anti-bribery

Week in Review, October 21, 2013

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

A U.S Senator calls for an investigation into the relationship between pharmaceutical companies and the FDA, the definition of “foreign official” under the FCPA is debated in Florida, the Baycol False Claims Act case moves forward and 25 manufacturers settle with Vermont over charges of failing to file required reports.

The World Series gets underway this Wednesday with the Cardinals returning after a one year hiatus to face a scraggly, scrappy Red Sox squad. With the team from Boston representing the American League, no doubt the boys from St. Louis have gained a new legion of fans in New York. So, do you have a side in the battle, or will you just be glad when it’s over, and you can get back to The New Girl and Sleepy Hollow? Whether you’re looking forward to the first pitch or the last, we’re here to help fill the time with the current version of the News in Review.

U.S. Senator, Joe Manchin, has put a call into a different type of commissioner to investigate an alleged pay-for-play scheme between the FDA and pharmaceutical companies. In the letter to FDA commissioner Margaret Hamburg, Senator Manchin expresses concern about reports of pharmaceutical companies paying thousands of dollars to attend FDA advisory meetings about the safety of pain medication. He would like to see a full senate investigation into the allegations to shed light on whether the relationship between pharma companies and the FDA caused any delay in the rescheduling of addictive pain killers.

A meeting on the mound is needed to settle an FCPA case in Florida. The case is now in the hands of three judges, and at the crux of the discussion is everyone’s favorite topic – the definition of a foreign official. More specifically, the case focuses on the definition of an “instrumentality.” Two telecom executives are accused of bribing the government-owned Haiti Teleco and defense lawyers have argued that an instrumentality has to be a direct part of the government under the FCPA, which is not the case with Haiti Teleco.

Internal controls charges are on the rise in FCPA cases, leading the Cadwalader law firm to wonder if the DOJ and SEC are poised to begin charging independent directors for failing to assure or maintain proper controls. Several companies have faced such charges recently, and as was demonstrated in the Orthofix case, companies can be charged with a violation for not having financial controls or an adequate compliance program in place. The FCPA guidance states that compliance begins with board members and senior executives, so the idea of independent directors being charged for the lack of proper controls isn’t far-fetched.

Upon further review, a whistleblower case against Bayer will move forward, but only on the grounds that the Department of Defense was defrauded, not federal healthcare programs. The False Claims Act case, which alleges that Bayer was deceptive in its marketing of Baycol, was dismissed last year because the court said the whistleblower failed to meet the specificity threshold related to false claims. The appeals court reversed the lower court’s decision.

Boston Scientific and its Guidant division have agreed to pay $30 million to settle charges of knowingly selling defective heart devices to facilities that treat Medicare patients. The government alleged that despite being aware of the problem, Guidant continued to sell defective stock and sent misleading communications to doctors in attempt to hide the true nature of the defect. The government also alleged that Guidant attempted to hide the defect from the FDA.

Vermont racked up 25 strikes against manufacturers under its Prescribed Products Gift Ban and Reporting law. The state’s Attorney General recently announced settlements with 25 manufacturers for alleged violations of the law. Most of the companies involved were small manufacturers and most of the charges levied were for failure to file the required reports. One manufacturer faced six charges of violating the gift ban.

We close with a reminder that the PharmaCertify team will be on-site at the Fourteenth Annual Pharmaceutical Regulatory and Compliance Congress next week. So if you’re attending, don’t forget to stop by the booth, say hi, and ask about our suite of compliance training modules and apps.

Have a great week everyone.

News Week in Review, October 14, 2013

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

An industry watchdog group raises concerns about pay-for-play, the Supreme Court considers medical devices, one company claims its trade secrets were sent overseas and a critique of off-label promotion is, well, criticized.

“In fourteen-hundred and ninety-two, Columbus sailed the ocean blue”…certainly one of the more effective pneumonic devices from our younger days. So it is that today we celebrate the journey that would lead Mr. Columbus to “discover” the Americas. Unless of course you’re Canadian, in which case…Happy Thanksgiving! There is much to celebrate in North America today, but before you dig into the turkey and stuffing or take advantage of the Columbus Day sales at the local mattress emporium (nothing says “woo hoo, America was discovered!” like a new mattress), we set sail with this week’s News Week in Review.

