The PharmaCertify™ Team

This past Sunday marked the last drive, walk and face slap on Wisteria Lane.  Desperate Housewives ended its 8 year run, and finally it all makes sense why Mary Alice narrated more seasons of the show than her family’s storyline allowed. Where will we turn for our weekly dose of murder, adultery and backstabbing among neighbors? Hmmm…perhaps this new show called Dallas. It starts next month. Oh well, until then we’ll all just have to make do with real life. Truth is stranger than fiction, right? Let’s find out in this week’s News Week in Review.

The early part of the week brought the unsealing of a whistleblower suit with juicy details alleging that Medtronic installed a surgeon as an editor for a prominent spinal journal to make sure favorable articles about one its products were published. The suit also claims the surgeon allowed authors of the articles to hide their financial ties to the company, and that he did not disclose that he profited from the use of the products. Then a few days later, in a twist worthy of any prime time soap opera, the DOJ announced that it had closed its four year investigation of the company. No charges were issued and no settlement reached.

It’s good news over at the Abbott house. The company closed out a 1999 consent decree with the FDA. The original decree was issued over manufacturing problems at it diagnostic unit.

Everyone’s favorite neighbor, Sen. Charles Grassley, has expressed his disappointment at CMS for postponing the collection of physician spend data required under the Affordable Care Act. The Senator says CMS needs to get the implementation of the law right, and with this new delay, they have no excuse to not get it right. The big question is when will the first reports be due? As of now the March 31, 2013 date still stands. I guess we’ll all have to stay tuned to see how this cliffhanger resolves itself.

The ladies of Wisteria Lane are nothing if not trendy. We like to keep it trendy too, and it seems the big trend in healthcare law enforcement is the enforcement of both state and the federal False Claims Acts. Federal and state enforcement agencies have committed substantial resources to the pursuit of healthcare fraud this year. That trend is likely to continue as recoveries rise and the states become more active in pursuing violations against their own laws, outside of federal efforts.

And speaking of enforcement trends, what about anti-bribery? Much has been made of the DOJ’s commitment to pursuing possible violations of the FCPA, and it has been nearly a year since the UK Bribery Act “went live.” More countries are now passing laws prohibiting the bribery of government officials, foreign officials and bribery in the private sector. Enforcement agencies in various countries are cooperating with each other and fines are rising around globe so this won’t be one trend that is here today and gone tomorrow.

Donald Trump is ready for a fight and he says the FCPA should be overturned. On CNBC’s Squawk Box, the Donald said businesses shouldn’t be prosecuted for going overseas and following the practices and customs of other countries. He went on to say keeping other countries honest shouldn’t be the job of the United States. If those countries want to prosecute bribery, let them do it.

The latest bribery scandal on the block, Wal-Mart, has raised questions about the value of self-disclosure. For its part, Wal-Mart did not disclose its findings of bribery until the 11^th hour. Lawyers say in certain situations, bribery involving a member of senior management for example, self-disclosure is generally recommended.

Well, that’s is for another week of drama in this crazy compliance world of ours. Sometimes, truth really is stranger than fiction. As the storylines continue to evolve, we’ll keep you apprised of all the juicy details right here at the News in Review and through our daily Twitter feed. Have a great weekend everyone!

The PharmaCertify™ Team

Can you believe it is mid-May already? It’s the time of year for weekly release of blockbuster films. Last week’s contribution, Avengers, broke all box office records and we’re just one week in to the summer movie season. However, there is a bit of business to which we must attend before we head out the door to wait in line for this weekend’s premieres: this week’s News Week in Review. It promises to thrill, chill and offer laughs a plenty. All you could want, right? Lights… electrons…read!

The blockbuster news item of the week was the announcement of the federal government’s settlement with Abbott for $1.5 billion, to resolve a criminal and civil investigation into the illegal promotion of the drug, Depakote. The company pleaded guilty to a misdemeanor of misbranding the drug under the FDCA and paid $700 million in criminal fines and forfeiture. According to the government, Abbott promoted the drug for the off-label uses of treating aggression and agitation in dementia patients and for schizophrenia. The drug is approved to treat epileptic seizures, bipolar mania and migraines. Additionally, the company agreed to pay $800 million in civil fines for alleged violations of the False Claims Act and the Anti-kickback Statute. Of the $800 million, about $240 million will go to the states. The whistleblowers in the case will share an $84 million dollar payout, which is the second highest FCA-related payout since the law was revised in 1986.

