FCPA

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!

Week in Review, September 3, 2013

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

The PharmaCertify Team

September has finally arrived! While the temperature says summer is still upon us, fall sports are in full swing. The finale of MLB season is just a few short weeks away, college football opened with a bevy of thrilling games (we’re talking to you Clemson and Georgia fans!), and the much-anticipated NFL season begins this weekend. As you ponder the possibility of your team making a magical run at the 2014 Super Bowl in the league where they play for pay, we offer our picks for the News Week in Review.

We start with that new Titan of regulation in the pharmaceutical industry, the Sunshine Act. In a piece for MedCity News, Dr. Westby Fisher, reveals what he feels are some of the cloudier aspects of the law. Dr. Fisher doesn’t believe patients are really interested in scanning a database to learn what their doctor is receiving from pharmaceutical and device makers, and he points out that the government already holds much of the information on payments to doctors in the form of IRS 1099-R forms. He contends the Sunshine Act casts a light on interactions that have no effect on the costs of drugs and devices, while “back room deals” with insurers, which do have an effect on the costs of drugs and devices, continue.

A Pack of pharmaceutical companies are facing an antitrust lawsuit in Florida. The insurance trust fund of the Ft. Lauderdale Fraternal Order of Police is suing Medics and several other companies for actions that kept a generic version of an acne medication, Solodyn, from the marketplace. The suit contends that lead defendant, Medicis, filed a “sham” Citizen’s Petition with the FDA to delay the approval of the generic. The suit claims that Medics also created alternative versions of the product, in new strengths and had physicians write prescriptions for the new strengths. Impax Laboratories, Mylan and Sandoz are a few of the other companies named in the lawsuit.

All the recent publicity about bribery of Chinese doctors is hardly making the industry look like a bunch of Saints, but perhaps a piece of the puzzle is missing. According to some who work in the healthcare industry in China, Chinese companies, which control 70 percent of the market, are involved in the same behavior as the western companies, yet no Chinese company has been called to task. Analysts speculate that the Chinese government is targeting western companies in order to create a competitive advantage for the homegrown companies. Western companies in other industries, including automotive and technology, are facing scrutiny as well.

The FCPA is no longer the only Cowboy at the anti-corruption rodeo. Over the last several weeks, the Serious Fraud Office in the U.K. and Canadian courts have been busy with anti-corruption cases. The SFO brought its first charges stemming from the UK Bribery Act, and the Canadian Courts found an individual guilty of violating the Corruption of Foreign Public Officials Act. The risk of multiple prosecutions is more pressing than ever for global businesses.

An L.A. retailer may be feeling like a saucy fashion Buccaneer now, but the celebration may be short-lived. The retailer created a line of tee shirts featuring the names of several drugs made by manufactured like Pfizer, AbbVie and Shire. None of the manufacturers granted permission for the names of their drugs to be used on the t-shirts. Pfizer and Shire are considering options for dealing with the unauthorized use of their trademarks. AbbVie, expressed concern that the shirts trivialized the serious health conditions that its drug is meant to treat.

Well that’s it for this short workweek folks. As you plan your 2014 compliance training curriculum this fall, our mobile solutions can help you extend critical compliance content where your learners need it most – in the field and at their fingertips. Contact Sean Murphy at smurphy@nxlevelsolutions.com for a demo.

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 19, 2013

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

The PharmaCertify Team

Can you hear it? That low wail that’s bound to grow stronger over the next few weeks. Yes, it’s the cry of school children everywhere, as the end of summer vacation creeps closer. Yellow buses will soon populate the roadways, and the odor of freshly-sharpened number two pencils will fill the air… a wonderful time of year (unless of course you happen to be under the age of 18)! With those happy thoughts, let’s ring the bell on this week’s News Week in Review.

A new anti-corruption lesson plan is about to take effect in Brazil. The country’s president signed a new anti-corruption law that increases the country’s corruption prohibitions. The law imposes liability on corporate violators and increases fines, which can now be up to 20% of the violator’s gross revenue for the preceding year. The law, which covers corrupt payments to foreign or domestic officials, goes into effect at the beginning of 2014.

The Serious Fraud Office (SFO) appears to be handing out failing grades with the filing of the first charges under the U.K. Bribery Act. The agency filed fraud charges against four men for providing false information related to the selling of bio fuel investment products. The fraud is alleged to have occurred between April of 2011 and February of 2012, to the tune of 23 million pounds.

Time for some serious homework at SciClone, Inc. The company announced it had received a new subpoena in an ongoing investigation into potential violations of the FCPA. The subpoena was received in the last quarter of 2012. Both the DOJ and SEC have been investigating the company over operations in China since 2010. The company did not disclose the particulars of the latest subpoena, but did announce its board had opened a new investigation into matters related to the company’s acquisition of NovaMed Pharmaceuticals, FCPA violations and certain sales and marketing expenses.