The discovery of emails about meetings between government regulators and industry executives has raised concerns about the relationship between the two groups. The emails reveal that since 2002, pharmaceutical companies paid their way into the IMMPACT (an organization dedicated to improving clinical trials for new pain treatments) meeting, where they were able to discuss clinical trial procedures with regulators. The industry watchdog group, Public Citizen, says this raises concerns of a pay-for-play arrangement, in which drug companies could buy access to regulators, other health officials and academics. One of the founders of IMMPACT acknowledged that the email messages could appear problematic on the surface, but no one has complained about pharmaceutical companies paying for representatives to attend the meetings.

The U.S. Supreme Court could be exploring a case of a patient’s ability to sue a device maker under state laws when a problem with an FDA-approved device occurs. The case involves an Arizona man who has sued Medtronic over a pain medication pump which he claims left him paralyzed. At the time the man was using the pump, the device was approved by the FDA. The device was eventually removed from the market following a warning from the FDA about Medtronic’s failure to disclose all the risks. The Court has turned to the Obama Administration for an opinion on the matter.

A semi-retired Harvard doctor is suggesting that the Massachusetts legislature define a modest meal as one comparable to what one would receive at a hospital cafeteria. The doctor testified before the Committee of Public Health about a bill that would set a standard for a modest meal. He lamented the repeal of the existing meal ban and lectured about the so-called evils of pharmaceutical marketing.

Three former Lilly employees may be forced to walk the plank after they were indicted for handing over company trade secrets to a Chinese pharmaceutical company. According to the indictment, two of the employees emailed information about nine early-stage research projects to a third employee, who was also employed by the Chinese drug company. Lilly claims the company has a value of $55 million.

Fresenius, the maker of Propofol, ceased shipments of an anesthetic drug to Morrison-Dickson for several months, after the wholesaler accidently sent 20 vials of the drug to a Missouri prison for use in lethal injections. Fresenius will sell the drug to U.S. wholesalers only under the condition that they not sell it to prisons or jails. When company officials originally tried to reclaim the drug from the prison, they were told that decision would have to come from the state’s director of corrections or the governor. The state has agreed to return the vials.

In a case of the old world borrowing an idea from the new world, the U.K.’s Home Office is considering U.S. style whistleblowers awards in fraud, corruption and bribery cases. Currently, the U.K offers limited legal protections for employees who blow the whistle and the move is seen as one way to incentivize them. Some are concerned that the financial rewards will lead to bogus claims and raise questions about the credibility of a whistleblower as a witness.

A rehabilitation physician is trying to take the wind out of the sails of critics of prescribing drugs off label. Ford Vox, a physician at the Shepherd Center, responded to a recent article in the Washington Post about the number of off-label prescriptions written for patients covered by Medicare and Medicaid. Vox poked holes in the article’s assertions that off-label prescribing is inherently suspect, and that CMS has a responsibility to police physicians engaged in the practice. He notes that while focusing on one specific physician and drug, the article does not mention that the particular use is backed by research from 2006.

And so we end our exploration of all things compliance for this week. Fall has definitely arrived and as you map your compliance training curriculum for 2014, keep in mind that PharmaCertify™ offers the custom and off-the-shelf training solutions you need to help your crew navigate today’s murky compliance waters.

Have a great week everyone!

Week in Review, October 7, 2013

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

PhRMA’s assistant general counsel tells physicians the industry is spending millions to avoid reporting mistakes, Canada takes steps to limit access to physicians, and two different whistleblower cases are dismissed.

The PharmaCertify™ Team
In case you missed it, last Thursday was National Techie’s Day. So, if you find yourself lining up extra early outside the Apple store on the day of a new product release, or you can’t help but play armchair engineer while watching The Big Bang Theory, or you have a room in your house with enough computer equipment to launch a space shuttle…you probably had a good week. Rather then regale you with the celebratory details of our parking lot robot battles, we’ll stick with this week’s News in Review.

Garbage in, garbage out, or GIGO, in techie nomenclature, is what PhRMA says its members are working hard to avoid in their forthcoming Sunshine reports. Speaking to a gathering of family physicians, PhRMA’s assistant general counsel, Kendra Martello, said member companies are spending millions to ensure the accuracy of reports as much as possible. She emphasized that disputes between physicians and manufacturers are not good for anyone, but admitted that the industry is unsure of what to expect in the way of physician disputes when the first reports roll out.

