CME

Week in Review- October 22, 2012

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

The PharmaCertify™ Team

Now that it is mid-October, the time has come for glitter, glamour, kings and queens. Homecoming! The one game you have to win, and for ladies, the second most important dress you’ll buy that year (it isn’t the prom after all!). Oh, and let’s not forget, everyone loves a parade- except of course the people that are stuck behind the slow moving leviathan clogging up the streets of your town. For many of us it is a time to go back to our alma mater and see old friends, and remember the “good old days.” Let’s begin our own walk down memory lane with some of the news nuggets of yester-week. Now taking the field, this week’s News Week in Review.

Leading off the parade we have a story regarding the FCPA and the life sciences industry. Federal prosecutors and regulators have widened their expectations in third-party due diligence and the oversight that companies need to have over third-parties. The expectation is that companies not only do an initial due diligence, but also look at whether the third-party is capable of conducting business in a manner that measures up to the company’s own FCPA standards. For life sciences companies the sheer number of third-party relationships is staggering, and this need to review third-parties applies not only to new partnerships, but also to already established relationships. Implementing a sound assessment process that encompasses both new relationships as well as ones that are currently active is vitally important.

No more mum corsages for doctors in India from Abbott sales reps. Abbott has implemented a policy temporarily suspending the giving of gifts to doctors in that country. An internal memo says only clinical or scientific literature may be given. The ban even includes minimal value “therapy reminder” items such as pens. Indian law prohibits doctors from accepting gifts or travel, however the law is not consistently enforced. No comment from Abbott as to the reasoning for the decision. In other Abbott news, its $1.5 billion settlement agreement for off-label promotion of an anti-seizure medication was accepted by a judge in federal court.

Are doctors not showing enough spirit for the results of studies funded by the industry? According to one doctor, the skepticism pendulum may have swung too far.  Physicians have become skeptical of the results reported in pharma funded studies as pointed out in a study published in the NEJM. Some skepticism is warranted, but as the doctor points out, physicians have gotten so skeptical that they could be overlooking important safety data by discounting pharma sponsored studies. He suggests that there needs to be more transparency in clinical studies, and suggests greater third-party statistical review and more use of public access sites like clinicaltrials.gov.

The Sunshine Act: the industry’s current homecoming queen. She sure is taking her time putting on her crown and sash to meet the public. While we all wait on the final rule, take a listen to this podcast (written transcript here) from Medsider that discusses the law and its impact on medical device manufacturers. (Much of what is discussed is applicable to those outside of med device as well.) In the podcast the Medsider host and his guest expert discuss a variety of issues including: the purpose of the law, the costs associated with preparing to implement the law, are there any loopholes in the law and what companies need to be doing now to get ready to implement the law. An important point made by the guest is that if companies do not have front-end policies and procedures in place regarding physician consulting agreements, they should seize the opportunity to do this now before their data is publically available. While Sunshine does not require any of this, he says both the government and private attorneys will likely be pouring over the information in the public database. He likens just having your back-end systems and processes in place without addressing this front-end issue to driving a car without car insurance. Nice.

Massachusetts med students want the governor to revisit the past in regards to the provision of meals. A group of med students and consumer advocates, carrying trays of champagne and lobster tails (seriously?), delivered a petition asking the governor to bring back the ban on providing meals at educational presentations outside of a practitioner’s office. The group believes the definition of a “modest meal” is vague, and that these meals do nothing to benefit patients. The group would like to see Massachusetts’ Department of Health set a dollar limit on these meals, ban the serving of alcohol and obtain information about how money for these meals is allocated.

That brings us to the end of this week’s review, but before we put away the crepe paper and streamers we’d like to float one more thing by you: mobile learning. Access is everything, so why not make sure your ethics and compliance training accessible for your learners on their terms? PharmaCertify has a variety of mobile learning solutions to help you put compliance knowledge in the hands of people when and where they need it.

That brings us to the end of the homecoming celebration. We hope you had a good time reminiscing with us. Have a great week and we’ll see you back here next week!

News Week in Review, October 1, 2012

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The PharmaCertify™ Team

The weather has cooled, fall sports are in full swing, and the World Series is just around the corner. Then there’s that one additional reminder of the change of season: a new television season is upon us. Goodbye to the repeats and summer reality, and hello cliffhanger resolutions! We still have more premieres on the way, but for now we’d like to entertain you with  this week’s News Week in Review.

