Week in Review, September 4, 2012

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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 27, 2012

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The PharmaCertify™ Team

Time is a ticking on summer with Labor Day just around the corner and now is the time to squeeze in those final cookouts and road trips. Of course, any proper barbecue or cross country trip wouldn’t be complete without a list of great summer tunes. Remember that great anthem that you heard all summer long and brought back great memories when you heard it years later? Well, as you start building this year’s Labor Day weekend playlist of guilty pleasures, we have a bit of “list” to tune up ourselves, the News Week in Review.

There’s been a British invasion over at Shire as the company joins the Association of the British Pharmaceutical Industry (ABPI) as a full member. Regarding the decision, company representatives said, “we seek to play a role in the development and growth of our industry, so joining the ABPI will be one way of contributing to this.”  Shire will also have a representative joining the ABPI Board of Management.

Two congressmen are not singing the praises of the current 510(k) approval process for medical devices. In a letter to the head of the FDA’s Center for Devices and Radiological Health, the pair expressed concern that faulty medical devices are able to reach the market through a loophole in the 510(k) approval process. The congressmen would like to see the FDA’s authority extended to deny approval for devices with designs that are based on devices that have previously been recalled.

On the legal front, former baseball star, Eddie Murray, and Abbott executive, James Mazzo, were indicted by the SEC on charges of insider trading related to the purchase of Advance Medical Optics by Abbott. Mr. Mazzo, former CEO of Advance Medical Optics, is alleged to have shared non-public information regarding the sale with one of Murray’s teammates. Murray learned of the sale from the teammate and profited from the inside information. Mr. Mazzo denies the allegations while Mr. Murray has agreed to a settlement with the SEC, but has denied any wrongdoing.

A former employee at Abbott is whistling an interesting tune about the company’s marketing practices for its cholesterol drug, TriCor. A new whistleblower case has been filed alleging the company used misleading and off-label marketing practices and provided kickbacks to doctors, which all led to Medicare and Medicaid paying for unnecessary prescriptions.

The definition of a foreign official under the FCPA, an oldie but goodie, was making the rounds on the anti-bribery playlist last week. This time, the case involves a Haitian telecommunications company. One of challenges to the defendants’ conviction centers on whether Haiti Teleco could be considered an instrumentality of the government simply because Haiti’s national bank owned a majority of shares in the company. In its brief, the government said 97% of the telecom company is owned by the bank, thereby making it an instrumentality of the government. The government also said the defendants could have requested an opinion from the DOJ as to whether the telecom company counted as an instrumentality.

Boehringer Ingelheim wants to “blind you with science,” but not in the typical fashion. Rather than announcing a breakthrough drug, the company announced they launch a social game that lets players run their own lab. The game, Syrum, is scheduled for beta trial in September. The company says they developed the game to educate “players about the pharmaceutical industry in a fun and engaging way.”  Game on!

And so we’ve reached the end of our playlist. If you’re like us, you’ll soon be breaking out the seersucker suit and white shoes for one final spin as you relish the memories of another summer season? Have a great week everyone. Enjoy the Labor Day festivities!

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 13, 2012

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The PharmaCertify™ Team

The thrill of victory, (US Women’s soccer team), the agony of defeat (Aly Raisman and Catalina Ponor both finding themselves out of a bronze medal due to gymnastics’ tie break rules) as well as the human drama of athletic competition (Oscar Pistorius and the first Saudi female athletes), has played out in London as the Olympics came to a close this weekend. And shockingly it ended without an overload of Miley Cyrus’ “Party in the USA” from the broadcast team at NBC. Something to be thankful for! Now it is time to return to the grind. If you’ve been glued to your computer for the around the clock, live stream, we’ve got your back with the News Week in Review.

In the Olympic spirit, an international group of researchers conducted a study regarding the disclosure of conflicts of interest in medical journals. The researchers targeted articles published by physicians and scientists that were reportedly involved in off-label marketing activities. The group found that one in seven authors fully disclosed their conflict of interest. Of the articles reviewed by researchers, only 15% contained adequate disclosure. Researchers are concerned because journal authors may have a strong influence on the prescribing habits of other physicians considering an off-label therapy.