A Canadian medical school is rebooting its policy regarding doctors’ contact with industry representatives. The North Ontario School of Medicine is creating a policy that would limit doctors’ contact with representatives. The dean of the school, Roger Strasser, acknowledged the importance of physicians having access to medical information, but only if that information is unbiased and well-researched. He said the policy would be more of a guideline than a rule.

Sanofi’s CEO, Chris Viehbacher, believes the industry needs to interface more with the Chinese government in order to deal with corruption in China. While speaking about doing business in emerging markets, Viehbacher said the industry needs to support the Chinese government’s efforts to deal with the corruption. He went on to say that all the companies under investigation have been cooperating with the government.

A federal judge has resorted to a forced quit shutdown of a misbranding suit against Amgen. The whistleblower in the case, who is a physician, and a co-complainant rejected the $1.8 million settlement they were to share as a result of a federal settlement with the company last year. The judge said that since original settlement was rejected, the government had the right to determine that nothing further could be litigated, so the whistleblower’s case was tossed.

The techies at Google have done an about face and are now offering Business Associates Agreements (BAA) for users of three of its apps, Gmail, Drive and Calendar. The BAAs do not cover any Protected Health Information transferred from one of the three apps to another Google app.

A whistleblower suit against the medical technology company, Masimo, has been dismissed. Three former sales reps brought the suit, saying the company had promoted two of its patient monitoring devices for off-label uses and improperly billed the government. The sales reps also claimed the company withheld sales data and interfered with subpoenas for sales records issued to federal insurance companies. The judge dismissed the case, saying the plaintiffs failed to provide any evidence that the company knowingly promoted the products for off-label use.

And with that, we reach the end of another News Week in Review. We close out this celebration of all things technical by asking if you are making the most of technology to deploy your compliance training solutions. The PharmaCertify™ eLearning modules and iPad apps are designed to deliver critical compliance content where your team needs it most – in the field and at their fingertips.

Have a great week everyone!

Week in Review, October 1, 2013

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

The False Claims Act goes global, the FDA chimes in on mobile apps, and we hear from the OPDP on social media guidance…sort of.

Have you seen them yet? They’re small in number now, but if you look carefully, you’ll see them. October has only just begun, and yet, they’ve emerged…Christmas decorations. For now, it may just be a small display of collector ornaments off in a corner, or an inflatable lawn ornament, or two, slyly mixed in with the Halloween bunch. And we haven’t even started raking the leaves yet! We’re nowhere near ready to even think about the mad rush of the holiday season, but we are ready to bring you the compliance news you need to know, with this week’s News in Review.

Not rushing the holiday season might be good for the nerves, but putting off the implementation of a good due diligence program is never a good idea. The actions of intermediaries continue to be a key risk area for companies doing business overseas. FCPA investigations are on the rise and the Serious Fraud Office has levied its first charges for violations of the UK Bribery. Prosecutors are not likely to take a kind view of companies that have a “check the box” mentality when it comes to assuring their intermediaries are operating in a compliant manner. Pre-contract vetting of agents and suppliers, on-going monitoring, and compliance clauses in third-party contracts, are critical steps in demonstrating you company takes the risks posed by the use of intermediaries seriously.

Federal regulators certainly seem to be in a hurry to utilize the False Claim Act globally. With a large percentage of finished pharmaceutical products and the vast majority of active ingredients coming from outside the U.S., the FCA was bound to be applied to misdeeds occurring in other countries. The recent Ranbaxy case, involving the company’s manufacturing facilities in India, is one example. The FDA has regulatory authority over manufacturing facilities making products for the U.S. market, and the Ranbaxy case demonstrates prosecutors’ willingness to apply the FCA to actions occurring outside our borders.

Bayer found itself in the news after the company allegedly breached the APBI’s Code of Practice when a high-ranking employee provided late night drinks to healthcare professionals attending a medical congress. An anonymous healthcare professional provided the information, and said a good deal of alcohol had apparently been consumed by those present. Bayer did not dispute that the employee bought drinks for the physicians, but the company took exception with the characterization that a good deal of alcohol had been consumed, and said that only £28.15 was spent.

The Australian Medical Association (AMA) wants to slow down the physician spend reporting requirements that the pharmaceutical industry is proposing. The group supports increased transparency, but feels reporting “tea and biscuit” payments would be administratively cumbersome and weaken the transparency system. The Association sent a letter to the group working on the requirements, asking for certain limits on transparency. The limits requested include a $500 starting point for payments to be reported; a two year window for the reports to be available; and a requirement for patients to supply an e-mail address when they want to access the registry of spend data.