We begin our broadcast day with the news that Stryker has agreed to pay $1.5 million in legal fees to settle two shareholder suits. Stryker admitted no wrongdoing as a part of the settlement, but did agree to install a committee aimed at preventing violations of the FCPA and False Claims Act, and illegal promotional activities.

Lawmakers and the industry are asking the Administration to end the delay and implement the final rule for the Sunshine Act. Senator Herbert Kohl calls the delay unacceptable. Senator Grassley did not mince words, saying efforts to communicate with CMS had been met with resistance, and it was “[as if] Congress passing a law doesn’t make a difference in this town.” Tune in next week for the continuing drama on “Waiting on Sunshine.”

A Modern Family probably has at least one person who owns a smart phone, and a congressional representative from California plans to introduce a bill aimed to smooth the FDA’s evaluation process of apps for those phones. The bill, if passed, would establish an Office of Mobile Health at the FDA to provide recommendations on issues related to mobile apps and to support developers trying to understand regulations related to privacy. IT industry groups and developers are on board with the formation of the new office as an attempt to foster innovation while protecting patients.

A White House advisory group may have been feeling a little Grimm about the rate at which new drugs are being approved, so a plan was drafted to double the rate of approvals. The plan calls for faster approvals of drugs for high risk patients. The advisory group urged the FDA to use its “accelerated approval” process with more frequency to approve drugs for targeted patient populations. Patient and physician group representatives have praised the plan, saying it protects the public health while giving patients in high-risk situations access to medicine.

Once Upon a Time, Assistant Attorney General Lanny Breuer said the DOJ intended to release new, detailed guidance on the FCPA. Now it seems the promised guidance will be delivered in the next few weeks. (Ahem…CMS…take note) The guidance is expected to be released in advance of the October 10 Organization for Economic and Co-operation and Development meeting. In an interview with Compliance Week, the FCPA Professor, Mike Koehler, says he doesn’t expect there to be anything “groundbreaking” in the new guidance, but it is likely to address newer issues that were not addressed in the previous guidance.

Are Board members Persons of Interest in a corporate bribery investigation? A new survey of BOD members reveals one-third believe bribery is their company’s greatest fraud risk, while 63% believe their personal liability has gone up over the last three years. Two-thirds of those surveyed indicated their company did business overseas, with nearly 60% of those indicating they did business with foreign officials. According the Corporate Fraud Index latest quarterly report, reports of corporate fraud, including those concerning violations of the FCPA and UK Bribery Act, represent 23% of all compliance reports.

It’s Elementary that pharmaceutical and medical device industries face risks when it comes to bribery and doing business in other countries and now someone has created a list of the top five corruption risks. Spoiler Alert! The top risks are: state-owned healthcare enterprises, third-party agents, sponsorship of medical conferences, foreign clinical trials, and “anything of value.” As enforcement agencies focus more on the life sciences industry, training on the risks of doing business outside the U.S. has become even more critical. We can help with the customizable Understanding and Preventing Bribery in the Global Life Sciences Marketplace eLearning module.

Well that rounds out this week’s “broadcast.” Before we sign off, there is one more piece of “news” to bring you. While turning thirty is a milestone that is often looked upon with trepidation, that is certainly not the case in central Florida today, as the fine folks at the Walt Disney World Resort celebrate the 30th anniversary of EPCOT. Congratulations to our friends at “Spaceship Earth!”

Have a great week everyone!

Week in Review, September 24, 2012

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The PharmaCertify™ Team

Well, fall officially arrived on Saturday! Bring on the rich colors, cooler weather, outdoor festivals and fairs, and perhaps most importantly, the end of the growing season for lawns most every where.  If none of this inspires you for the turn of season, perhaps last week’s revival of Starbuck’s Pumpkin Latte will do the trick. As you take time to enjoy this beautiful time of year, don’t forget to schedule a few minutes to check in on the compliance news of the past week, with the News in Review.

Winds of change are blowing slowly in Australia. Medicines Australia’s revised Code of Conduct currently sits with a government regulatory agency awaiting approval. The change under consideration is the reporting of monies paid to physicians for speaking and consulting services, including payments for travel and hospitality while providing those services. If the change is implemented, reports will be published beginning mid-2014. Not everyone is happy. Transparency advocates would like to see individual payments reported, not aggregate payments.