Not defeated but most likely in some agony, KV Pharmaceutical filed for bankruptcy. The company’s CEO said the company has not realized the full value of its most important drug because the FDA has not enforced KV’s marketing exclusivity on the product. Since the exclusivity has not been enforced, several state Medicaid programs have made access to the drug more difficult.

Forest Labs has received another yellow card, in the form of an untitled warning letter, from the Office of Prescription Drug Promotion at the FDA, for statements made by two of its sales representatives. According to the letter, the representatives failed to communicate the drug’s appropriate patient population as well as its limitations of use. In addition, the reps allegedly minimized the risks associated with the product. The OPDP is especially concerned because the company is already under a CIA.

A law firm in Hong Kong has issued a report indicating that more Asian countries are joining in the anti-corruption game. While the FCPA and UK Bribery Act remain the top dogs in driving anti-corruption reform, individual countries are increasingly enacting their own anti-corruption laws. The group found that while the laws are similar in structure, enforcement varies from country to country.

And speaking of anti-corruption, there was certainly a whirlwind of enforcement activity last week. First on the podium is Fresenius Healthcare AG, the world’s largest provider of dialysis equipment and services. The company notified the SEC and DOJ it was conducting an internal investigation into possible violations of the FCPA. Next up, generic drug maker Teva says it has received a subpoena for documents related to its business practices in Latin America. Teva is cooperating with the feds and has hired independent counsel to conduct an investigation. Rounding out the anti-bribery “awards,” Pfizer  announced FCPA settlements with the government for over $60 million. The company’s subsidiary, Pfizer H.C.P. Corporation, agreed to pay $15 million to resolve an FCPA investigation and will enter into a Deferred Prosecution Agreement with the DOJ.  Pfizer H.C.P. admitted to paying $2 million in bribes to government officials in Russia, Bulgaria, Croatia and Kazakhstan. The DOJ says self-disclosure and cooperation led to a reduction in the base fine and the company is not required to hire a corporate monitor. Apart from the subsidiary settlement, Pfizer Inc. and Wyeth negotiated settlements totaling $45 million with the SEC, to resolve civil FCPA charges.

Well, that brings us to the end of this week’s Review.  We’ll be going through a bit of Olympics withdrawal this week without the nail-biting competition, or of course, those awesome interactive Olympic-themed Google Doodles! On the up side though, we can finally look forward to a good night’s sleep. That television coverage to midnight and beyond is a killer! Time to get back to normal, and that includes keeping an eye on the news for all of you. 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!

Week in Review, July 22, 2012

NXLevel Compliance Team

The PharmaCertify™ Team

Stormy weather! Have you had some? While lightning, high winds and hail are certainly no fun, there are parts of the country that really needed the rain that came with them. If you’re facing another rainy, stormy day, we are thinking of you and have just the ticket to pass the time…this week’s News in Review.

The storm clouds parted for the industry in Texas. The state’s Supreme Court ruled pharmaceutical manufacturers are not responsible for communicating a drug’s risks, even when the drug is marketed directly to patients. The decision overturned a previous appellate court ruling. The case at hand involved a patient who developed a Lupus-like syndrome after taking Remicade. The patient and her husband blame the drug, and say an informational video they watched at a physician’s office did not adequately communicate the risks associated with use of the drug. The Supreme Court ruled that the drug company provided adequate warning information to the patient’s physician, and since the patient had visited with her physician and decided to take the drug prior to viewing the video, there was no need for them to make an exception to the learned intermediary doctrine.

The tempest surrounding the Vermont data mining law may finally have subsided. Following the Supreme Court’s decision that effectively overturned the law, a U.S. District Court for Vermont has decided the state must pay IMS Data $2.4 million in legal fees. The company had asked for just over $4 million in fees, and the state asked that the amount be reduced to just under $1.5 million. The court settled on $2.4 million, bringing the total Vermont has had to pay to $4.1 million ($1.7 million went to PhRMA).