The FDA delivered an early gift for medical mobile app developers. The agency announced it will regulate medical mobile apps that turn smartphones into a medical device or ones that allow an attachment, like a blood pressure cuff, to be plugged into a smartphone.

It’s been a long time coming, but at the Food and Drug Law Institute’s recent Advertising and Promotion Conference, OPDP chief, Tom Abrams, said he expects the OPDP to meet the July deadline set by Congress for the release of guidance on the use of social media. So, until the guidance is released, how does the industry handle product promotion in the social media world? One panel of experts at the conference suggested a review of OPDP Warning and Untitled Letters involving web based advertising could provide some clues as to FDA’s current thinking. Panel members noted that the FDA was focusing on claims in testimonials and case studies, as well as fair balance and accuracy.

And so ends the News in Review for this week. If your end of year plans (we know, we’re rushing things) include the distribution of mobile devices to field and home office staff, the PharmaCertify™ suite of commercial compliance modules are accessible on PCs or iPads and offer the up-to-date content your learners need where they need it most – in the field and at their fingetips.

Have a great week everyone.

News Week in Review, September 23, 2013

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

The PharmaCertify™ Team

The sun, the moon, and the stars have all given their approval for the change of season, so we can make the official call…it’s FALL! Cool, crisp days and changing leaves can’t be far behind. And if that isn’t enough to make you happy, the advent of fall means that “delightful” chore of cutting the lawn will be ending soon. Gee, what a shame. Whether your favorite fall activities include pumpkin carving, apple picking, or getting lost in corn mazes, there will be plenty of time for all of that later. Now it’s time to take a look at the news from the last week of summer, with this week’s News Week in Review.

The Massachusetts legislature is kicking off fall with a number of bills aimed at the relationship between physicians and industry companies. A joint senate and house committee will discuss the bills on October 1st. The bills under consideration include a ban on drug advertising; a ban, with a few exceptions, on gifts to healthcare professionals and their family members, which will also require annual reporting on the value of permitted gifts (um…isn’t there a law in place for this?); and one that will define what constitutes a modest meal at an educational/informational presentation. The last bill prohibits the provision of alcoholic beverages at the presentations, and prohibits educational or informational meetings from being held at “resorts, sporting clubs, casinos or other vacation destinations.”

While you’re watching those fall television premieres, watch out for those drug advertisements…they’re deceptive! Or so says a new study in the Journal of General Internal Medicine. According to the study, 8 of 10 ads for OTC drugs and 6 of 10 ads for prescription drugs contained exaggerated or misleading formation, left out vital information, or made meaningless lifestyle associations. The ads aired from 2008 to 2010 during the evening news timeslot (30 minutes) on the three major networks and CNN.

Two industry trade groups are looking for companies to turn over a new leaf when doing business in China. PhRMA and RDPAC (a trade group for foreign companies in China) prepared a joint memo to address industry corruption issues in China. The memo calls on companies to employ the highest ethical standards while conducting business in China, and to react swiftly if something occurs outside the parameters of a company’s code of conduct. The memo also calls on trade organizations to enhance their efforts to ensure physicians are better paid by the Chinese healthcare system, and to encourage the introduction of ethical standards for the entire healthcare sector.

The corruption scandals and investigations in China have put a chill on the relationship between physicians and the industry. Pharmaceutical sales representatives are making fewer visits to hospitals simply because physicians are refusing to see them, and because companies have been cutting back or eliminating the visits out of caution. Sales are also down in the country as a result of scandals and the lower sales have lead companies to cut back on their marketing and promotional activities. The CEO of Sanofi says there is “a lot of confusion out there” and he expects there to still be “turbulence” in the marketplace over the next few months.

Prosecutors in the U.K. have harvested new laws and guidelines to help them pursue Bribery Act cases. A law that will allow the use of Deferred Prosecution Agreements to settle Bribery Act cases should become effective in February. The use of DPAs is expected to reduce the number of lengthy investigations, and provide companies a way to avoid the stricter penalties. The U.K. Sentencing Council has also released draft sentencing guidelines for violations of the Bribery Act. The guidelines include a tiered rating for determining a violator’s level of guilt under the law (e.g., a violator was an instigator vs. being coerced or intimated in to violating the law). The guidelines also state that fines against a company must be significant enough to have a real financial impact.

