Week in Review, February 17, 2012

The PharmaCertify™ Team

Ah amore! Valentine’s Day was this past Tuesday and a day once dedicated to remembering the martyrs of the early Christian church, now is a celebration of love. According to the font of all knowledge, Wikipedia, we (and the greeting card and candy companies) can all thank Geoffrey Chaucer for associating the day with romantic love. You’d think having to read the Canterbury Tales, in olde English no less, in high school was the extent of the torture at Chaucer’s hands, but apparently not. Sorry. We’re really not jaded about love…just 14th century English literature.  We hope you and your sweetie had a lovely celebration (no need for details), and now we present our own little valentine…this week’s News Week in Review.

Attorney General Eric Holder and HHS Secretary Kathleen Sebelius released a report showing the government collected nearly $4.1 billion in recoveries from health care fraud and abuse during the last fiscal year (now, that’ll buy a lot of flowers and candy!). Of that total, pharmaceutical and medical device companies paid $1.3 billion in criminal fines, forfeitures, etc. for violations of the Food, Drug, and Cosmetics Act. The government also collected $2.4 billion through civil cases brought under the False Claims Act.

Hopefully, the Office of Civil Rights isn’t whispering “sweet nothings.” The agency announced it was setting a March target date for the release of the final version of HIPAA modifications and the HIPAA breach notification rule.

This ought to get your heart pumping – the FDA has requested a budget of $4.5 billion for fiscal year 2013. The budget represents a 17% increase over last year and the agency said forty percent of the budget will come from user fees. The drug and medical device user fees set to expire in October are expected to be renewed, and seven new fees will be approved, including the generic drug and biosimilar user fees.

Speaking of user fees, there was no love lost between consumer groups and the medical device industry at a U.S. House hearing on the medical device user fee. Medical device manufacturers would like to see the increased fees used for streamlining and speeding up device approvals. Consumer groups say device safety will suffer in the wake of faster approvals. Device industry advocates believe the days of the U.S. being the leader in medical device technology will be a thing of the past if the approval process is not improved.

Love hurts, or so the song goes, but could love hurt as much as debarment in the wake of an FCPA violation? A law professor and one of his students published an article in the Fordham Law Review arguing the time has come for the government to begin using debarment for FCPA violations. The FCPA does allow for debarment, but rarely does the government take that step when penalizing violators. The professor argues debarment would actually serve as a determent. He believe the fines currently levied in these cases represent a fraction of the money made in contracts gained illegally, and therefore monetary penalties do not serve as a deterrent to potential violators.

Instead of cards and candy, the U.K. Attorney General gave the Serious Fraud Office (SFO) an operations inquiry. The inquiry is to be conducted by the Crown Prosecution Services Inspectorate, and will include a review of how the SFO selects cases. The inquiry comes in the wake of high-ranking individuals leaving the SFO, and the organization dropping several high profile cases. The Attorney General’s office said the inquiry was not prompted by specific cases, and that the review had been under discussion for some time.

Democrat Senators Amy Klobuchar and Chris Coons sent a love note to Attorney General Eric Holder regarding the forthcoming guidance on the FCPA. The senators urged Mr. Holder to consult the business community when drafting the expected guidance on the FCPA, and asked that the guidance provide clarity and predictability for those affected by the regulation. To that end, the Senators asked for clear guidance on nine enforcement issues, including a definition of foreign official and the benefits that will be afforded companies who self-report and cooperate with investigations.

European life sciences companies are lovin’ life in the Sunshine. Well, maybe loving life is a bit of an overstatement, but according to a recent survey of European pharma, med device and biotech company executives, they are feeling more confident in their ability to meet transparency requirements in countries like France and the Netherlands. Survey results showed that compared to 2010, more companies are “enforcing corporate standards for spending on HCPs.” While there is greater confidence in companies’ abilities to meet transparency requirements, the survey showed respondents are concerned about data errors and data collection process inefficiencies.

That brings us to the end of this week’s News Week in Review. Now that you’re feeling all warm and fuzzy about Valentine’s Day, we’ll leave you with this warning – the FDA found 400 popular lipstick shades contained small amounts of lead, so make sure you check the list before you start smooching with your sweetie. On that happy note, we bid you a Happy Friday, and wish you a wonderful weekend. See you back here next Friday.

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