The time for has come for Travelers Insurance to put up that umbrella of theirs. Cephalon has brought suit against the insurer to stop them from attempting to recover $17.4 million the company claims it paid to cover off-label prescriptions for a cancer pain medication. Cephalon says federal law provides the FDA with the authority to deal with off-label promotion and does not give Travelers the right to file a suit.

Rounding out the litigation round-up, a new suit has been filed against Abbott related to off-label use of an anti-seizure medication. Plaintiffs claim the manufacturer failed to provide adequate warning on the product’s label regarding the risk of birth defects if women use the drug while pregnant.

China’s data privacy laws are leaving companies stranded in the rain during an FCPA investigation. A survey of FCPA compliance professionals reveals that the laws are impeding investigations into possible violations of the FCPA. Chinese data privacy law is very strict when the document in question could be categorized as a state secret. Experts say that since China so broadly defines a “state secret,” examining documents outside the country’s borders is difficult.

The pharma industry in India has decided to not fight the winds of change, and, in principle, has agreed to enforcement of the Department of Pharmacy’s marketing code. A representative of one of the country’s industry groups said a few companies have blemished the reputation of the entire industry. The Department of Pharmacy has agreed to make the code more practical and implementable. The code could be in place by the end of the year.

Well you’ve reached the end of this week’s Review! Is the rain still falling in your neck of the woods? Look on the bright side, all that rain gave you a good excuse for not doing any yard work during the weekend. Stay dry and have a great week everyone!

Week in Review, July 13, 2012

NXLevel Compliance Team

The PharmaCertify™ Team

Whew! The past few weeks certainly have been hot. Kinda makes you want a jump in a pool or run through a sprinkler doesn’t it? Or better yet, hit the beach! The cool ocean water, the sea breeze evaporating the sweat from your forehead, a cooler of ice cold…um…water (hey, this is a family blog) by your side. Devine, isn’t it? If you’re lucky enough to pack up the minivan and head to the coast this weekend, we salute you! Grab those beach chairs, beach towels and your sunscreen and get your cool on! For those of us not so lucky, we’ll have to sit in our air conditioned living rooms and pretend. But before any of us can escape to the real or metaphorical beach, we have Friday to tame. As you gather you’re reading material for the weekend, take a read of the week that was…the News Week in Review.

The change in the Massachusetts gift ban is not all sunshine and sand castles with med students in the state. In June, over 100 med students, residents, and physicians sent a petition to Massachusetts governor, Deval Patrick, asking him to keep the gift ban in place. Accompanying the petition was a letter from Harvard and Brown medical students expressing concern that the trust between doctor and patient is eroding because of the perception the profession was  “on the take” from the life sciences industry. On July 3, the governor responded, saying the change in the law was a small one and would afford companies a better opportunity to educate medical professionals about new medications and devices. He also said loosening the state’s regulations would better align with the PhRMA Code. The med students say the PhRMA Code should be a starting point, not the standard.

Might the wave of the first corporate charges under the UK Bribery Act be beginning to swell? Perhaps, and the lucky winner is…BP. The Serious Fraud Office has brought BP into a bribery investigation concerning one of the company’s contractors in Azerbaijan. No BP employees are suspected of having paid bribes, but under the Bribery Act, the company could be held liable for the actions of its contractor. So don’t forget those vendors and third parties when you’re planning your anti-bribery training.

Orthofix will be heading to the shore with $7.4 million less to spend on the boardwalk. The company and the DOJ reached a settlement to resolve bribery charges involving a former distributor in Mexico. After an internal investigation, the company notified the DOJ that a distributor may have paid bribes to Mexican health officials. Orthofix has entered into a Deferred Prosecution Agreement with the DOJ and Consent to Final Judgment with the SEC. The $7.4 million payout represents $5.2 million in profit disgorgement and $2.2 million in fines.

Continuing to surf that anti-corruption wave, we have a blog from Tom Fox about the GSK settlement. Wait, wait you say…that wasn’t an FCPA or Bribery Act settlement. No it wasn’t but, Mr. Fox highlights a couple of provisions in the GSK CIA that should be of interest to “FCPA compliance practitioners.” The first provision was GSK’s agreement to change the way it compensates its sales force by removing sales goals from certain territories. The other item of note was the agreement that any executives who engage in illegal activities would be required to return their bonuses and long term incentives.