Google’s leaf pile just keeps getting bigger! The company announced it’s going to step into the bio-pharmaceutical industry, and form a research company dedicated to “health and well-being, in particular the challenge of aging and associated diseases.” The company will be called Calico, and the CEO will be Arthur Levinson from Genentech.

Now that fall is here and the daylight hours are waning, this is a good time to shift back to Sunshine. With Sunshine Act data collection in full swing, PharmaCertify’s, The Sunshine Act: The Federal Physician Spend Disclosure Law, will help you ensure customer-facing colleagues are well-versed on what information needs to be collected and reported.

Have a great week everyone!

Week in Review, September 16, 2013

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

The PharmaCertify Team

If you are reading this, we’ll assume you survived another Friday the 13th. How did you spend the day? Did you stay at home and not take any chances or was it business as usual? We of course stayed abreast of the compliance news of the week, albeit while keeping our lucky rabbit’s foot at the ready and digging out the usual four leaf clover. After all, Friday “December” 13th will be here in a flash. So, now that you’ve thrown a dash of salt over your shoulder and safely navigated the cracked sidewalks of your daily commute, we invite you to check out the News Week in Review.

Accepting drug samples could prove to be bad luck for Australian physicians if new ethical guidelines are accepted. The Royal Australasian College of Physicians is proposing a ban on drug samples in its draft guidelines on interactions with the industry. The RACP says samples are largely a “marketing exercise,” and access to samples is in the best interest of patients.

Not long ago, representatives from the European Union Chamber of Commerce were talking about how no Chinese pharma companies were being investigated for bribery. Well those words must have had brought some bad voodoo with them. No sooner was the ink dry on that announcement then news came that Chinese insulin maker, Gan & Lee, and a division of Sino Biopharmaceutical, were both accused of paying bribes to doctors to increase sales. In the case of Gan & Lee, a whistleblower says the company gave away overseas trips to doctors in order to boost sales in advance of an initial public offering. The revelations about Sino were made via a report on China’s state run television network. Sino was also accused of providing vacations to physicians in order to increase its sales.

Executives at Quest Diagnostics and LabCorp should have avoided ladders and black cats since they now find themselves the subjects of a false claims whistleblower suit in Virginia. The case, which was unsealed in August, alleges the two companies overcharged Virginia’s Medicaid system for diagnostic tests. In one instance, Quest is accused of charging Medicaid $10.42 for a test it charged others as little as $1.42. The complaint, which was filed by Hunter Laboratories and its CEO, Chris Reidel, is asking for $11,000 in civil penalties for each false claim.

PhRMA and the Maine Pharmacy Association are two of the groups looking for all the luck they can get as the group challenges Maine’s drug importation law in court. The new law allows consumers to purchase drugs from mail order pharmacies in Canada, Australia, New Zealand and the UK. The lawsuit claims drugs from the other countries are not subject to the same safety controls as those produced in the U.S. and the FDA has already warned states about their residents purchasing drugs from other countries.

The International Society of Medical Publication Professionals (ISMPP) has created a task force to help clarify the impact of Sunshine on medical publications. While publishers have no direct reporting responsibility, the activities publishers perform in conjunction with researchers could fall under the definition of indirect payments. The task force identified a variety of activities that should be tracked, including statistical support provided specifically for the publication. In addition, applicable manufacturers should track all transfers of value associated with publication costs and keep the data available for reporting and the dispute process.

CME providers have been making good use of their good luck charms recently. According to a report from the ACCME, the number of providers receiving accreditation with commendation has risen from just 3% in the November 2008 cohort to 28% in the July 2013 cohort. The total number of accredited CME providers of CME is down, suggesting that the tough ACCME standards may be thinning the herd.

With that, we’ve reached the end of another Review. While you may have been lucky enough to navigate another Friday the 13th, leaving your compliance training to chance in this age of increased regulatory focus is not such a good idea. More than ever, your sales and marketing teams need to integrate solid compliance practices into their daily activities. That’s why our Good Promotional Practices module includes topics like Gifts, Meals and Entertainment, Meetings and HCP Consultants and On-Label Promotion. Contact Sean Murphy at smurphy@nxlevelsolutions.com to see a content outline.

Best wishes for a great week everyone!

