Week in Review, January 21, 2014

The Serious Fraud Office adds Deferred Prosecution Agreements to its arsenal, doctors in the UK are looking for more transparency and one generic drug manufacturer gives up on China.

The teams for Super Bowl XLVII are set! The Seattle Seahawks and the Denver Broncos will do battle in New Jersey in February. Hmm, New Jersey…in February. Nothing against the Garden State (for many of us, it is home), but wouldn’t a warmer climate be more inviting for those with a ticket? Barring any blizzards, the game should be exciting as the top offense and top defense in the NFL face off. We know we’ll be tuned in, but until then there’s other news to address. Let’s kickoff this week’s News in Review.

February is shaping up to be a big month for the Serious Fraud office as well. Beginning next month, the SFO will be able to utilize Deferred Prosecution Agreements as a tool to deal with corporate bribery. The advantage to the SFO and to corporations is that agreements can be negotiated without prolonged court cases or the eventual debarment for corporations if they were found guilty through a trial. Implementing DPAs will bring its own set of challenges though. Judges in certain jurisdictions in the UK prefer justice to be doled out in court and not in advance. Consultation with judges prior to an agreement being signed should help, but the judges are not bound to accept the agreements. That leads to an issue of consistency in the process. If companies can’t rely on agreements being ratified by judges, they will be less likely to engage in the negotiations.

British doctors and academics teamed up to ask for more transparency in physician conflicts of interest. In an open letter appearing in the British Medical Journal, the group called on the General Medical Council to set up a general registry for physicians’ conflicts of interest. The letter cited an ABPI estimate that nearly 40 million pounds are paid to physicians by the pharmaceutical industry, and that the recipients of those payments are largely unknown. The letter said transparency into just who is receiving those payments “can only be good for medical practice.” A spokesperson from the GMC said that it could not require doctors to disclose payments without a change in law.

Generic drug maker Activis is scrapping its China playbook. The company announced it would cease operations in China. It’s CEO said China was not a “business friendly environment,” and there is too much risk in doing business there. The company has a small profile in China, and while it has not run into the issues some other pharmaceutical companies have of late, the CEO said he wasn’t confident that if anything did happen, the company would get a fair hearing.

2013 was another record setting year for False Claims Act recoveries, according to the DOJ. The DOJ collected $3.8 billion during the 2013 fiscal year. Of the $3.8 billion, $2.6 billion was from healthcare fraud recoveries. The majority of that $2.6 billion was from settlements with pharmaceutical industry companies.

Congress is calling for a review following CMS’ explanation for why payments for textbooks and journal reprints are not excluded from Sunshine reporting. The explanation provided by CMS did not sit well with members of Congress, and some are exploring options for changing the requirement. An aide to Maryland Representative Andrew Harris said the Congressman plans to add language to an appropriations bill to halt the collection of the data.

The fourth quarter’s here and it’s time to wrap this thing up. Before we dump the bucket of virtual sports drink over the head of this week’s Review though, we have to ask if you feel confident with your compliance training lineup for 2014. Do you need to add a new player or get back to training on the basics? The PharmaCertify™ suite of compliance training solutions includes two key players – Good Promotional Practices offers a comprehensive review of compliant product promotion practices and concepts for your sales team, and Commercial Compliance Overview is a comprehensive review of commercial compliance for your entire staff.

Have a great week everyone!

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