For our friends in Texas, we realize the beach could be quite a haul. So for future reference, you might want to consider taking a dip in the water park this dentist is building at his home. Oh, and according to the state’s AG, he may be building it with your money, since the dentist in question is at the center of two large Medicaid fraud suits.

Well, I hope we’ve helped you decide which piece of summer reading you’ll be taking along on that visit to your own personal “beach.” Keep cool this weekend everyone…don’t forget the sunscreen!

Week In Review, July 6, 2012

NXLevel Compliance Team

The PharmaCertify™ Team

What a week – record heat and dangerous storms that led to widespread power outages. Seems Mother Nature brewed up some “fireworks” of her own this week. We hope everyone has kept cool during this record heat wave, especially those who found themselves without power. The weekend is almost here. So book some quality pool time, or relax inside in the a/c and get a rousing game of canasta going to escape what promises to be a hot weekend. But before you start working on your game night menu, take a gander at what was cooking in the news this past week. Time for the News Week in Review.

Obviously, the hot story of the week was GSK’s $3 billion settlement with the government. In case you missed it, the company pled guilty to two counts of misbranding and one count of failing to report safety data, and will pay $1 billion in fines and forfeiture on the criminal offenses. On the civil side, the company agreed to pay $2 billion to settle False Claims Act pricing fraud allegations. Most of the offenses occurred between 1998 and 2003, with some price reporting issues dating back to 1994. As a result of the settlement, GSK will also enter into a CIA with the OIG.

A number of states immediately publicized their share of the historic settlement. Here’s a smattering of who got what in the GSK lottery: Ohio, Indiana, Massachusetts, Rhode Island and New Jersey.

Apparently, one of the more salacious tidbits revealed in the complaint against GSK was that the company paid Dr. Drew Pinsky $275,000 to speak about Wellbutrin in a manner in which it would not appear he was speaking for GSK. According to the complaint, Dr. Drew’s payment was for two months work in 1999. Yes, you read that right, 1999. Based on the media response you’d think this happened last month. We’ll just chalk it up to a slow news week.

Moving on, an SEC official is advocating a compliance defense for the FCPA. Jon Jordan, a senior investigations counsel in the commission’s FCPA unit, published an article noting the existence of a compliance defense through the UK Bribery Act, and said the U.S. should consider similar defense for the FCPA. Such a defense would require that companies demonstrate they have sufficient procedures in place, Jordon says.

Over to India, where one has to ask, is the Department of Pharmaceuticals going to bring the heat down on the industry? The Department has scheduled a meeting with the industry to discuss making the drug marketing code mandatory. The voluntary code seeks to put an end to the provision of gifts and incentives to physicians. The meeting is in response to a letter from a member of Parliament stating she had received evidence the code was not being followed. Members of the Medical Council of India, the group that regulates doctors, are also scheduled to attend.

It may be winter in Australia, but seems folks are pretty hot over the recently updated Medicines Australia Code of Conduct. The Code was submitted this week to the Australian Competition and Consumer Commission for approval, but even before the details were known, critics said it did not go far enough in bringing transparency to the financial relationship between physicians and the industry. The details are out, and companies will have to disclose aggregate payments to all physicians for speaking, consulting, serving on advisory boards, and educational sponsorships. The Code, which goes into effect in January, also bans the provision of branded items, such as mugs and pins, and personal gifts to physicians.

Feeling the financial heat, KV is suing the FDA for the agency’s failure to stop pharmacies from compounding a version of the company’s pre-term labor drug. KV claims the FDA is putting the financial interest of insurers over patients by allowing the compounding practice to continue. The active ingredient used by pharmacists to compound the cheaper drug is widely available, but has not been cleared by the FDA. KV says if the FDA fails to act, the company will be bankrupt in three to six months.