News Week in Review, September 9, 2013

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

The PharmaCertify Team

That plaintive wail you heard in the distance last week may have actually been the low groan of children across the country as they boarded buses, or trudged their way back to school last week. With the passing of Labor Day, summer came to an unofficial end, and schools welcomed al (those eager and those less enthusiastic) back to reality. And for those of us who have aged beyond the school years, a heavier rush hour commute was our welcome back to reality. Good times all around. Enough waxing poetic, it’s time to swing open our own school doors and ring the first bell on this week’s News Week in Review.

A new survey shows that physicians need more education about the Sunshine Actor. The survey shows a ten percent increase in physicians who say they are “somewhat aware” to “very aware” of the law’s requirements. However, almost half of the respondents stated that they are unaware of the law. The survey also delves into the impact of the law on industry-physician relationships. Almost 40 percent of the physicians say they believe the law will negatively impact their relationships with the industry, and 21% said they would end their relationship with a company if inaccurate payment information is made public.

A federal Circuit Court has offered a whistleblower an eighth opportunity take what some would consider to be a generous makeup test. The court asked for yet another amended complaint from the whistleblower, who had filed a False Claims Act case against Bayer. The whistleblower alleges Bayer hid the dangers of two if its drugs and provided kickbacks when promoting those drugs. She claims that when she objected to the marketing tactics, she was fired. The seventh complaint alleged violations of the false claims acts of twenty one states, Washington D.C. and New York City. The Circuit Court judge tossed the state claims, along with her emotional distress and misbranding claims, but gave her thirty days to file an amended complaint.

Major Pharmaceuticals found itself in detention as a result of its settlement with Texas. The company agreed to pay $5 million to settle claims it misreported prices of generic drugs, which resulted in the state overpaying for the drugs. The case was initially brought by whistleblower, Ven-A-Care Pharmacy, and the state recently decided to join the case.

In China, foreign pharma companies haven’t exactly been the teacher’s pet lately. But, the chair of the European Union Chamber of Commerce in China’s pharmaceutical work group, Bruno Gensburger, said China is unfairly targeting foreign pharmaceutical firms in its bribery and price fixing investigations. Gensburger said the targeted firms have global SOPs in place and have generally been operating in a responsible manner. He went on to say that no Chinese company has been targeted for investigation.

In its recent analysis of the global reach of the Sunshine Act, the law firm of Fulbright & Jaworksi LLP explained that Sunshine has applicability to foreign firms that have a business presence in the U.S. CMS has established an applicable manufacturer as one having a physical location in the U.S. or conducting business in the U.S., either directly or through a legal representative. Manufacturers need to consider payments made to U.S. physicians who practice abroad, but are actively licensed in the U.S.

Well, the dismissal bell is ringing on this edition of the News Week in Review. The start of a new school year reminds us that 2014 isn’t far away and this is a great opportunity to review your compliance curriculum and see where a fresh take might be needed or a new topic could be added. From Commercial Compliance Overview, to Good Promotional Practices to the Sunshine Act, PharmaCertify offers the up-to-date training your learners need to help integrate critical compliance awareness into their daily activities.

Have a great week everyone!

News Week in Review, August 26, 2013

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

The PharmaCertify Team

Summer is winding down, and while we look forward to a holiday weekend, it’s time to get ready for the return of college football! It’s that wonderful time of the year – when we meticulously organize the tailgate party shopping list and dust off the car flags. And as we ponder the critical question of “pork or beef for the weekend barbeque?” we start you with a full menu of the compliance news you need to know, in this week’s News in Review.

We start this tailgate party off with a new state twist on Sunshine. The Oregon Department of Justice accused two heart doctors of breaking the state’s Unlawful Trade Practices law for not revealing to patients they received payments from device maker, Biotronik. The doctors were paid between $400 and $1250 for allowing Biotronik sales representatives in the operating room while the company’s defibrillators were being inserted. The Oregon DOJ said the doctors misrepresented their services as being for the “exclusive benefit of patients” when they didn’t inform patients that the sales representatives would be present during their procedures. A $25,000 settlement was reached and the two doctors agreed to tell patients about any potential conflicts of interests in the future.

Canada scored on its first foreign bribery trial. As a paid agent for a Canadian technology company, the defendant violated a section of Canada’s Corruption of Foreign Public Officials Act (CFPOA) when he provided bribes to Air India officials and the India Ministry of Civil Aviations to secure a contract to supply facial recognition software. The case demonstrates the wide berth in the definition of a foreign official under the CFPOA. The court held that the intent of paying a bribe was enough to constitute a CFPOA offence. Sentencing is pending.

