Week In Review, November 11, 2011

The PharmaCertify™ Team

Today is 11-11-11 and the superstitious among us are scurrying about getting married or at least buying lottery tickets. Today is also the last binary day, a date in which no digit exceeds one, (as long as you don’t write out the full year) of the century. And we even have a little joke to celebrate the day: There are 10 kinds of people – those who understand binary and those who don’t.

Most importantly though today is Veteran’s Day (or Armistice Day if you like to roll old school). Before you head out to your local parade or other celebration, we give you this week’s PC News Week in Review.

Last week we discussed Senator Grassley’s displeasure with CMS’s delay in releasing  the Sunshine Act guidelines. This week we get news that CMS says it will most likely be spring of 2012 before the rules are issued. Wow. Let’s hope they mean early spring. Silver lining: at least we have a date, however nebulous.

Not to be outdone, Leon Rodriguez, the new head of the Office of Civil Rights, testified before a Senate subcommittee chaired by Al Franken of Minnesota about a long delayed privacy and security regulatory update mandated by the HITECH Act of HIPAA. The new chief would not offer a timeline for when the long overdue rules could be expected. This did not sit well with Sen. Franken, who said that electronic health records offered a great opportunity to improve efficiency in healthcare, but those benefits would not be realized until patients could be assured their records would be kept private. Don’t let it get you down though Mr. Rodriguez. Just repeat the wise counsel of Stuart Smalley; “I’m good enough. I’m smart enough, and doggone it, people like me.”

Where oh where has my disclosure report gone? Or, where should it go as the case may be in West Virginia. A rule change has caused the governor-elect to withdraw the rules enforcing the state’s disclosure law. The hubbub appears to center on a 2010 modification that changed how and to what agency the reports are submitted. Umm…okay. Moving along…In Pennsylvania, a proposed False Claims Act for the state sits in committee waiting approval. (Go ahead and sing it; we know you want to. “I’m just a bill, yes, I’m only a bill, and I’m sitting here on Capitol Hill). Wrapping up state-based news, the Congressional delegation from Minnesota has signed a letter urging the FDA to streamline the approval process for medical devices.

Over in the UK, Richard Alderman, the director of the Serious Fraud Office (SFO), has confirmed there is Bribery Act enforcement activity occurring in the office. The SFO is working directly with corporations, and as such, much of the information regarding the cases will remain private for the time being. Mr. Alderman said the office is investigating complicated cases, and not just going after the low-hanging fruit.

In China, the former chief executive of a government-owned pharmaceutical company found guilty of embezzlement and accepting bribes was handed a suspended death sentence, with a two year reprieve. The former CEO is said to have collected around $8 million through corrupt means. Suddenly, that 15 year sentence handed down for FCPA violations a few weeks ago doesn’t seem quite so bad.

And speaking of the FCPA, the DOJ announced that it would release new guidance on FCPA civil and criminal enforcement provisions. The new guidance will be released some time next year.

Ethics and compliance has gone from “geek” to chic. (We always knew it was chic!) The head of the Society of Corporate Compliance and Ethics (SCCE) said that companies are taking a new view of ethics and compliance programs and are growing their departments. He says he has seen an increase in membership in the SCCE, and compliance jobs are among the fastest growing in the country. As Huey Lewis said so may years ago, “It’s hip to be square.”

That brings us to the end of this week’s review. We’d like to end this week’s review by saying thank you to our veterans. It is your sacrifice that allows us to remain safe here at home, and go happily about our day writing fun little articles summarizing the news of the week in the world of pharmaceutical and medical device compliance. May God bless you all.

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