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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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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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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IT Compliance Spotlight on Pharma, Medical Device and Biotech Merger and Acquistions

Mergers and acquisitions are not a new trend in Life Sciences. We have seen pharmaceutical, medical device, and biotech companies growing through mergers and acquisitions for the last two decades. Today, many of these companies are operating with IT-related compliance issues and significant inefficiencies resulting from lack of planning and management fear of political nightmares when trying to consolidate and harmonize methodologies and compliance activities after a merger or an acquisition. Often, management is only concerned with validation activities that are related to hardware and software changes and are not aware of the impact of the integration of new business areas and process changes. We hear executives stating that they’ll consider validation activities once they determine the required changes to computer system architecture and applications. [Read more...]

Pharma in China – Compliance Challenges and Options

China poses unique compliance challenges for pharmaceutical companies, with several well-known foreign companies getting caught up in corruption investigations in the past year. President Xi Jinping has publicly made fighting corruption one of his cornerstone policies. Additionally, the DOJ and SEC have been quite vocal in recent years about their ongoing Foreign Corrupt Practices Act (FCPA) enforcement focus on the pharmaceutical industry, with a particular focus on China. In recent years, 10 investigations under the FCPA involving alleged violations in China by pharmaceutical and medical device makers. Finally, it’s been long known that the structure of the healthcare system and environment in China creates a high-risk industry. So why, despite knowing these things, did certain pharmaceutical companies recently find themselves embroiled in corruption scandals?
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Data Integrity: Make Sure This Hot Topic Doesn’t Burn You or Your Suppliers, Contract Manufacturers or Contract Laboratories

How confident are you that there are no data integrity issues within your firm, or within the many suppliers, contract laboratories or contract manufacturers you use in the development, manufacture and supply of your products or services?

There has been a noticeable increase in the past year or so in the number of significant enforcement actions taken by regulators, particularly the US FDA and the UK MHRA, related to data integrity. These have included the refusal to accept new product filings and the refusal to allow products to be marketed if manufactured at a site with known data integrity issues.
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