Week in Review, April 8

The PharmaCertify™ Team

Team jersey…check. Foam finger…check. Mitt…check. The boys of summer are back, and here at the News Week in Review, we’re ready for some Cracker Jack fun! Granted, the opening day weather here felt better suited for football, but the start of the MLB season is a sure sign that spring is here! The smell of peanuts and fresh cut grass hangs thick in the air, but before we head off to the ballpark for the game, there’s a little business to take of first. Batter up! Play ball!

Stepping up to the plate first is news that the FBI plans to continue to use undercover techniques in FCPA cases. Despite the outcome of the “shot-show” FCPA trial, which turned on FBI undercover investigatory techniques, Ronald Hosko Assistant Director of the agency’s Criminal Investigations Division says,  “We’ll do it again…see you out there.” Hosko says that the FBI is working dozens of FCPA cases at any given time, and that branches throughout the US are involved in the investigations. Due to limited resources, he says the FBI only pursues cases with strong evidence, and if the agency pays you a visit you should assume there is a good why.

A Dow Jones survey of compliance professionals shows companies are digging in when it comes to their anti-corruption efforts (sub. req.). Seventy-one percent of respondents to the survey say they have delayed or stopped activities with business partners over concerns of breaking anti-corruption laws. More than half of the respondents say the FCPA and U.K. Bribery Act have had a major impact on policies, and 61% say the laws have impacted decisions about doing business in certain countries. The number of companies implementing an anti-corruption program rose to 87% from 83% in 2012. Confidence in due diligence processes took a dip though. While 56% of companies are “very confident” in their due diligence processes, the number that were “extremely confident” declined slightly to six percent.

Is it time to break out the celebratory wave? A new study of warning letters and notice of violation letters shows that social media may not be the regulatory nightmare it is generally thought to be. The digital communications consulting firm, Fleishmann-Hillard reviewed 173 letters sent between 2008 and 2012, and saw no increase in the proportion of social media violations versus traditional media. Company VP, Mark Senak, said guidance and violation letters are the two ways the FDA expresses policy, and there was nothing in regulatory enforcement to suggest that use of social media is riskier than traditional media.

In the social media game, Google is allowing the pharmaceutical industry an extra month to switch over to YouTube’s new One Channel format due to the regulatory issues faced by the industry. YouTube Channel clients are supposed to have their channels switched to the new format by May 15.

The replay review did not pay off for Pfizer. A federal appeals court ruled that the $142 million dollar verdict won by Kaiser Foundation Health Plan against the drug company stands. Kaiser said it was damaged when, based on fraudulent marketing by Pfizer, it prescribed Neurontin for a variety of conditions for which the drug proved ineffective. Additionally, the judges restored two similar lawsuits against Pfizer which had been thrown out by a lower court.

Speaker program budgets went on a downward slide in 2012 according to a new survey. The survey showed that while budgets for speaker programs declined an average of $500,000 in 2012, 60% percent of companies said they did not intend to reduce budgets for these programs in 2013. That cuts that are planned are substantial. For example, companies anticipating a cut to their speaker program budgets will slash 20-50%.

Well folks, we’re rounding third and heading for home on this week’s News Week in Review. We leave you with a reminder that PharmaCertify offers the custom and off-the-shelf solutions you need to ensure your team takes the field prepared with the most up-to-date compliance content.

Have a great week everyone!

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