Week in Review, Shiny, Happy New Year Edition

The PharmaCertify™ Team

Ah, the start of a new year! Are you feeling all resolution-y? Even if you don’t do the whole “New Year’s Resolution” thing, the start of the year just makes you feel recharged and excited about the future doesn’t it? We are certainly feeling recharged and ready to rip here, so without further delay, let’s kick off our first edition of the News Week in Review!

We’ll start with a story on a topic that never gets old – CME. It’s no secret that industry funding of CME has been on the decline over the last couple of years. A recent survey sought to ascertain if doctors noticed a change in quality of the programs and a quarter of the respondents reported that the quality has declined. A lack of authoritative speakers was cited by respondents as reason for the decline.

Covered entities under HIPAA may want to refresh their training and technology as we begin a new year. A recent study revealed a more than 30% increase in data breaches in 2011. In addition, over 90% of health institutions reported at least one data breach during the past two years. Throughout last year, there was a rise in legal enforcement involving data security as well as actions against individuals and institutions.

The orthopedics chair at the University of Wisconsin starts the year under fire for his ties to Medtronic. Reports say that since 2003, the doctor has been paid in excess of $25 million by the device maker. The doctor in question has also authored several papers favorable to the company’s spine products. The university’s dean defended the doctor, pointing out that he receives no royalties for spine products used at the University of Wisconsin hospital and noting the doctor was one of the most talented orthopedic surgeons in the world.

Instead of shedding pounds, Activs Inc. will be shedding $202 million this year in settlements with the U.S. and several states over charges the company inflated prices to government healthcare programs.

An appeal filed in a FCPA case will ask the courts to take a fresh look at the “foreign official” definition. The appeal comes from a man who was convicted and sentenced in October to seven years in prison for FCPA violations. The filling contends the court made a mistake in jury instructions regarding the definition of an instrumentality of a foreign government. This marks the first time a higher court will hear arguments on this issue.

Over in the now famous, second ‘shot-show trial,’ the defendants kicked off the New Year by asking the judge to declare a mistrial since the conspiracy charges under which they were originally joined were dismissed in December.

There was much excitement as 2011 wound down and the FDA released shiny, new draft guidance on the handling of unsolicited requests for off-label information. While it’s not the much-awaited guidance on social media, the new document did provide  minimal direction on social media in cases where off-label inquiries were involved. Peter Pitts says not to eschew what this document has to offer, and offers 10 lessons the industry can learn from the guidance. The information provided could be used as a jumping off point for the industry to lead the way in opening up communications with physicians and patients through social media.

Quite a bit going on during the first week of 2012 wouldn’t you say? With the release of the Sunshine rules and the new guidance on handling off-label inquiries closing out 2011, this year promises to be full of interesting twists and turns. Are you ready to give your training a new look as well? PharmaCertify’s customizable eLearning modules address the topics of day, like the Sunshine Act and state laws, on-label promotion and anti-corruption and our mobile apps deliver critical compliance content to your team when and where they need it the most – in the field and on the run.

As we wrap up this week’s News Week in Review, we close by congratulating Sir Andrew Witty, CEO of GlaxoSmithKline, on his knighthood. Pretty darn cool! Have a great weekend everyone and marvelous New Year!

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