world wide (2000 in the Raleigh-Durham area and 1,500 in Clayton) and plans to use the 259 new hires to staff its newly expanded manufacturing facility at the Clayton site. The jobs being added will have an average annual salary of $51,066, excluding benefit substan

Bugs, Drugs and Patents
I suspect that many of you (after reading the title of this post) might be expecting another rant about the need for new antibiotics to treat infections caused by multiple drug resistant strains of bacteria. Sorry to disappoint you because that isn’t what this post is about. After reading and listening to several seemingly disparate radio and newspaper stories this morning, I decided to combine three different stories into a single post that touches on several common themes. First, I heard a story on NPR this morning (while driving