The PharmaCertify™ Team

Despite the doom and gloom “allegedly” predicted by the Mayans, 2013 arrived, and we’re all here raring to go for a new year! Well, maybe not raring…quite yet, but there is something rejuvenating about the turn of the year isn’t there – contemplatively looking back on the past year while looking ahead to the new year with hope. So time marches on, and so does the news. Let’s take a look at the happenings between the holidays in this week’s News Week in Review.

Victory Pharma didn’t go out on the happiest of notes in 2012, agreeing to pay $11.4 million to settle criminal and civil allegations surrounding the marketing of several of its products. Of the total settlement, $1.4 million was to resolve criminal allegations of violating the Anti-kickback Statute. The remaining $10 million is to resolve allegations of violating the False Claims Act. The case was brought by a whistleblower who was a former company sales representative.

And speaking of sour notes, 2013 didn’t start happily for a physician who blew the whistle on Amgen. A circuit court has denied the NJ physician’s petition for a court hearing to challenge the government’s recent $612 million dollar civil settlement with the company. The physician claims the government told him to either agree with the settlement or face the possibility of seeing his case dismissed. He declined to sign on, and now the government has asked the court to dismiss the case against Amgen. A lawyer for the physician says his client did not agree to the settlement because government prosecutors would not inform him of his share of the settlement.

A new survey from Ernst and Young shows that mid-market UK companies need to put learning about the UK Bribery Act on their resolution list for 2013. The survey of procurement managers and directors reveals that 64% of mid-market companies do not understand the law. Of those familiar with the law, just over half vet their suppliers for information on how to comply.

As you may know, in December of 2012 Eli Lilly settled allegations of violating the FCPA. In case you haven’t had time to read the enforcement action against Lilly, we have good news for you; Tom Fox has posted a brief video with an overview of the enforcement action, along with the specific internal audit function lapses cited by the government.

The American College of Obstetrics and Gynecology (ACOG) is ringing in the New Year with an update to its policy on professional interactions with the industry. The new policy encourages ACOG members to refrain from taking part in speaker’s bureaus; discourages professionals from accepting gifts (including meals) tied to promotional information; and encourages the provision of  vouchers or samples only to those with a “true need.”  The new policy also encourages physicians to  attend device training conducted by a professional association that has CME accreditation or only attend training focused on the FDA-approved use of the device. The policy also covers ghostwriting and research.

So is the idea of updating your compliance courses on your list of 2013 resolutions? How about investigating mobile technology for expanding the delivery of compliance content? Pharmacertify can help, with custom and off-the-shelf solutions designed to integrate compliance training throughout your company. Check out our course listing and mobile learning options at www.pharmacertify.com.

Happy New Year from all of your friends at the News Week in Review! Have a great start to the year everyone.