Staying in the South Pacific (where it isn’t fall at all), the Penang Health Department is investigating six pharmaceutical advertising claims involving products for heart and kidney diseases. An enforcement representative said none of the ads received the required regulatory approvals.

Moving on to a cooler climate, a compliance professional in Russia explains what “compliance” means to the Russian pharmaceutical industry. He explains that a successful compliance program is not just about making sure your company is following the “rules” as defined by government agencies, but also involves the proper flow of information. A company needs to have systems that allow the information to flow from the compliance team and back from the organization.

A new study finds that physicians have a skeptical view of clinical trials sponsored by industry. Board certified internists were provided abstracts of results for clinical trials for fake drugs. The physicians were informed that the funding for the studies came from either the industry or the NIH, or there was no disclosure at all. Participants were then asked to offer their confidence in the results of the study and whether they’d prescribe the drug. Products related to those studies identified as funded by industry were less than half as likely to be prescribed as those funded by the NIH.

In corporate fraud cases, whistleblowers can definitely rake in the big cash, but the big dollar awards are rare, according to experts. That’s because most cases involve multiple whistleblowers, and the awards are split among the group. Then the relators’ lawyers and Uncle Sam take their cut. Across all industries, five of the top seven awards went to whistleblowers in healthcare cases. Three of those five are from pharma cases: Pfizer, GSK and Abbott. To keep your team reporting to the compliance office instead of their lawyers’ offices, PharmaCertify’s off-the-shelf compliance modules include topics like open door and anti-retaliation policies and are easily customized to include your hotline and contact information.

A new study finds that 25% of pharmaceutical companies do not have dedicated compliance teams in place. (Color us a bit shocked.) According to the researchers, many of the companies believe that compliance needs to be decentralized in order to be in better contact with the issues “on the ground” so they tasked “function-specific personnel with compliance responsibilities.”   Unfortunately, that approach has resulted in business units being unaware of what other units are doing in terms of compliance polices and processes. The researchers recommend that one individual be assigned to oversee all the company’s compliance efforts, and to draw a line between regulatory and commercial compliance responsibilities.

And with that, we come to the end of this week’s NWR. Enjoy the fall weather everyone and have a great week!

Week in Review, September 17

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The PharmaCertify™ Team

It starts earlier every season, and before long, you’re sick and tired and just ready for all the hype to end. “Christmas sales?” you ask. No. (Although the fact there are trees up and decorated in stores before we’ve even brought out our fall clothes is disturbing.) We’re talking about campaign season. We’ve had enough of all the posturing, the non-answer answers, the ridiculous campaign and PAC ads that run more often than beer ads during a ball game. There should be some sort of rule, law or generally accepted practice that there is to be no campaigning by candidates, or thought provoking messages by PACs, more than six months prior to the first primary! Okay, we’ll step off the soapbox now and move on to news you can actually use: this week’s News Week in Review.

We’ll lead off the NWR with a politician attempting to hold the bureaucracy accountable. Senator Chuck Grassley issued a statement regarding the current status of the Sunshine Act during a roundtable session of the Senate Special Committee on Aging. After some brief background regarding the Act, Senator Grassley expressed his frustration with CMS’s continued delay in releasing the final rule for Sunshine, and their lack of communication regarding the reason for the delay. He even brought up the rumor that CMS has sent the final rule to the Office of Management and Budget (OMB), and the OMB is holding up releasing the rule until after the election. He called on CMS to confirm whether there is any truth to the rumor, and if there is to clear up why the rule is being held. Grassley closed his comments by defending the companies that will have to implement the law by saying companies need the final rule released to assure their systems would allow them to meet the “letter of the law.”

From the halls of the Capitol comes the shocking story that fighting over budget cuts by our elected officials now threatens to hold up the dollars paid in user fees by drug and device makers. In order for the FDA to access the money paid by the industry, it must first receive certain funding from Congress, and the budget stalemate in Congress is delaying that funding.

In news from the FDA, the Office of Prescription Drug Promotion (OPDP) issued an untitled letter to Eli Lilly questioning the use of color on an image of a brain that appeared  on a product website and on promotional materials. The OPDO said Lilly was misbranding the product, a radioactive agent used for PET Scans, because the color images suggest that scans can be displayed and reviewed in color. The prescribing information specifically calls for the use of black and white scale and gives several examples of how to read scans in black and white.

