PhRMA pushes for dismissal of Integrilin off-label case, a recent FCPA settlement reveals a shift in DOJ thinking, European companies are not sure how to handle informed consent with EFPIA, and another organization wants CMS to keep the CME exemption in the Sunshine Act Final Rule.
Cue the heavenly choir; all is right with the world once again. Football season is here! The college season kicked off with some unexpected upsets, unexpected blowouts (Johnny Who? Texas A&M is here to play, y’all!), and even disruptions due to weather. The pros started the season with a kick this past weekend. The next several months are sure to be full of excitement as we get our gridiron on. For now, it’s back to the real world, as we take a look at the latest in compliance-related news with this week’s compliance News in Review.
Kicking off this week edition is PhRMA and its request to a California federal court to dismiss an off-label case on First Amendment grounds. The suit was filed by a whistleblower who alleges the three companies violated the FDCA by using truthful, off-label statements to promote a drug. PhRMA says the claim was nullified through the Supreme Court decisions in Sorrell v. IMS and the U.S. v. Caronia. According to the organization, healthcare professionals need accurate, up-to-date information about uses of medication, and neither the government nor the whistleblower alleged that the information provided about the drug was inaccurate.
The recent Smith and Wesson FCPA settlement reveals a couple of new additions to the government’s playbook, which businesses might want to note. First, the case appears to be signaling a shift in the DOJ and SEC’s focus on “high value targets” to those involving small and mid-size companies. Next, in the charges against Smith and Wesson, the internal controls violations centered on the company’s lack of an adequate compliance program, rather than financial documentation. The government noted that there was a policy prohibiting bribery in place, but the company had no process for ensuring the policy was followed.
A recent article from FCPA Professor lists four attributes of a strong compliance program that can be gleaned from a successful football program. First, understand the playbook. Effectively communicating the playbook is the first step toward becoming a successful team. Likewise, FCPA training should be executable by all employees. He suggests companies don’t need to train employees to be FCPA experts, but rather, provide them with “FCPA goggles” by which they can discern if actions are potentially problematic. Second, execution by all team members is key. More FCPA violations occur from the actions of employees doing the day-to-day work, rather than those in the C-suite or Board. Third is having a flexible playbook. A company needs to take a look at its compliance risks, and manage its own risks, not those of another company. Last but not least, play hard, but not too hard. A business can run into issues (penalties) when it competes too aggressively.
Tackling informed consent in regards to the EFPIA Disclosure Code is proving to be challenging for many companies. Data privacy laws in European countries require that companies obtain consent from healthcare professionals (HCPs) and healthcare organizations (HCOs) prior to publishing any data about transfers of value between the company and HCPs or HCOs. To complicate matters, companies also need to manage consent for direct and indirect payments. At a recent aggregate spend conference, audience members were polled as to how their company planned to handle managing consent. Most of the audience was still unsure of how it would be handled and nearly 20% said their company planned to manage consent directly, as opposed to turning it over to a third party.
The CME Coalition is jumping on the pile with comments regarding CMS’ proposal to eliminate the CME exemption from Sunshine’s Final Rule. The Coalition says the idea of eliminating the exemption is problematic because it requires manufacturers to report payments if they become aware of the identity of the payment recipient(s) within 18 months of the grant. In its comments, the organization suggested that CMS keep an explicit definition as to what constitutes accredited and certified CME, and revise the language in the CMS exclusion to be more specific.
The clock is ticking down on this edition of the Week in Review. We close with the suggestion that if your 2015 compliance training playbook needs refreshing, the PharmaCeritfy™ suite of compliance training solutions offers the eLearning modules and mobile apps you need to prepare your team to compete in today’s regulatory environment.
Have a great week everyone!