Like any good blockbuster, there must be a sequel. And in the case of the Abbott settlement it was the litany of stories released from the Attorney Generals’ offices in the states receiving a piece of the settlement. So for your entertainment here’s just a preview of Settlement II, the States Strike Back: Tennessee, Arkansas, Oregon, Iowa and Rhode Island.

What would the summer movie season be without a story of corporate and government intrigue?  A House of Representatives committee widened its investigation into the deal struck between the West Wing and the pharma industry to support the administration’s healthcare reform efforts. Initially, the Republicans on the House Energy and Commerce committee contacted an industry trade group demanding to see documents related to the deal. When that failed, the committee went to drug companies directly to demand documents about the negotiations. At first, the group targeted Pfizer, but the inquiry has widened to include other companies like AstraZeneca, Amgen and Merck.

This week, the Senate green lighted an investigation into the relationship between manufacturers of narcotic pain meds and patient pain advocacy groups. The senate panel is interested in records about the links, financial and otherwise, between the industry and the groups that advocate the use of their products. The panel requested payment information for the past ten years from three drug manufacturers, five patient pain groups, the Joint Commission and the Federation of State Medical Boards. The interest in the relationship comes amid a growing concern about the overprescribing and abuse of narcotic pain killers. Media reports suggest the industry may be responsible, in part, for misuse due to the misrepresentation of the benefits and dangers of the drugs.

A happy ending appears to be on the horizon for the credibility of journal articles on industry sponsored clinical research.  A group representing industry and publishers made 10 recommendations for closing the credibility gap in reports of industry sponsored clinical research. The group says authors and publishers need to employ best practices and clearly communicate the standards and requirements of the studies in order to enhance transparency and credibility. A professor at York University in Canada claims that while the recommendations are a good start, they may have no affect on the problem. Citing non-emphatic language, and some weak recommendations, the professor said there is evidence to show a study funded by industry is more likely to have a positive outcome for the company sponsoring the study. He recommends clinicians consider this bias before applying the study results in their work.

Well we’re about to call it a wrap on this edition of the News Week in Review and this work week. But no blockbuster would be complete without some shameless product placement, so here it is: this week’s top story demonstrates that off-label promotion remains a crucial remains a focus for investigation. Pharmacertify offers a series of customizable off-the-shelf training modules and iPad apps to help integrate an awareness of on-label promotional policies into your staffs’ consciousness. You can learn more and even see a “trailer” at www.pharmacertify.com.

That’s a wrap folks! Cut, check the gate, print, weekend!

The PharmaCertify™ Team

Big news folks! In fact, we’re going to dispense with our usual set up of the News Week in Review, and just get right down to business. We’re sure you will be as shocked as we were when we tell you CMS has pushed back the starting date for collecting physician spend data to January 1, 2013. On the CMS blog, the agency stated that it received over 300 responses during the comment period for the proposed rules for implementation of the Sunshine Act. They also say they would like to give due consideration to the feedback provided during the comment period, and therefore is pushing back the date that data collection is to begin. While not providing a date, the agency says it expects to publish final rules later this year. If we hadn’t bet all our money on Bodemeister to take the Kentucky Derby, we’d be ready to place best on what “later this year” actually means. How about you dear readers? Think we’ll see those rules before Halloween, or will we get another almost Christmas surprise?

Is there anything else worth discussing beyond CMS and the lack of Sunshine regulations? Well actually yes there is. You know how we love a good bribery story, and everyone’s favorite retailer has definitely corned the market in the world of foreign bribery lately. Thomas Fox says the Wal-Mart scandal effectively ends businesses’ push for FCPA reform. The level of the scandal at the company’s Bentonville offices will make the U.S. Chamber of Commerce’s argument for change quite challenging.

