compliance

Week in Review, August 3, 2012

NXLevel Compliance Team , , , , , , , , , , , ,

The PharmaCertify™ Team

A tropical storm is churning in the Atlantic, the summer Olympics are going strong and the temperature is steaming hot. Yes, summer is in full swing, but over the weekend the first glimmer of fall appeared! The NFL kicked off its pre-season with a game between the Cards and the Saints. Relief from the heat is on the horizon! You could practically feel the crisp air and see the falling leaves. While there was only one game this past weekend, the rest of the league will be in action soon, so you still have time to dig that foam finger or team towel out of storage. Before you do though, take a gander at the week that was. Down, set, hike! Here we go.

Let’s kick off this week with news of pharma and med device advertising going digital. A publisher of medical journals and texts says advertisers are moving to digital platforms. Why… because that is where the doctors are. Use of iPads by medical professionals is on the rise. Medical journal publisher, Wolters Kluwer, has commitments from 50 companies, including several top pharmaceutical and medical device companies, to advertise in a digital format. To encourage companies to adapt their ads, the company no longer offers the option to purchase print only ad space and instead they bundle print and digital ad space. As it turns out, more time is spent viewing journal ads through apps than through traditional print. Several manufacturers are also incorporating video in their ads.

Pay-for-delay deals are facing a possible judicial sack on both sides of the Atlantic. Here in the US, the Third Circuit Court for Appeals issued a decision that such arrangements are anti-competitive. The Federal Trade Commission has been critical of pay-for-delay deals, and a spokesman for the FTC said the decision by the court was a step in the right direction in “solving this very real problem.” Both generic and branded drug makers argue that the deals are simply a way for solving patent disputes. Across the pond, the European Commission has brought the first anti-trust case against a drug maker for a pay-for-delay deal. A Danish drug company is accused of violating EU anti-trust laws through deals with generic companies that delay the entry of a generic competitor for as much as two years. The Commission says the drug maker may have caused consumer harm through its deals. The company refutes the charges and says its practices are compliant with both EU and national competition laws.

Olympus, the world’s largest maker of endoscopes, is calling a penalty on itself…well a potential penalty. The company discovered “irregularities” in a doctor training program in Brazil and has reported the matter to the DOJ. The company says a violation of the FCPA may have occurred. According to Olympus, the issue springs from the way the company may have handled expenses for travel, food and entertainment for doctors. The DOJ is also looking into the company’s marketing in the US.

Over at Bayer in the UK, there’s been an acknowledgement of a breach of the ABPI Code. Apparently, an employee created and distributed drug information without the company’s knowledge. Three documents were that had not been through the company’s review process were distributed. Some of the volatile material in the documents included comparative claims, inaccurate data, lack of fair balance, and the discussion of license uses. In all, the company has admitted to 12 breaches of the Code.

Vermont has not moved the ball forward in quelling pharmaceutical spending in the state. Despite the transparency brought by the state’s disclosure law and the banning of gifts, pharmaceutical companies have continued to spend at pre-law levels. With changes in the statute, the collected data can be difficult to compare, but according to the state’s Attorney General’s office, the level of spending has been roughly the same the law was passed.

Like the summer, the clock is ticking down on this week’s Review. We hope everyone locates their tailgating essentials in preparation for the weekend’s games. It may still be a bit warm to enjoy our tailgating favorite, chili, but a few burgers and dogs on the grill and an ice cold beverage should hit the spot. Have a great week everyone!

Week in Review, July 27, 2012

NXLevel Compliance Team , , , , , ,

The PharmaCertify™ Team

The majestic tones of the trumpet and pomp of the kettle drum of the Olympic theme rang out on tellies across the world this past weekend with the launch of the 30th Olympiad in London. As exciting as all the sporting contests are, nothing was probably more anticipated than the opening ceremonies. Other than the few carefully leaked bits of information, the majority of the details were shrouded in the mists of Brigadoon. So when the veil of mist finally parted, what did you think? What was your favorite part? We’d give it to the parachuting “Queen”. So, with that in mind, Mr. Bean and the Chariots of Fire sequence wins the night (honorable mention to the bicycling doves.) With opening ceremonies over though, it is time to get down to the business of competing, and this week’s News Week in Review.