On the political history front, the DOJ has re-released the original FCPA document signed by President Carter and Speaker of the House, Tip O’Neal. A nice slice of history, but what isn’t history is the DOJ’s focus on investigating healthcare companies for potential violations of the law. The medical device industry has found itself squarely in that bull’s eye. An article in Compliance Week examines recent settlements and the risks that make the industry vulnerable to potential violations. The author says the top factor regulators take into consideration during investigations and settlements is a strong culture of compliance within an organization. Robust training is an important part of building a culture of compliance, and we can help with our Understanding and Preventing Bribery in the Global Life Sciences Marketplace module.

Hey, look who’s jumping on the Pinterest bandwagon; it’s pharma! A handful of companies are embracing this rapidly expanding social media platform. Bayer was the first to “pin it,” and now, they’ve been joined by Boehringer Ingelheim and GE Healthcare.

BI also upped the social media game for the industry with the beta launch of its Facebook game, Syrum. The game allows players to run their own pharmaceutical company and develop drugs for a variety of diseases. The company also has a YouTube channel, Twitter feed, and blog focused on the game. The game is in public beta in Europe, with a global launch expected in 2013. We can’t wait to see the FB requests for lab equipment appear in our news feed.

For an executive at a pharma or med device company, being excluded from federal healthcare programs is never a good career move. So the former CEO of InterMune is fighting his five-year exclusion handed down last year. The CEO claims that since his wire fraud conviction had nothing to do with delivering a health care item or service, the OIG had no basis for exclusion. He claims the OIG based the exclusion an unproven allegation of misbranding, for which he was acquitted. The OIG says the CEO is misinterpreting the law, and that a direct correlation between the conviction and the provision of a health care item or service is not required.

That certainly was a big week for political mudslinging, but we’ve hosed off and we’re hoping to evade the muck this week. Oh well, that’s what they make volume buttons for, right? On the bright side, we are one week closer to the election, so it will all be over soon. We can take some comfort in the fact that this sort of craziness has been around since well, since a political system existed in this country. If you think political races of modern times are harsh, take a look at some old school mudslinging.

Have a great week everyone!

Week in Review, September 4, 2012

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

The PharmaCertify™ Team

At last, this past weekend was the time to dust off the pompoms and break out the stadium seats! Fall “officially” arrived with the start of the college football season! This is truly the most wonderful time of the year! Decorating the car with magnets and flags, preparing a game day feast for family and friends, and let us not forget the ever important ritual of face and body painting. Good times, good times. After such festivities and a long holiday weekend, it’s hard to focus and get back to work, but we’re here to help kick off this first work week of fall with the News Week in Review.

We’ll kickoff this week’s review with a story of kickbacks. Omincare has struck an agreement in principle in a whistleblower suit that accuses the company, and its owner, of paying kickbacks when it purchased a pharmacy services company. The government declined to join the suit. Omincare has agreed to settle the suit, but the company’s owner has not, and that case continues.

Pharmaceutical sales reps in India haven’t exactly been cheerleaders for their industry, as made obvious by the day-long strike by the Federation of Medical and Sales Representatives’ Associations of India. The group protested against threats to job security, high prices of drugs and corporate corruption in the industry. In a letter, the FMRAI said the effort to shift responsibility for corporate corruption onto sales representatives has led to reps being banned from hospitals and medical institutions. The group says the true corruption is occurring at the corporate level and it is demanding that a statutory code of ethics be enacted.

And now for the halftime show! Taking the field is the American College of Informatimusicology with their salute to obtaining your medical information. Sit back, relax and enjoy the show!

The California Assembly passed a bill that will amend the state’s False Claims Act. The amendment will more closely align California’s law with the federal statute. Changes in the California law include increased protections for whistleblowers, provisions for awards to relators even if those relators were involved in the action that led to a violation, increased penalties for violations, and broadening of the definition of what constitutes a claim. The bill has been sent to the governor for signature.

The much anticipated FCPA guidance from the government appears to be advancing down the field ahead of schedule. Assistant Attorney General Lanny Breuer had said the guidance would be released in November, but now sources say the government will release the guidance in advance of the OECD meeting in October. The release could come this month with the officials from the Justice Department scheduled to speak about the guidance at the National Conference on the FCPA.

