The PharmaCertify™ Team

May we take a moment and celebrate the start of another week? We know…who celebrates the start of a week? Normally, we’d be right there with you, but we are now just a few days away from the start of March! Finally, spring (almost). We realize there’s still cold and snow to be had, but don’t you feel like budding trees and blooming flowers are almost at hand when we cross into March? So, with those happy thoughts, we march right into this week’s News Week in Review.

The U.S. Chamber of Commerce is renewing its fight for change to the FCPA. The group sent a letter to officials at the Department of Justice and Securities and Exchange Commission saying they hoped that the guidance would continue to be updated as FCPA compliance evolves. The Chamber again brought up its desire to see a “compliance program defense” option for companies to protect them from rouge employees who pay bribes, despite the company’s efforts to quell that activity. The Chamber also called the agencies to task for not providing hypothetical situations on the definition of foreign officials or instrumentalities. In response to the letter, the DOJ said they welcome a continuing dialog on FCPA guidance. The SEC has not issued a comment.

According to an anonymous complaint filed with PMPCA, the party was in full bloom at a medical conference overseas, and that party was hosted by Roche. The complaint alleged that Roche employees were having a drunken fête with several physicians attending a conference. According to the complaint, shots flowed like lava at the rowdy affair, and eventually one person was ejected from the bar. Roche was censured for breaking one clause of the ABPI code, “high standards must be maintained at all times.” The PMPCA’s investigation did not yield definitive proof that doctors were entertained at the gathering.

Maryland Attorney General, Douglas F. Gansler, has marched into court and filed suit against GSK for falsely saying three of its diabetes drugs were better than others on the market. The suit also claims the company withheld information that the drugs could increase the risk of a patient suffering heart attacks, liver damage and a number of other side effects. The state spent $38 million dollars on the drugs, and is suing to recoup that money as well as the money the state spent to treat patients who suffered side effects.

A survey conducted by MedPage Today shows that many physicians think Congress should go fly a kite where Sunshine is concerned. Following the release of the final rule, MedPage Today surveyed 2700 physicians for their feelings about the Sunshine Act. While Congress received a heap of criticism from the respondents, a large number of them did not have any particular negative feelings about the law itself. Close to 38% felt it was a great idea, 20% felt the law wasn’t strong enough and 17% said it was good idea, but wouldn’t change anything. Even with those good vibes, a quarter of the respondents felt the law represented an invasion of their privacy.

CME providers have a little spring in their step following the release of the final rule for the Sunshine Act. The CEO and president of the ACCME, Murray Kopelow, M.D, commented that the final rule was validation of the ACCME standards for CME. He went on to say he was glad CMS recognized the value of accredited CME and the value of the ACCME standards in protecting the independence of accredited CME programs.

Well, that’s it for the week. We hope, like us, you’re looking forward to warmer temperatures and sunshine (that’s sunshine with a lower case S of course). The home stretch approaches as we enter March on Friday. If it’s time to freshen up your compliance training, PharmaCertify can help, with the custom and off-the-shelf training you need to prepare your staff for today’s evolving marketplace. And now that CMS has released the final rule on the Sunshine Act, don’t forget to ask about our new training module covering the law.

Have a great week everyone.