Our first story takes us to the 2016 Olympic host country of Brazil. The legislature there has again delayed a vote on the country’s proposed anti-bribery law. However, compliance professionals and others are not waiting on the vote to pass and are getting ready for the law now. According to the OECD, Brazil was the number four country receiving direct foreign investment in 2011. That trend is only expected to rise. Additionally the country will be hosting two key international sporting events in the very near future; the soccer (or football) World Cup in 2014 and the Olympics in 2016. These events will bring a flood of direct and indirect investment into the country. The country is expected to spend billions to make infrastructure improvements to prepare for both of these events. Construction and sports are typically fertile grounds for bribery to occur. As it stands now, the proposed law is built on two pillars: the tough sanctions for violators and incentives for companies to act ethically and comply with the proposed law. It is expected the law will be passed in 2013.

But, back to our current host city of London. Reports are that many high dollar tickets have remained unsold (hmmm…last minute trip anyone?). Could this be due to company restrictions on personal gift giving and receiving? A recent survey from the Society of Corporate Compliance and Ethics (SCCE) and the Healthcare Compliance Association (HCCA) suggests this could be contributing factor. The survey from the two groups showed that most companies are pretty restrictive of the gifts employees can give or receive. The survey found that more companies ban the giving of gifts by employees than receiving. Non-profits and healthcare were tops in banning the giving of gifts. Entertainment also is restricted, but more companies restrict the receiving entertainment than the provision of entertainment. Again healthcare led the way in restricting entertainment over other industries.

The FCPA professor passed the torch to some guest authors this week, three of the defense counselors involved in the first trial in the FCPA sting case. The three attorneys represented a UK citizen in the first group of defendants. They believe there were two overarching factors which led to the results of the first trial and the eventual failure of the prosecution: 1- the pre-trial exclusion of evidence of previous bad acts and 2- their unorthodox decision to call the government’s lead investigator as their only witness.  In the first factor the lawyers said the government intended to bring in seven examples of prior bad acts. They argued this would lead to confusion, and in the case of their client, if he had actually participated in these bad acts, it was not evidence that he intended to defraud the U.S. or violate the FCPA. The judge agreed, and the evidence was not permitted in trial.  In calling the government’s lead investigator as their only witness the lawyers admit they took a huge risk. However, it became clear to them that the government did not intend to have him or their key informant as witnesses. The team took the tactic to ask government witnesses about who made the key strategic decision regarding the investigation. When witnesses answered with the name of the lead investigator, it opened the door for the defense to call him as a witness to answer questions about the investigation. They were then able to illustrate the flaws in the government’s investigation. The resulting mistrial in the first case led the government to change its strategy for the second case.

If you do business with the government, the last thing you want to take a tumble on is a violation of the False Claims Act (FCA). With hefty penalties and treble damages not to mention the specter of exclusion all on the table for violations, companies have to take care to assure they do not run afoul of this piece of legislation. In 2009 and 2010 there were six significant amendments to the FCA brought around by passage of the Fraud Enforcement and Recovery Act and the Patient Protection and Affordable Care Act.  These six amendments are: the Anti-kickback liability; public disclosure and original source requirement; expansion of liability for overpayments; reverse false claims; elimination of the presentment requirement; expansion of the term “claim.”

Industry grants for CME took another dive in 2011. Industry support has been waning since 2008. According to the ACCME industry funding dropped by 11.4% in 2011. The money collected from ads and exhibits fees from industry did go up in 2011, but unlike the previous year, the revenue from these sources was not enough to keep CME in the black. The number of providers and overall attendance also declined in 2011.

The former President of R&D at Pfizer, John LaMattina, has an interesting suggestion in the wake of the loosening of restrictions in the Massachusetts gift ban. Bring the doctors to the researchers. Mr. LaMattina points out that while the charge to loosen the restrictions on meal provisions to doctors was led by Massachusetts Restaurant Association, pharma was not doing itself any favors by joining in. Public perception is that these meals are meant to entice doctors into prescribing expensive drugs, and by the industry arguing for the restrictions to be repealed, it was not doing anything to enhance its public image. LaMattina believes there is true value in physicians and industry representative communicating, but that perhaps there is a better venue in which the communication can occur. His suggestion is for companies to bring the doctors to the labs. In Massachusetts many large companies have research facilities. He points out doctors are very interested in the science behind the drugs, and in turn, the scientists at these facilities enjoy talking about their work. This makes the R&D facilities a great spot for companies and physicians to discuss products and exchange ideas.  What do you think? Gold medal idea, or false start?

That brings us to the end of this week’s News Week in Review. We hope you’ve enjoyed the weekend of competition. We sure have, and after Kazakhstan’s victory in the cycling road race, we’re sure Borat is pretty stoked as well. Have a great week everyone, and go Team!