The consultant detained in China in the wake of pharmaceutical industry bribery scandals has now been sidelined. According to the British Embassy the consultant, a British national, was arrested by the Chinese government on August 19th. The embassy declined to comment on the specific charges related to the arrest. A spokesperson for the consultant’s family said that his wife and his business partner were also arrested.

A penalty flag has been thrown on another pharmaceutical company for illegal activities in China. A whistleblower told a Chinese newspaper that Eli Lilly paid Chinese doctors $4.9 million in bribes and unlawful payments between 2011 and 2012. Lilly said it had not been able to verify the allegations, but company officials would continue their own investigation into the matter.

Medical meeting planners huddled to discuss the challenges facing their industry. The roundtable meeting of senior level meeting planners cited compliance requirements as one of their biggest challenges. One of the attendees said the issue extended beyond compliance with ACCME standards to industry requirements (e.g. PhRMA Code) and country and state laws. Planners also referenced the increasingly stringent approval requirements necessary to obtain CME credit.

At least one physician can see both sides of the ball when evaluating the Sunshine Act. Cardiologist John Mandrola points out that while patients should know what transfers of value their physicians receive from industry, there are drawbacks to the Act. Mandrola is concerned that the transparency brought by Sunshine will harm innovation by causing most physicians to pull back on their interactions with the industry.

We’re almost a full month past the start of data collection and the Sunshine Act continues to be a hot topic. PharmaCertify’s customizable eLearning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, covers the topics needed to keep you team up-to-date on the scope of data that needs to be collected and what will eventually be made public. Contact Sean Murphy at smurphy@nxlevelsolutions.com to learn more or see a content outline.

With that, we blow the final whistle on this edition of the News Week in Review. Have a great week everyone and Go Team!

Week in Review, August 12, 2013

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

The PharmaCertify Team

Break out those LPs and dust off your turntable, Monday was Vinyl Record Day! Count us among those who still miss that crackling and popping quietly emanating from our favorite disco, rock or R&B album. And we can’t forget all of that amazing cover art – Kansas, Left Overture, Yes, Relayer, or of course the Beatles, Sargeant Pepper’s Lonely Hearts Club Band, just to name a few. Before we lose ourselves (and you) too deeply in the musical formats and artwork of yesteryear, we first turn our attention to the rhythm and blues of this week’s News in Review.

Allegations of bribery by pharmaceutical companies in China continue to spin. Documents provided to a Chinese media outlet accuse Sanofi of paying $280,000 in bribes to over 500 doctors. In the documents, a whistleblower claims doctors were paid 80 yaun every time a patient bought one of the company’s drugs. Sanofi officials claim they are taking the allegations very seriously, but made no comment as to whether they were conducting their own investigation.

The DOJ is marching firmly to the False Claims drum beat, as the agency has filed a brief asking a federal appeals court to overturn a decision by a US district court against Takeda. The whistleblower suit claimed the company hid adverse events associated with a pair of drugs, causing those drugs to be prescribed more often than if the adverse events had been known, and subsequently causing false claims to be submitted. A U.S. district court judge dismissed the case, saying the whistleblower had failed to provide evidence of the false claims, and the adverse events were not material to the decision by the federal government to pay for the drugs.  The ruling went on to assert that False Claims Act liability could not be premised on failure to report adverse events to the FDA. The DOJ believes that adopting such reasoning could affect the government’s ability to enforce the False Claims Act.

The CME Coalition has a new release to help CME program providers and others navigate the Sunshine Act. The group’s Sunshine Act Compliance Guide provides recommendations on issues like meals for attendees and speakers and unaccredited CME. The guide also features a “compliance decision tree” to help CME program organizers make quick decisions on physician payments.

CMS had a hit of its own with the release of more FAQs on the Open Payments site. The list now includes information on how newsletters that include disease state information should be handled; an answer on whether textbooks donated for general use are reportable; and clarification on the 90 day exclusion for the loan of a medical device.

It’s been more of the same old sad song for reps trying to access oncology practices over the last year. For the second year in a row, oncologists were the most restrictive specialty, with 65% enforcing moderate to severe access restrictions. New products seemed to be the key, as reps carrying a new product saw doctors 10 times per year on average, compared to 7 times per year for those detailing older drugs.