On the legal front, Par and the DOJ say they are optimistic a resolution can be reached in the current investigation into the company’s marketing of a drug that treats AIDS-related weight loss. Motions were filed this week asking for a 60-day stay of pending litigation.

There is a good bit of news involving the UK Bribery Act this week. First, the Organization for Economic Cooperation and Development (OECD) issued its review of the Act. The OECD acknowledged that the U.K. had made strides in fighting bribery with the legislation, but the organization does have concerns with several points in the Act. Their concerns include: lack of public information about the settlements, an increase in civil recovery orders (a less transparent process than criminal pleas), and the potential for the SFO to enter into confidentiality agreements, which prevents key information about bribery from being released to the public.

Next we have the results of a survey conducted by Ernst and Young that found only one in four middle managers felt the Bribery Act hurt Britain’s competitiveness. While the results do not paint a completely dire picture of businesses attitude toward the Act, it isn’t completely rosy. Of the respondents that were actually familiar with requirements of the Act, only 30% percent believed Britain’s ability to be competitive would not be harmed by its implementation.

Lawyers specializing in bribery and fraud warn that regulators are stepping up their enforcement of the Bribery Act. New Serious Fraud Office chief, David Green, issued a number of uncompromising messages during his first week in office. In addition, U.K. financial regulators have issued a flurry of guidance about anti-bribery controls. Businesses holding off on putting processes into place until the first big prosecution happens may want to rethink that strategy.

Finally, we take it back to where we started, the Sunshine Act. Michael Loucks and Alexandra Gorman ask the question “who regulates the regulators?” in a blistering opinion piece for Forbes. Loucks and Gorman specifically point to the issue of HHS requiring that payments associated with OTC drugs and Class I medical devices be reported under the Sunshine Act. They claim this is in direct conflict with Congress’ intent for the Sunshine provisions in the healthcare reform law and the requirements will result in higher costs for drug and device manufacturers.

Well gang, we’re off to pick up some mint leaves for the juleps and to grab fixins for some hot browns. Have a great weekend and “may the [horse racing] odds be ever in your favor.”

The PharmaCertify™ Team

Polish up your tiara and grab your glass slippers – it’s National Princess Week!  The princesses among us here at the News Week in Review are looking forward to a weekend of lavish luxuries, but first we must tend to our responsibilities about the castle. So cue the royal trumpeters…by royal proclamation, we proudly present the News Week in Review.

Following last week’s publication of a study showing 11% of Canadian prescriptions are written off-label, the Globe and Mail published an editorial calling for Health Canada to track off-label use of drugs. Citing information from the study that only one in five of drugs prescribed off-label has any scientific evidence to support its use, the publication asserted that patients and doctors need more education about the use of certain medications. They have called for the creation of a computerized system listing drugs and the conditions they are effective in treating.

Over in England, where they have real princesses, off-label prescribing could be sent to the dungeon. The General Medicines Council (GMC) has changed plans to ease the restrictions on off-label prescribing. Currently GPs may prescribe a drug off-label if it better serves the patient’s needs over the licensed drug. The GMC is reviewing whether the current restriction is in conflict with a European law.

Apparently, a certain princess doesn’t need quite as much help from Prince Charming these days. Typically, the federal government (Prince Charming) does the heavy lifting when it comes to investigating and prosecuting pharmaceutical companies for violations of healthcare law and regulations. However, the state of Oregon (our princess) recently struck its own settlement with Pfizer over false and misleading advertising of Zyvox. The settlement requires Pfizer pay the state just over $3M, not promote Zyvox in a false and misleading manner, disclose various payments and transfers of value, and post Zyvox clinical trial results to ClincalTrials.gov. Oregon participated in the government’s investigation of Pfizer over off-label promotion of Zyvox and Bextra. Will more princesses follow Oregon’s lead?