That brings us to the end of this week’s News Week in Review. We hope you all enjoyed your mid-week holiday. Next year, as you celebrate the heroic actions of George Washington, Thomas Jefferson, Benjamin Franklin et al, a South Carolina lawyer claims we should honor whistleblowers as well. Really? Talk about a stretch to promote your business.

Keep cool everyone, and have a great weekend!

Week in Review, June 22, 2012

NXLevel Compliance Team

The PharmaCertify™ Team

The smell of peanuts and Cracker Jack, and the ping of the bat are hanging in the air of Omaha, Nebraska. The College World Series was in full swing this week, and will reach its conclusion, perhaps, over the weekend. Today’s game, featuring the Arkansas Razorbacks and South Carolina Gamecocks (repeat anyone?), will determine who faces Arizona in the finals. As much as we love America’s pastime around here, the games can get a little long. So to keep it interesting, we offer a little reading material – this week’s News Week in Review.

Both of the teams in tonight’s game are members of the SEC. Another SEC (the Securities and Exchange Commission) was making news this week when it gained approval to notify former Siemens executives they were on the hot seat with the US government. The SEC is pursuing civil charges against the executives for violations of the FCPA. The Commission received permission from a federal court to notify the defendants via notices in German newspapers and e-mails to their lawyers. The former executives will have 20 days to respond.

Medicines Australia is voting on a new Code of Conduct. On deck for consideration is the reporting of physician spend information. The measure, which would include the reporting of payments for speaking and hospitality, is supported by many of the industry’s largest companies. Some in the industry fear the measure will discourage doctors from agreeing to speak. As for physicians, the Australian Medical Association says it will not stand in the way of the new Code.

Seroquel (Quetiapine) has been put on waivers by the Department of Defense. Now doctors in CENTCOM will have to sign a waiver to prescribe the drug for troops. The drug is being prescribed, off-label, to deal with insomnia and Post Traumatic Stress Disorder (as are other atypical anti-psychotics). As the use of anti-psychotics rose, evidence began to mount that the drugs could cause irregular heartbeat and even death. Seroquel’s label does warn of cardiac issues. Concern over the cardiac affects and widespread use of the drugs prompted the DOD to take measures to more closely monitor their use, and in the case of Seroquel, restrict the use altogether.

The UK Bribery Act may have been thought of as a home run in the fight against corruption when it was passed over a year ago, but with little legal action occurring since the law went into effect, some have been left feeling a little underwhelmed. Here’s the good news though, the law did prompt action among multinational corporations to get their anti-corruption compliance ducks in a row. That’s good news because according to the OECD’s Working Group on Bribery, the Serious Fraud Office is working on 11 cases and has 18 other cases under consideration. Have you fired up your anti-corruption training yet? If not, we can help.

Directly from the world of baseball (sort of) comes news that a baseball hall of famer, along with a senior Abbott executive, is being investigated by the SEC for insider trading. The investigation stems from the purchase of Advance Medical Optics by Abbott. The SEC believes the former player, along with a teammate and others, profited from advanced knowledge of the sale. The Abbott executive is believed to be partly responsible for leaking the information prior to the purchase.

Worried that the FDA may take you out at the plate if you do the social media slide? Well, your man on the ground, Pharmaguy, reports that the FDA is too busy with all the low hanging fruit in violative product promotion to worry about social media. While attending a conference on social media, Pharmaguy started a discussion regarding meta tags and how the organic search results were essentially branded ads without the required safety information. A supposed expert in the audience said the FDA was too busy dealing with all the low hanging fruit to be worried about such things. Pharmaguy’s belief that the FDA is interested it the issue now is based on a Notice of Violation letter issued to Novartis about its use of meta data and a Facebook share widget.

Well that’s about it everyone. We’re headed out to get the bratwurst started on the grill, and prepare for tonight’s game. Before we go, one more obscure story you may not have heard about. The U.S. Supreme Court decided that drug sales reps do not have to be paid overtime. And someone out there says the decision should not prompt crying among sales reps.  (There’s no crying in pharmaceutical sales, people.)

Have a great weekend everybody, and Fear the Fish!