Well, that’s about it for this week’s Review. If you’re looking to round out your compliance training playlist, PharmaCertify’s Good Promotional Practices module covers the “classics,” like gifts, meals and entertainment, while mixing in new topics like promotion through social media.

Have a great week everyone and we’ll see you right back here on this same frequency next week!

Week in Review, July 29, 2013

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

The PharmaCertify™ Team

Christmas in July. It’s gone from a fun little saying to a marketing gimmick to help clear out the last of the summer merchandise with Christmas shopping-esque sales. Oh, and let’s not forget the cable networks breaking out all your favorite holiday movies and specials in an effort to gain summer viewers. (BTW…still waiting on someone to show the Star Wars Christmas special. Where’s the love??!!) So, who are we at the News Week in Review to buck this trend? Pull out your jingle bells and put on your Santa hat, it’s time for Christmas in July in this week’s News Week in Review.

Facilitation payments – naughty or nice? Well in certain countries they are definitely naughty, and while “nice” may not be the exact term one wants to use when talking about them, facilitation payments are certainly a reality of doing business in some countries. A columnist with Compliance Week points out that no compliance officer wants to see bribes labeled as facilitation payments, but if paid as intended – to speed up an action a government official would do anyway – then there shouldn’t be an issue. Governments are increasingly including bans on facilitation payments in their anti-corruption laws, but are such bans realistic considering the reality of the global business environment? The U.K. Bribery Act was the first to ban facilitation payments, but now there is a movement within the government to repeal that section of the law. Canada’s recent amendment to its anti-corruption law will phase out facilitation payments, but the no time table was indicated for the phase out.

The Chinese government has been busy handing out lumps of coal as it expands its probe into the pharma industry. Thirty-nine hospital workers will be punished for taking bribes, two more Chinese employees with Astra-Zeneca were questioned in connection with an investigation of that company, and an American from an unnamed company was detained by the government in connection with an industry investigation. A spokesperson for the U.S. Embassy said they were aware of the situation and were providing appropriate assistance.

The industry can expect some unwrapping of the details relative to drug patent settlements from the Federal Trade Commission going forward. Speaking to lawmakers, FTC Commissioner Edith Ramirez said the agency plans to continue on with current pay-for-delay cases it is litigating and will be investigating new settlements to determine if they are legal. She acknowledged that most patent settlements do not involve a pay-for-delay component but the FTC’s goal will continue to be to stop the anti-competitive settlements that do.

In Chile, where it actually feels like Christmas, the Chilean Medical Association (CMC) and the Council of Pharmaceutical Innovation (CIF) signed an agreement to address conflicts of interests between the industry and healthcare professionals. The agreement prohibits the provision of donations and gifts to influence healthcare professionals’ decisions and paying physicians to conduct clinical trials of new drugs. The Presidents of both organizations said they hoped the agreement would show the public they are serious about stopping conflicts of interest. The signing of the agreement comes in advance of a vote by the Chilean legislature on the Pharmacy Law which will bring transparency to the relationship between physicians and the industry.

The need for Rudolph’s shiny nose is starting to dwindle as the CMS starts clearing up some of the fog surrounding Sunshine requirements. Andrew Rosenberg of the CME Coalition met with CMS’ Sunshine implementation team to clarify some of the requirements related to reporting payments at CME events. He was able to confirm that events considered accredited under the final rule the following are exempt from reporting; speaker travel and lodging, attendee buffet style meals and most educational items. Rosenberg was pleased with the clarification, and said, “The goal here should be to continue to encourage doctors to pursue CME and not create a barrier for uncertainty about the rules.” The CME Coalition hopes to see CMS make changes regarding the accrediting bodies whose programs fall under the CME exemption in the final rule. Rosenberg points out there are number of other accrediting bodies that have adopted ACCME standards and follow the same rules as the organizations listed in the final rule. He also said that CME events supported by accrediting bodies with rules similar to CMS’ final Sunshine rules should be exempt from reporting. The Coalition plans to continue to push this point with CMS and Rosenberg believes eventually they will win on this issue.

Christmas may still be several months off, but the start of Sunshine Act data collection is just a few days away! It is essential that those who interact with physicians understand the requirements under Sunshine to avoid a “garbage in- garbage out” scenario with all necessary data. To ensure a clear understanding of Sunshine consider our customizable, off-the-shelf module. Click here to learn more about our effective eLearning program.

Unfortunately, we must wrap up our little holiday fantasy and return to the warm reality of summer. Have a great week everyone!