Is the clock about to strike midnight on the Massachusetts gift ban to doctors? Consumer groups certainly hope not, and say that if current effort to repeal the gift ban is successful, it will cost the state $750M (that is one expensive pumpkin!) in increased drug costs over the next ten years.  The repeal would also allow pharma companies to provide prescription coupons to consumers. Opponents say this would drive consumers to use more expensive drugs when cheaper generics are available, costing the state and consumers more in the long run. Supporters say the coupons offer patients more options, and help toward what can be expensive co-pays for drugs that are on that patient’s insurance company formulary.

Sometimes riding off into the Sun(shine)set isn’t always the path to your “happily ever after.” At least that’s the way doctors are feeling about the payment disclosures required by the Sunshine Act. A Massachusetts nurse practitioner who serves on a pharmaceutical company’s speakers bureau says participating in the programs is a catch-22. She is passionate about teaching other healthcare professionals, but she is concerned that patients may think she is “on the take” because of the payments. The NP says she and most healthcare professionals who speak on behalf of pharma companies simply want to help patients by educating their peers, but she understands that some are in it for the money. Physician groups and pharma are concerned that the regulations, as currently written, do not clearly explain the nature of the payments. A representative of PhRMA says patients need to understand that just because their doctor has received a payment from a pharma company, it does not mean the doctor “has been compromised.”

And so we close this proclamation of compliance-related industry news for the week. Our fairy godmother is standing by, with our chariot at the ready, so we bid you all a weekend filled with a little sparkle and a lot of magic. Bippity, boppity, bye!

The PharmaCertify™ Team

There’s a certain chill in the air…a shudder of fear and trepidation that is sweeping through the nation. No, it is not that today is Friday the 13^th, but that tax day looms before us this weekend. Oh, the paper cuts from receipts, oh the hours spent with a calculator, oh the humanity of if all! Okay maybe that’s a bit much, but tax day is just around the corner on April 17^th. We certainly hope you will be sitting back laughing, or feeling pity, for those whose weekend will be spent hunched over a desk diligently working to make the deadline. And if you need a little something to read when you take a break from the 1040s and the line items, we present this week’s News Week in Review?

How long of an “extension” are Senators Grassley and Kohl willing to give CMS to finalize the rules for the Sunshine Act? Only a few more months, according to a letter the Senators sent the acting head of CMS. In the letter, the senators expressed their disappointment (again) that the regulations were not completed by the deadline specified in the law, and demanded (make that “asked”) if CMS could have the regulations ready by the summer. They also asked if the Agency had ramped up its staff and allocated the funds needed to implement the Act. The letter included a request for a response by April 18^th. Stay tuned.

Let the receipt collecting begin! Finance experts for the healthcare industry suggest that hospitals begin collecting information from physicians now about their financial relationships with industry, rather than wait to see how the final regulations shake out for the Sunshine Act. That includes understanding how the information will be perceived by the public. According to one finance expert, there is no down side in the hospital having this information on file now, and as long as all the relationships are on the level, there is no downside for the physician.

Repealing the medical device tax is high on Senator Scott Brown’s list. The topic was a top agenda item during the Senator’s recent visit to three Massachusetts device manufacturers.  Brown says he became aware of the tax when campaigning for his seat back in 2010. His concern is that the tax will lead to a loss of jobs, and negatively impact the economy of the communities that surround the manufacturing facilities. Brown has introduced a bill to repeal the tax, and he encourages device manufacturers to communicate their concerns to their congressional representatives.

No more deductions, revisions or other changes are needed as the FDA has delivered final guidance on agency and medical device industry guidelines for requests for information and applicable user fees. The requests for information, known as 513(g) requests, are generally for device classification, and a user fee is imposed for facilitation. The fees for the 2012 calendar year range from $1,700 to $3,400.

HHS recently handed down the first civil penalties for violations reported under HITECH’s breach notification rule. As part of the Resolution Agreement, Blue Cross Blue Shield of Tennessee (BCBST) agreed to pay $1.5 million in penalties and enter into a Corrective Action Program. BCBST self-reported the theft of 57 hard drives containing the PHI of one million people. The hard drives were left in a network data closet in a building BCBST no longer occupied. The CAP will require BCBST to create policies and procedures addressing risk assessment, risk management and physical security. The company must also increase training and monitoring of its HIPAA policies.

