The PharmaCertify™ Team

It’s October and the frost will soon be on the pumpkin, the dreams of a World Series dance in the heads of some lucky baseball fans, and we lament the seemingly earlier and earlier arrival of holiday decorations in our shopping malls and on our city streets.

But before you stress over the prospect of being inundated yet again with the familiar barrage of holiday advertising and mall crowds, let’s take a few minutes to kick back, sip a bit of warm cider and fall into another edition of the PC Week in Review, with the United States Navy Concert Band’s performance of October, by composer Ed Whitacre, for musical accompaniment.

Senators Grassley and Kohl expressed their own bit of October surprise as they joined the chorus of voices questioning whether and when the rules pertaining to the Sunshine Act will be finalized. The October 1 deadline for drafting those regulations came and went without a word from the Center for Medicare and Medicaid Services (CMS). The Senators sent a letter to CMS questioning the agency on the implementation of the provision requiring manufacturers and group purchasing organizations to report all ownership or investment interest held by physicians or members of their family. CMS promptly deflected the blame onto the Office of Management and Budget, saying that agency is responsible for publishing the rule. Oh what a tangled web we weave.

It takes more than ghost and goblins to frighten the University of Rochester Medical Center…it takes the American Medical Student Association (AMSA). With what the organization describes as “the goal of removing drug companies from the practice of medicine,” the AMSA issues grades to American medical schools for their conflict-of-interest policies. The group gave URMC a C on its most recent report card and URMC responded by implementing new rules intended to plug the holes in its policies. The results: gifts from pharma and med device companies are banned and the use of free drug samples is permitted only in limited situations.

According to a new study, 60% of drug companies avoid the gray area of compensating key opinion leaders (KOLs) for the preliminary work associated with consulting services. The study, from Cutting Edge Information, found that the companies are hesitant to compensate for the time spent preparing for a consulting engagement to avoid any potential fines for overpayment. 100% of the companies surveyed did report that they compensate for any travel expenses associated with the consulting services.

If it’s October, it’s the beginning of a new fiscal year for the OIG and it’s time for the release of the OIG FY 2012 Work Plan. The agency posts a new plan every year and in great length (about 165 pages) it explains the activities the government will be monitoring throughout the fiscal calendar.

On the anti-bribery front, FCPA investigations often start where the buck stops. A new study, by Chadbourne and Parke LLP, reveals that top corporate officials are frequently the target of FCPA investigations. In fact, more than one-third of the 61 individuals who were the subject of government investigations under the FCPA in the last six years were top officials in their respective companies. Good anti-bribery training starts with the FCPA and that’s why more clients are utilizing the content in our Essentials of the Foreign Corrupt Practices Act module as a starting point for their comprehensive training.

Speaking of the FCPA, we wonder, if the recipients of a bribe aren’t identified as government officials, should a bribery conviction be dismissed? A Haitian man, who was convicted along with a co-defendant for conspiring to violate and violation of the FCPA and money laundering laws, filed a motion arguing that the government’s evidence was “to show that he knew that Haitian government officials were bribed.” Unfortunately for the defendant, Carlos Rodriguez, and his lawyers, defense lawyers in other cases have not had success in arguing that US has adopted too broad of a definition of “foreign official” to include anyone working for a state-owned enterprise.

Well, that’s it for another edition of the PC News. As we head into the final three months of the year, and you evaluate your 2012 training plan, remember, PharmaCertify offers the custom, and off-the-shelf training modules and mobile apps you need to truly integrate a culture of compliance into your company.

Have a great weekend everyone, and for those of you with baseball teams still in the hunt, good luck. For everyone else waiting for a championship or for finalization of details of the Sunshine Act, hope springs eternal and there’s always next year.