The PharmaCertify Team

With deference to Randy Newman, there are short things (okay, his song was really about short people, but you get the point) that are awesome. A shortened work week is just one example. While most of us enjoyed a shortened work week as we honored those who gave all in defense of our nation, there was no shortage of news for this week’s News in Review.

Want to minimize FCPA risk? A good due diligence and compliance program is the key, according to two government attorneys who spoke at the Compliance Week annual conference in Washington. The attorneys stressed that simply having a due diligence program on paper isn’t enough to make an investigator happy. The program needs to be active and tied to internal controls and internal auditing. The experts also emphasized that a good compliance program helps companies identify problems and resolve them quickly, pointing out that bribery doesn’t occur in isolation. When one incident is found, others are sure to follow. Companies that identify the issues and then lock down the problem are often rewarded during an investigation.

The UK Bribery Act is up for review, and that review will be focused on facilitation payments. According to a report by a top level government group, businesses are unsure about what processes they need to have in place to keep from being unfairly prosecuted for making facilitation payments when expanding overseas. The Serious Fraud Office had no comment on the review. The agency did say it had seven investigations of potential violations in process.

ISTA Pharmaceuticals agreed to pay $33.5 million in civil and criminal fines and penalties to resolve charges it promoted one of its drugs for unapproved uses and paid kickbacks to physicians. That number may be small in comparison to other industry settlements, but the fall out is still significant. The company also pled guilty to violating the FDCA and the Federal Anti-kickback Statute. In addition to the guilty plea and monetary fines and penalties, ISTA and its parent company, Bausch+Lomb, have entered into a Divestiture Agreement with HHS. ISTA’s products will be excluded from the Federal healthcare programs, and all of the company’s assets will be transferred to Bausch+Lomb or a Bausch+Lomb subsidiary. The exclusion will last 15 years.

Dealing with the Sunshine Act can be quite an undertaking, but two experts from the Chicago law firm, Freeborn & Peters, LLC, have drilled it down to just four short steps. First, determine if the law applies to your company. (seems rather obvious, doesn’t it?) Second, put a system in place to collect the data. Next, examine the payments you make and get strategic about the data. According to the two attorneys, companies need to ask themselves if certain payments will undermine relationships with physicians and researchers. How will those payments impact the business? They need to understand what payments will be reported, and determine what changes may be needed. Finally, take advantage of the 45 day period available to review data after it is submitted.

Medical Meeting professionals have no small task in collecting data for Sunshine reporting, and according to Sr. Vice President and CCO of Wright Medical Technology, David Garen, planners need to be prepared to back up those numbers. Speaking to a group of meeting planners, Mr. Green said the Sunshine dispute resolution process is going to require companies to access their  documents quickly in order to substantiate their numbers. He expects dispute resolution to be a big deal. Those using third-parties to manage meetings need to consider who holds the data, and what additional charges may result when third-parties are asked to produce the information in short order.

Well that’s the short and the short of it folks. And speaking of small (and portable), PharmaCertify now offers iPad-compatible modules and just-in-time apps that bring critical compliance content to your reps where they need it most – in the field and at their fingertips.

Have a great week everyone!