A former VP of sales for a medical device company brought a taxing situation to an end by pleading guilty to violating the Anti-kickback Statute. He faces up to five years in prison and $250,000 in fines and forfeiture. The government claimed the man established a sham consulting agreement with a NY surgeon in order to induce the surgeon to use his company’s bone growth stimulator. The surgeon never actually performed any consulting services for the company. When he became concerned about government scrutiny about such arrangements, the former VP and a territory manager worked with the surgeon to backdate time sheets to make it seem as if the consulting work had happened. Sentencing is set for July.

That brings us to the end of this week’s News Week in Review, and the end of our distraction from completing those lovely tax forms. We hope your Friday is full of good luck. We end with congratulations to Eli Lily CEO, John Lechleiter, who has been named the new chairman of PhRMA.

Have a great and un-taxing weekend everyone!

The PharmaCertify™ Team

Bright colors, green grass and the search for small round objects await us this weekend. Yes, it is that time of year again folks; its Master’s time, golf’s storied event. Where legends are made, and the greatest of the great find themselves brought to their knees by the course’s challenging twists, turns and temptations. Joy and disappointment played out before us all in the pursuit to be the owner of what has to be one of the ugliest pieces of clothing in professional sports…the coveted green jacket. Well we’re all pretty excited for this year’s tournament, but before we stake out our spot somewhere in Amen Corner to watch the spectacle, we have a little bit of business to take care of here, this week’s News Wweek in Review.

Pharma, AdvaMed and BIO are concerned with the FDA’s current lie on its guidance for handling unsolicited requests for off-label information. Comments submitted to the FDA by the three industry groups were generally supportive of the guidance’s objectives, but each had concerns with some aspects of the document. All three groups were concerned with the FDA’s handling, or lack thereof, of oral requests for information. The groups say treating oral requests as written requests is not practical, and creates a burden that is not in the interest of the public health or scientific discussion. PhRMA and AdvaMed also said the FDA needs to provide specific guidance on the use of social media. AdvaMed made the point that companies should be allowed to respond in a timely manner with truthful, non-misleading information online, rather than just through traditional off-line methods.

Next we’ll shoot over the water hazard known as the Atlantic Ocean, to Britain, where a group representing various healthcare and life sciences organizations came together to create a set of guidelines for working with the pharmaceutical industry. The group, known as the Ethical Standards in Health and Life Sciences Group, hopes to forge a collaborative partnership with the pharmaceutical industry in order to better patient’s lives. A statement of best practices was created and signed by organizations involved with the group. The document describes the current environment in which healthcare providers and the pharmaceutical industry operate, and rules by which each will abide as they interact.

Certain Asian countries may need to consider teeing up new local anti-corruption laws. Singapore, a country that has traditionally been tough on corruption, has found itself dropping from the number one position to the number five position on Transparency International’s Corruption Perceptions Index. It may be time for Singapore, and other countries in Asia, to take a page from the UK Bribery Act and address not only bribery of government officials, but also corporate bribery.

The FDA could be guilty of slow play where medical device approvals are concerned, according to a report from the General Accounting Office. The GAO report says the FDA is technically meeting its approval time lines for 510(k) devices, but that time line stops when the FDA asks a manufacturer to provide more information. When the time that occupies that process is factored in, device approvals timelines have increased from 100 days in 2005 to 161 days in 2010.

A federal judge gave a former sales representative permission to play through on her wrongful termination lawsuit. The former rep questioned her training that she claims encouraged the promotion of a heart device for an off-label purpose. She questioned the legality of what she was being asked to do during training, and was reprimanded. The rep continued to raise concerns that the off-label promotion could violate the False-Claims Act, at which point her employer then invented reasons to fire her, according to her argument.

Well we’ve approached the 18^th fairway and are heading for the green of the weekend. We hope you all have a wonderful weekend, and remember…see the ball, be the ball.

