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Bayer's New Life-Work Balance Program?


I'm sure you've all been following the lawsuit, and wondering about whether a corporate culture and mindset may have existed at the company that might have driven six professional women to take this drastic step.  It was discussed yesterday in an unusual source (you may have to scroll to see the last frame).


cGMP Whistleblowing Webcast; 50 Ways to Bad Outsourcing


Our March cover story looks at the potential growth of pharma cGMP whistleblowing, and features interviews with qui tam lawyer Ken Nolan of Nolan and Auerbach, FDA compliance expert John Avellanet, consultants Johnny Guerra and Michael Gregor, as well Neil Getnick and Lesley Ann Skillen, who represented Cheryl Eckard in her epic case.  Mr. Avellanet, Ms. Skillen and Mr. Getnick, as well as Mr. Nolan will speak in a webcast series starting April 7 on that topic. 


Which Directives Should FDA Scrap, Under Obama's Order?


In January, President Obama issued an executive order demanding that government agencies, including FDA, submit a plan for reviewing existing regulations. Their aim, he said, should be to examine rules that could be outmoded, ineffective, insufficient or excessively burdensome, and to "modify, streamline, expand or repeal" them based on accumulated knowledge.


Can a Defensive, Fire-Fighting (and Data Diving) FDA Be a Strong and Effective Enforcer?


As reported recently by Phil Taylor in Securing Pharma, Leaders of the House Energy and Commerce Committee (I won't name any political parties) have written to FDA Commissioner Hamburg, demanding that FDA release documents from its prior, extensive investigations into U.S. heparin supply chain safety.


The Future Pharma Supply Chain: Be Very Afraid?


Big consulting groups like to publish big reports on big topics, to establish their authority and expertise, and of course to impress potential clients with how smart and visionary they are. The glossy PDFs have big titles, and are punctuated by bold statements about industry transformations. “In the next decade, the pharma world as you know it will change.”

As readers, we can be forgiven if we feel ill-equipped to face the future—at least without the calming, reassuring hand of a high-paid consultancy.


"First Things First: Fix the FDA" (From Those Who Practically Destroyed It)


Newt Gingrich, Andrew von Eschenbach and Wayne Oliver, of the Center for Health Transformation, wrote a blog post recently that you might find interesting.


How are Pharma CEO's Like the Ostrich?


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The ostrich has become a staple of many pharmaceutical science presentations of late, symbolizing an industry that is reluctant to change. Perhaps it could symbolize some of the more shortsighted pharma CEO's at this point in the 21st century. With all due respect, as CEOs face a tough balancing act today, I have a few questions for this elite group:


Video Message to Gay Teens Brings Support and Slurs within Lilly


Recently, a group of gay Eli Lilly professionals produced a video in support of gay teens. Writes BNET's Jim Edwards, Lilly was one of few corporations to participate in the recent, far-reaching "It Gets Better" campaign.


Pharma Jobs: Could 2011 Be the Year of the Hire?


In our February issue, we’ll share results of our annual job satisfaction and salary survey. Thanks so much to the hundreds of you who have already participated. (There’s still time if you haven’t—click here.) The early returns are showing that you are, more than ever, feeling overworked, underappreciated, and burned out.


FDA Culture Change: Was Frustration Behind Dr. Sharfstein's Retreat?


peeling an onion I'm sure we all remember the industry's cool response when Dr. Sharfstein joined the FDA. This week brought news that he will be leaving the Agency.