The PharmaCertify™ Team

Spring officially arrived this week. Of course for many of us around the US, we’ve been enjoying spring-like weather for a while now (so much for that groundhog being right). If you live south of the Mason Dixon line, you may have had the additional seasonal joy of a chartreuse haze in the air. It’s record high pollen. Pollen so thick it coats everything in sight, as well as the inside of your nose and throat. Don’t know about you folks, but right about now we are wishing we had stock in the makers of allergy meds! Enough about the business of sneezing, let’s get down to business of this week’s compliance news.

We’ll start this week’s review off with a couple of stories from the medical device sector. Senator Kelly Ayotte of New Hampshire told med-tech companies in the state she is committed to repealing the medical device tax that is due to be implemented in 2013 as part of the healthcare reform act. Some experts say implementing the tax will be more complex than most companies are expecting.

Later this spring, Scotland will implement new regulations preventing companies linked to individuals convicted of bribery from bidding on public contracts. Two existing sets of regulations will be updated to include new offenses created by the Bribery Act and Scotland’s Criminal Justice and Licensing Act 2010. The new regulations will go into effect May 1.

Excitement may be blooming in England for this summer’s Olympics in London, however, corporate hospitality packages are selling slowly due to concerns over the Bribery Act. A representative of the firm providing official legal services for the games said clients are asking if they can bring guests, to which he replies yes. However, he suggests that companies scrutinize the reasons for inviting guests, not invite guests for whom there may be sensitive contract issues pending, and keep a log of all guests and the reasons why they were invited. The SFO has indicated they will be watching to see if companies are offering extended hotel stays and free travel for friends or family of guests.

There are calls from Australia and Canada for public disclosure of the green the industry spends on physicians. In Australia, a former GP says that company sponsorship of a physician’s medical conference attendance should be put to an end. And, an upcoming review of Medicines Australia’s Code of Practice by the country’s Competition and Consumer Commission has prompted some companies to suggest it’s time to move away from hosting physicians’ attendance at conferences. In Canada, a former pain specialist calls on the government to pass legislation similar to the Sunshine Act. He believes physicians have become indifferent to the influence industry funding has on the practice of medicine.

Every FCPA action brought in 2011 involved bribery by third-party business partners, and FCPA regulators are paying more attention to the research that companies conduct on their third-party partners. Despite the risk, a recent poll found companies are only scratching the surface when it comes to due diligence and risk assessment of third-parties. 30% of the respondents said they worked with 1,000 or more third-party partners and just over 20% said they performed due diligence and risk assessment on only about a quarter of their third-party partners. 5% said they did no due diligence at all. Cost of implementation was the top reason cited.

Itching to create a successful whistleblower program? Look no further than the SEC whistleblower program created under the Frank-Dodd Act, or the whistleblower provisions in the US False Claims Act, for examples. According to an article in Forbes, there are seven keys to a successful program and topping the list is the need for mandatory monetary rewards for the whistleblowers. Other suggestions include provisions for back-pay or reinstatement if the whistleblower is fired, and encouraging whistleblowers to first report issues through their company’s internal program.

We’ll wrap up this week’s news with two stories from the state of Oregon. First, Pfizer agreed to pay $3.3 million to the state to settle an investigation into illegal marketing practices of an antibiotic. According to the state’s department of justice, the company used flawed clinical trial study information to claim its product was superior to another antibiotic available as a generic. Pfizer denied any wrongdoing in the matter. In the second story, the Oregon Health and Science University is set to review its policies on outside income for its researchers in response to scrutiny on the influence of industry funding. The University has convened a task force comprised of staff, students and administrators to review the policies and discuss where improvements are needed.

It was touch and go, but we made it to the end of this week’s News Week in Review without sneezing all over the keyboard (okay, we admit, that was gross). For those suffering from pollen-induced allergies, we hope the weekend brings some rain and relief. For those of you missing out on the chartreuse nightmare, just think, you’ll have fewer people in line in front of you for tickets to The Hunger Games.  Have a great and sneeze-free weekend everyone!