The PharmaCertify™ Team

Is it the end of March already?! This first quarter of the year has flown by hasn’t it? Well with the end of March also comes the end of March Madness. The final games in the NCAA basketball tournament will be played this weekend in the Big Easy. How have your brackets held up? If they haven’t done well, you can always take your chances with the $500+ million Mega Ball drawing this weekend. Okay, time to put the dreams of scoring big aside, and get back to the real world; this week’s News Week in Review.

The Massachusetts Restaurant Association is hoping a new bill in the Massachusetts legislature will get them back in the game of hosting meals between pharma companies and physicians. Massachusetts legislature’s small business and community development committee signed off on a bill which would allow meals to be provided to physicians in restaurants. The Massachusetts House of Representatives has been supportive of such measures in the past, but the Senate has been more resistant. The CEO of the restaurant organization says restaurants are suffering due to the ban, and he hopes legislators will see the job creation benefits of passing the bill.

Seems the drug sample possession arrow is pointing toward pharmaceutical companies rather than doctors’ offices. The number of samples left by sales reps is down 25% since 2007. The reduction is largely due to the cut back in the sales force numbers and the fact that many offices are refusing to take samples. According to a survey, 23% of physicians’ offices do not accept drug samples.

The OIG and forty-two industry compliance professionals met at center court in February to discuss a number of compliance issues facing the pharmaceutical industry. Industry attendees at the meeting were all from companies currently under a CIA, and as you might imagine a top topic was the challenge in implementing CIAs. Other topics on the agenda included: compliance program structure and oversight; risk assessment and monitoring activities; policies, procedures and training activities; and compliance post-CIA. As the meeting wrapped up, industry participants noted a number of changes which would pose challenges for the future such as regulatory changes (ex. Sunshine Act), social media and lack of regulatory guidance in that area, and a changing business model in the industry.

Speaking of social media, the industry may essentially be on the sidelines when it comes to participating in social media, but a recent survey suggests companies are getting into the game of using social media for market research. Survey respondents predicted their companies would be using social media for market research in the coming year. At the Pharmaceutical Marketing Research Group National Convention, companies already engaged in this practice said listening to patients through social media outlets helped them shape clinical trials and product messaging. In addition, this type of research can have an advantage over more traditional market research methods in that companies have more than one shot at gaining patient feedback.

Just when we all thought the final buzzer had sounded on the FCPA sting case, more news emerged this week. Government prosecutors petitioned the court to have the convictions dismissed of three of the defendants who previously pleaded guilty to conspiracy charges in the case. Charges were dismissed against 16 other defendants still facing prosecution when the government decided not to proceed further with the case. The dismissal did not apply to the three defendants who had already pled guilty. The government said the dismissal of charges should also apply to these three defendants.

On the settlement front, Biomet Inc. entered into a Deferred Prosecution Agreement with the DOJ to resolve charges of improper payments under the FCPA. The company will pay $17.8 million in criminal penalties, and in agreement with the SEC, another $5.4 million in disgorgement of profits. Cypress Pharmaceuticals, its subsidiary Hawthorn Pharmaceuticals, and its CEO have agreed to pay $2.8 million to resolve allegations the company violated the False Claims Act. The government alleged the company promoted several products that had not been designated “safe and effective” by the FDA. The company promoted the drugs in this manner to physicians which  resulted in improper payments by state Medicaid programs and the military’s TRICARE program.

Well the game clock is dwindling down, and the weekend buzzer is about to sound. We hope yours is full of fun and excitement. If your plans involve watching the NCAA Tournament, consider a chocolate bunny as your game time snack. Apparently chocolate is good for the metabolism among other things. Now that, is truly news you can use!

Have a good one everyone!

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!

The PharmaCertify™ Team

This has been a week of festivities, hasn’t it? Girl Scout’s Day (Happy 100^th GSUSA), Pi Day, the kickoff, or maybe that is the tip-off, of March Madness, all culminating on Saturday with St. Patrick’s Day (we’re going to forget about the Ides of March)! At the News Week in Review, we’ll keep the party going and get you ready for the Wearing o’ the Green by keeping this week’s review festive and green! Time to get this party started.

