Week in Review, February 3, 2012

The PharmaCertify™ Team

It is almost here – the Sunday that we’ve all been waiting for since least September, if not this time last year. No doubt there will be excitement, laughter and maybe even a few tears shed as we gather around our television sets on Sunday evening to watch the best of the best compete for bragging rights. Yes, it’s finally time for Super Bowl commercials! And if you’re so inclined, there’s also a football game played in between these delightful bits of entertainment. While some in the PharmaCertify ranks are excited about that team with the NY on their helmets, the rest of us are once again left to mumble “maybe next year.”

In order to ‘warm up the audience’ as they say in the biz, we present our own delightful bit of entertainment and information, the PC News Week in Review.

We’ll kick off this week’s News with an op-ed regarding everyone’s favorite topic – the Sunshine Act. Written by a physician, the piece expresses a sentiment we rarely see in articles about the law; that is not likely to “have the purifying effect that its proponents promise” and not stop potential conflicts of interest from occurring. The author goes on to say the medical community is suffering from “over disclosure” as it is, and he wonders if anyone even pays attention anymore.

Could the Travel Act be the next player called off the bench in the government’s effort combat foreign bribery? Unlike the FCPA, the Travel Act addresses commercial bribery. So far, the regulation has only been used in a small number of cases involving foreign bribery, however the DOJ’s guide to the FCPA mentions the Travel Act as an alternative charge for bribery.

It was a tough week for prosecutors at the second Shot-show FCPA trial. First, the judge acquitted two defendants, leaving the fate of the three remaining defendants in the hands of the jury. After ten days of deliberation, the jury could not reach a unanimous decision, and the day after the acquittal, the judge declared a mistrial. For those keeping score at home, the government has now gone 0 for 2 in the prosecution of the individuals arrested through the government’s sting operation. There’s no indication as to whether the government will re-try this group of defendants.

The DOJ hosted a celebration to commemorate the 25th anniversary of the amended False Claims Act. The amended Act, which passed in 1986, strengthened the qui tam provision and provided incentives for whistleblowers. The celebration featured remarks from Attorney General Eric Holder and members of congress, as well as a panel discussion with experts from the government and the private sector. No news of any flashy touchdown dances or excessive celebration penalty flags being thrown.

This year, NBC raised the cost of a 30 second Super Bowl ad by 17 percent over last year. By comparison, the medical device industry will see a doubling of the fees it pays to the FDA for the next five years. The industry has agreed to pay the FDA $595 million in fees to help create a more efficient and consistent approval process.

The estimated cost of Super Bowl advertising may be going up, but what pharma is spending on DTC television advertising is going down. According to Nielsen, the industry has been on a downward trend since 2007. Between 2007 and 2011, the industry spent 23% less on television advertising. Analysts attribute the decline to the controversy surrounding DTC advertising and new generic competition against blockbuster drugs that are going off patent.

Upon further review from the officials, the U.S. government has decided to drop its case against a former president at Stryker. The charges stemmed from the company’s promotion of an unapproved use of two of its products in combination. With their client facing up to 20 years in prison for wire fraud, defense attorneys provided the government previously privileged documents that indicated their client had acted in good faith. Government attorneys reviewed the documents and decided to drop the case.

Before the final whistle blows, we’ll leave you with the news that GSK will settle 20,000 lawsuits related to Avandia. The settlement was the result of a court ordered mediation process.

That brings us to the end of this week’s News Week in Review. Whether you spend your Sunday watching the big game for the football or just the commercials, (or watching the new episode of Downton Abbey because it won’t be a repeat, unlike most shows that air during the Super Bowl), we hope you have a great weekend.

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