Some Georgia men may find themselves wearing a black and white striped uniform, but it won’t be as referees. The Securities and Exchange Commission charged eight men with insider trading related to Sanofi-Aventis buying publically traded Chattem, a pharmaceutical products company. The SEC says one of the men, an accountant, learned of the pending sale from a client who had come to him to discuss the tax implications the Chattem purchase would have on his stock options. The accountant then shared the information with four friends and as the cliché goes, “they told two friends, and they told two friends, and so on, and so on.”  The SEC said the group made just over $500,000 in trades. Four of the accused have agreed to settlements with the government without admitting wrongdoing. Cases against the other four men are moving forward.

Well folks, the clock has run down on this game, and all that’s left is to tune up the band and sing the Alma Mater before we head out of the stadium. We hope your team, high school or college, emerged victorious over the holiday weekend! Have a great, short, work week everyone.

Week in Review, August 20, 2012

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The PharmaCertify™ Team

It’s that time of year again. It’s the season when we’re inundated with television commercials compelling us to wait in long lines for the latest must-have items. It’s back to school time! And we have a reading assignment for you…this week’s News Week in Review. The bell is about to ring, pencils out please.

Medicines Australia is starting the school year with a group project: determine the best way to publically disclose information about payments to doctors. The organization’s Working Group on Transparency is comprised of members of the medical community, consumer groups and pharmaceutical companies. While Medicines Australia has stated its commitment to improving transparency of physician payments, the Australian Medical Association is concerned about the identification of individual doctors. Their concerns echo those that have been raised by medical groups here in the U.S. about the Sunshine Act, including the potential for misrepresentation of the data to the public.

The DOJ appears to be cutting back the amount of “school supplies” it requires of companies accused of FCPA violations. During 2012, the DOJ pulled back on the requirement that companies hire an independent monitor. Only three of seven companies have been required to hire the monitor thus far this year. The others have been asked to self-monitor and then report to the DOJ. In recent years, the problems with the independent monitors have been a source of embarrassment for the Department, and that may be the reason for the cut back. While we’re on the FCPA, check out this list of the top 10 corporate settlements. Guess what industry did not make the list?

A new study finds doctors are more likely to move sales reps carrying iPads to the head of the class.  According to the study, 65% percent of doctors say when they’ve seen reps carrying an iPad. More importantly, 35% of doctors say they are more likely to request a sample from a rep that is carrying an iPad, and 29% say they are more likely to prescribe.

We’ve reached the lunch portion of our “school day.”  If your beverage of choice is chocolate milk made with Hershey’s syrup, it may not be as nutritious as the label led you to believe. The FDA issued a warning letter to the chocolatier regarding wording on the labels of a couple of the syrups. One product said “plus calcium” and another used the wording “fortified with vitamins and minerals.” Neither product met the guidelines necessary to make those claims. The company has since changed the labels.

Vein treatment device maker, Vascular Solutions, seems to have gotten on the class monitor’s list. The company has announced the federal government will intervene in an off-label investigation. The investigation stems from a complaint filed with the U.s Attorney’s office alleging the company’s promotional practices cost the government around $20 million in damages. The company said it will continue to cooperate with the U.S. Attorney’s investigation, but will defend the case “as something that’s factually inaccurate and without merit.”

PhRMA, AdvaMed, Biotechnology Industry Organization (BIO) and Medical Imaging and Technology Alliance (MITA) teamed up on a letter writing assignment this week. The industry trade groups sent a letter to CMS this week regarding the pending final rules for the Sunshine Act.  The groups expressed their appreciation to CMS for their careful consideration of the many comments received on the proposed rules and requested CMS allow manufacturers 180 days to implement the final rule before beginning data collection.

Speaking of AdvaMed, a gold star goes to the group for its hiring program for returning military veterans. The program is called MedTech Veterans Program Boot Camp for Returning Heroes, and it will provide training in resume building and interviewing skills. Additionally, 25 vets will be provided mentors to help them transfer their skills into jobs in the med tech sector.

The bell is about to ring, so time to pack up and head to the next class. For those of you who are still on “summer vacation,” enjoy the final beach weekends before you’re rockin’ the school’s carpool line. Have a great week everyone!

Week in Review, August 3, 2012

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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

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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!