Our first story comes from a country near the Emerald Isle, Scotland. A Scottish lawyer includes the pharmaceutical industry as one of the most prone to practices that can run afoul of the Bribery Act. The lawyer points to two bribery investigations underway in Scotland, and urged businesses to consider taking advantage of the Crown Office’s self-reporting program. Doing so puts the business in control of the process.

Moving on to an island that is sometimes described as a desert with green edges, a report reveals drug companies spent $40 million on physician education events in Australia in six months during the last year. The total represents an $8 million increase since 2008.

Consumer Reports is hoping for the luck of the Irish in its effort to organize the public to protest the 510(k) medical device approval process. The publication’s president, Jim Guest, sent an e-mail blast to one million people warning them that devices approved through the 510(k) process have never been safety tested in humans. The consumer advocacy arm of the magazine would not comment how much money it had allocated to the fight.

The proposed Sunshine regulations have not left medical organizations in a celebratory mood. The organizations are concerned physicians’ careers could be in jeopardy and their professional reputation damaged as a result of the rules. A number of medical societies have asked that physicians have more time to deal with information they feel is erroneous. They would also like to see changes to the way meals are allocated and reported.

The federal government has not always found gold at the end of the rainbow in  pursuing enforcement of the FCPA. Prosecutors have had trouble winning cases recently, with the shot-show sting case being the latest example of unsuccessful prosecutions. The US Chamber of Commerce and other organizations have decried the aggressive investigative and enforcement techniques the DOJ employs to pursue the cases but for its part, the DOJ is committed to pushing forward. Assistant US Attorney General, Lanny Breuer, says the US needs to be a leader in combating corruption, and he continues to grow his staff. The feds certainly have their work cut out for them, as the World Bank estimates that government officials are paid $1 trillion in bribes each year.

Being on the business end of an FCPA investigation sure can cost a company a big pot of gold. Investigations costs are on the rise, with many companies spending as much on the investigation as they spend on settlements. Even across the pond, the costs can be quite high, as indicated when News Corp. spent $104 million to deal with its 2011 phone hacking and corruption scandal.

We keep the anti-corruption party going with a story that raises the question of whether the Travel Act could be the Eli Manning of anti-corruption prosecutions. FCPA (the Travel Act’s big brother) prosecutions have taken some high profile hits lately, and the feds have showed “renewed interest” in the Travel Act. The Act is designed to combat racketeering overseas and gives the federal government more leeway in bribery cases. Unlike the FCPA, the Travel Act can be applied when the bribe occurs or is offered to someone other than a government official.

The FCPA isn’t the only area in which the DOJ has traveled a bit of a rough road lately. The effort to hold executives personally responsible when their companies are involved in cases dealing with healthcare law infractions has hit some hard times as well. At the beginning of the year, the government dropped charges against a Stryker sales manager and two other colleagues five days into a trial for illegal marketing. Charges were eventually dropped against a fourth individual in the same case. Last year, a judge dismissed obstruction charges against a former GSK lawyer, saying the lawyer never should have been charged, and it would be a “miscarriage of justice” for the case to go to a jury. Lawyers for the industry say the government needs to think about the evidence they have against individuals before they bring charges.

Moving on to action in the states, supporters of false claims act legislation in South Carolina may need the help of a four-leaf clover if they hope to have the legislation heard during the current legislative session. The AG’s office says the state missed out on $2.3 million for its Medicaid program since it does not have a false claims act on the books. Despite the potential monetary benefit, the state senator overseeing the committee reviewing all pending legislation says the calendar is crowded and the bill may not move this session. The story was different in the state of Washington, as the legislature approved the Medicaid False Claims Act in the waning hours of the legislative session. The law now moves to the governor’s desk for signature.

That brings us to the end of this week’s News. With anti-corruption continuing to trend to the top of the news, PharmaCertify’s eLearning course, Understanding and Preventing Bribery in the Global Life Sciences Marketplace, offers the updated content your global staff and third party representatives need to stay in compliance with the myriad of laws and regulations.

Have a wonderful and green weekend everyone!