National Consumers League

Is the FDA showing Gender Bias in Sexual Dysfunction Treatments?


The Food and Drug Administration’s approval of Viagra in 1998 sparked a revolution in the treatment of men’s sexual dysfunction. It changed the way we talk about sex and opened the door to a seemingly never-ending parade of newly-approved and highly-publicized treatments for low testosterone, erectile dysfunction, and everything in between.
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In The Headlines

NAVEX Global

Prevention is Worth a Pound of Cure – Especially When the Subject is Corruption Landscape


Together with the Securities and Exchange Commission (SEC), the U.S. Department of Justice (DOJ) has made good on this commitment, bringing many high profile, and high recovery, enforcement actions against pharmaceutical and device manufacturers over the past several years. In 2012, U.S. Foreign Corrupt Practice Act (FCPA) enforcement fines and penalties reached a high of $142.2 million. The 2011 Johnson & Johnson case became the largest drug or device settlement to date totaling $70 million in recoveries2. There has been increasing cooperation across the ocean between the DOJ and the UK Serious Fraud Office (SFO) in anti-corruption enforcement efforts, more individuals are being prosecuted and the SEC/DOJ are using more creative enforcement techniques3. It appears that FCPA prosecutions in 2014 will continue, with “even higher criminal penalties and more cooperation from other countries, according to new FCPA reports from three law firms.” 4
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Topic of Discussion

CIS

Leaders- What Message Are You Sending About Compliance?


ATTENTION LEADERS, this article is for you! Everyone else, feel free to print this article and leave it on your boss’s desk.
MorascoThere has been plenty of talk recently about “proactive compliance”. Whether you are on the commercial side of the business or the R&D side of the business compliance is (or at least should be) always on your mind. Conferences, seminars, articles like this (and several other ones on this website) all talk about how in today’s current environment companies need to be proactive instead of reactive when it comes to compliance. Most articles and presentations will purport that to be proactive about compliance companies need to have processes and procedures that support compliance, ongoing and real-time monitoring and auditing programs, as well as training programs and compliance departments. Although I would agree that all of these pieces are essential to proactive compliance I would assert that the most important component to compliance is (drum roll, please) LEADERSHIP.
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