The PharmaCertify™ Team

It has been quite a week! Osama Bin Laden..departed. And while that story rightly dominated the headlines, there were developments in the world of healthcare compliance. So without further adieu, here’s this week’s PC News in Review.

The government continues its aggressive investigation into FCPA violations in many sectors of the business world. News this week focused on settlements and investigations of companies ranging from Avon to Rockwell, and the pharma industry certainly has been no exception. This week Eli Lilly announced it was in advanced discussions with the SEC to resolve an investigation for alleged violations of the FCPA. The allegations center on activities at Lilly’s Poland subsidiary.

In a regulatory filing, SciClone said it would be delaying finalizing executive compensation until its internal investigation regarding FCPA compliance in sales and marketing matters in China is concluded. The company announced its internal investigation in November, and is cooperating with a parallel investigation by the SEC.

Pfizer joined Seimens, Telecor and Shell in a roundtable discussion in Thailand about governance and corruption. Pfizer’s representative, the Thailand and Indonesia country manager, said they strictly follow the FCPA. He pointed out that 80% of clients deal with the company in a straight forward manner. Employees are told to walk away from the other 20%. He also indicated that top management must take a lead in anti-corruption measures and not rely on regulation to prevent corruption.

In a land Down Under, GSK announced it would be releasing the overall payments made to physicians for consultancies, sponsorships and grants. GSK Australia country manager, Deborah Waterhouse, called this a first step. Indications are the end goal is to release this data at the physician level, as is required in the US.  Waterhouse said the company needs to understand the privacy implications of publishing the data at the physician level. She also said the move to release the information is part of a global initiative at GSK and that the company is committed to “enhancing the transparency of how we manage our business.”  While the announcement was commended by ethics experts, they said the information is of little value since individual doctors won’t be identified. There’s always at least one in every crowd isn’t there?

In the words of Princess Leia, (hey, it was Star Wars Day this week) “It’s a trap!” The “go-live” date for the Physician Payments Sunshine Act is quickly approaching, and companies are working to get processes in place to collect and report the required spend data. An article in Medical Marketing and Media poses the question: do companies need to re-work their policies involving transfer of value (TOV) items (meals, lodging etc.)? The article states the nearly perfect transparency created by the Sunshine Act is a potential trap for pharmaceutical companies who don’t address their TOV practices and policies. As this information becomes available, the fact that a company pays millions of dollars in meals to physicians will not sit well with the public, and will present a field day for the media. As evidence, the article cites the recent uproar over ProPublica’s compilation and publication of publically available spend data. Definitely food for thought.

Loose lips sink ships, and apparently they sink whistleblower suits as well. A whistleblower suit against Quest Diagnostics was dismissed this week on the grounds that one of the whistleblowers shared confidential information with the rest of the plaintiffs’ group. The individual in question is former general counsel at Unilab, the Quest subsidiary at the center of the False Claims suit. Lawyers for the whistleblowers argued that the disclosure of the information was a permitted exception since it prevented the commission of a crime. The judge disagreed, saying that revealing confidential information dating back to 1996 was beyond the scope of information the lawyer could have believed was necessary to prevent a crime in 2005. The dismissal does not preclude the government from taking on the case.

That’s it for now. If you’re attending the Society of Pharmaceutical and Biotech Trainers (SPBT) Annual Conference in Orlando, FL next week, stop by Booth 417 and say hi. We’d love to talk to you about how we can help you in training topics like FCPA, the federal False Claims Act and state disclosure laws with our eLearning solutions and iPad apps.

Oh, and Happy Mother’s Day to all you mom’s out there. Have a great weekend everyone!