Week in Review, March 16, 2012

The PharmaCertify™ Team

This has been a week of festivities, hasn’t it? Girl Scout’s Day (Happy 100th GSUSA), Pi Day, the kickoff, or maybe that is the tip-off, of March Madness, all culminating on Saturday with St. Patrick’s Day (we’re going to forget about the Ides of March)! At the News Week in Review, we’ll keep the party going and get you ready for the Wearing o’ the Green by keeping this week’s review festive and green! Time to get this party started.

Our first story comes from a country near the Emerald Isle, Scotland. A Scottish lawyer includes the pharmaceutical industry as one of the most prone to practices that can run afoul of the Bribery Act. The lawyer points to two bribery investigations underway in Scotland, and urged businesses to consider taking advantage of the Crown Office’s self-reporting program. Doing so puts the business in control of the process.

Moving on to an island that is sometimes described as a desert with green edges, a report reveals drug companies spent $40 million on physician education events in Australia in six months during the last year. The total represents an $8 million increase since 2008.

Consumer Reports is hoping for the luck of the Irish in its effort to organize the public to protest the 510(k) medical device approval process. The publication’s president, Jim Guest, sent an e-mail blast to one million people warning them that devices approved through the 510(k) process have never been safety tested in humans. The consumer advocacy arm of the magazine would not comment how much money it had allocated to the fight.

The proposed Sunshine regulations have not left medical organizations in a celebratory mood. The organizations are concerned physicians’ careers could be in jeopardy and their professional reputation damaged as a result of the rules. A number of medical societies have asked that physicians have more time to deal with information they feel is erroneous. They would also like to see changes to the way meals are allocated and reported.

The federal government has not always found gold at the end of the rainbow in  pursuing enforcement of the FCPA. Prosecutors have had trouble winning cases recently, with the shot-show sting case being the latest example of unsuccessful prosecutions. The US Chamber of Commerce and other organizations have decried the aggressive investigative and enforcement techniques the DOJ employs to pursue the cases but for its part, the DOJ is committed to pushing forward. Assistant US Attorney General, Lanny Breuer, says the US needs to be a leader in combating corruption, and he continues to grow his staff. The feds certainly have their work cut out for them, as the World Bank estimates that government officials are paid $1 trillion in bribes each year.

Being on the business end of an FCPA investigation sure can cost a company a big pot of gold. Investigations costs are on the rise, with many companies spending as much on the investigation as they spend on settlements. Even across the pond, the costs can be quite high, as indicated when News Corp. spent $104 million to deal with its 2011 phone hacking and corruption scandal.

We keep the anti-corruption party going with a story that raises the question of whether the Travel Act could be the Eli Manning of anti-corruption prosecutions. FCPA (the Travel Act’s big brother) prosecutions have taken some high profile hits lately, and the feds have showed “renewed interest” in the Travel Act. The Act is designed to combat racketeering overseas and gives the federal government more leeway in bribery cases. Unlike the FCPA, the Travel Act can be applied when the bribe occurs or is offered to someone other than a government official.

The FCPA isn’t the only area in which the DOJ has traveled a bit of a rough road lately. The effort to hold executives personally responsible when their companies are involved in cases dealing with healthcare law infractions has hit some hard times as well. At the beginning of the year, the government dropped charges against a Stryker sales manager and two other colleagues five days into a trial for illegal marketing. Charges were eventually dropped against a fourth individual in the same case. Last year, a judge dismissed obstruction charges against a former GSK lawyer, saying the lawyer never should have been charged, and it would be a “miscarriage of justice” for the case to go to a jury. Lawyers for the industry say the government needs to think about the evidence they have against individuals before they bring charges.

Moving on to action in the states, supporters of false claims act legislation in South Carolina may need the help of a four-leaf clover if they hope to have the legislation heard during the current legislative session. The AG’s office says the state missed out on $2.3 million for its Medicaid program since it does not have a false claims act on the books. Despite the potential monetary benefit, the state senator overseeing the committee reviewing all pending legislation says the calendar is crowded and the bill may not move this session. The story was different in the state of Washington, as the legislature approved the Medicaid False Claims Act in the waning hours of the legislative session. The law now moves to the governor’s desk for signature.

That brings us to the end of this week’s News. With anti-corruption continuing to trend to the top of the news, PharmaCertify’s eLearning course, Understanding and Preventing Bribery in the Global Life Sciences Marketplace, offers the updated content your global staff and third party representatives need to stay in compliance with the myriad of laws and regulations.

Have a wonderful and green weekend everyone!

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