Corporate employees are taking their hall monitor duties very seriously. According to a report from the Network and BDO Consulting, use of the company hotline has been steadily rising over the last two years for most companies. The report evaluated over 600,000 hotline incident reports from 2008 to 2012. The companies were divided into five groups, based on number of employees. Only the group made up of companies of 20,000 – 50,000 employees saw a decrease in incident rate. The report also showed that 72% of the people who made a report via a hotline did not report the issue to a manager first.

Transparency tutoring is now available from the Association of the British Pharmaceutical Industry (APBI). The group has launched a toolkit to help its members comply with the requirements for disclosing information from or about clinical studies. The toolkit, which includes practice guidelines, disclosure checklists and a template SO, will be updated regularly to include changing international requirements.

The final bell is about to ring on this week’s Review, but before we dismiss ourselves, we ask, have you thought about re-evaluating your compliance “lesson plans?” As the summer ends, this is a great time to think about new ways to engage you’re your learners with fresh compliance content and innovative training techniques.

Have a great week every one!

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!

Week in Review, July 22, 2013

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

The PharmaCertify™ Team

Apparently, the British media nicknamed Kate Middleton “Waity Katie” while she waited on Prince William to pop the question, and she proved to live up to that nickname again while she and her prince waited on the arrival of their first born. The waiting is finally over! As of press time, the Duchess of Cambridge was in labor. While the world waits to learn if the third in line for the throne is a boy or a girl, we’ll help you pass the time with this week’s News Week in Review.

With Sunshine’s due date quickly approaching, CMS released more FAQs and a couple of apps to help track payments. The latest additions cover the definition of an accredited CME program, and how (sort of) payments to physicians for promotional speaking engagements should be categorized. As to the latter question, CMS states those payments could be categorized as “honoraria” or “payments for services other than consulting,” depending on the ”specific facts.” Hmm…that’s helpful. The apps are available for industry professionals or physicians and are primarily designed to help with the payment tracking process.

The Journal of the American Medical Association has a gift for those submitting studies for publication. JAMA will no longer require independent statistical analysis for clinical studies funded by the industry. JAMA’s editor-in-chief cited improvements clinical trial reporting, including clinical trial registries and more transparency in trial data, as the reason for dropping the requirement.

There’s a new arrival in the Pennsylvania legislature. A bill has been introduced to institute a state false claims act. The bill has many of the same provisions as the federal False Claims Act, including protection and incentives for whistleblowers.

On the bribery front, China has been the focus of a number of bribery investigations in all business sectors, with the pharmaceutical industry taking center stage. The focus has been on GSK to this point, but several other pharmaceutical companies are under investigation by Chinese law enforcement, prompting one multinational company to tell employees in China to choose compliance with Chinese regulations over winning business. The regulatory climate, poorly paid doctors, and underfunded hospitals have fueled the fire for bribery in China, and made the industry a target for enforcement agencies. Chinese officials may also have another reason for focusing on the industry – the rising cost of healthcare in the country. Those costs are expected to top one trillion dollars by 2020.

Canada has decided to dress up its anti-bribery law with new amendments designed to strengthen the law. The amendments make it easier to investigate and prosecute offenses, and exposes corporate directors, officers and employees to expanded criminal liability. A criminal books and records offense (a civil offense under the FCPA) was added, as was a provision for phasing out facilitation payments. The maximum penalty for individuals was increased from 5 to 14 years imprisonment.

US law enforcement delivered multiples last week; multiple settlement announcements that is.  Amgen agreed to pay $15 million to settle allegations it violated the federal Anti-kickback Statute and False Claims Act. According to prosecutors, the company used data purchase agreements to incentivize oncologists to use one of its chemotherapy drugs. Mallinckdrot Inc. also agreed to pay $3.5 million to settle allegations of violating the Anti-kickback Statute and False Claims Act.  The company was accused of incentivizing doctors to prescribe “outdated and third-rate drugs.” The whistleblower suit claimed the company paid speaking and consulting fees to physicians in exchange for prescribing its anti-depressants and sleeping pills. The suit claimed that without the incentives, the drugs would not have been prescribed, since several of the drugs were approved decades ago.

Well, that’s about it on the news front for this week. As people around the world monitor their mobile devices for news of the royal delivery, we’ll use this opportunity to ask if you’ve incorporated mobile solutions into your compliance plan. PharmaCertify’s mobile apps and iPad-compatible training modules bring critical compliance content where your staff where they need it most – in the field and at their fingertips. For more information or a demo, contact Sean Murphy at 609-466-2828, ext 25 or smurphy@nxlevelsolutions.com.

Have a great week everyone!

Week in Review, July 8, 2013

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

Te PharmaCertify™ Team

Well, here we are again…Monday already. Back to work we go, after what was hopefully a long weekend for you. While having one or two days off is refreshing, it tends to leave you a little foggy on Monday, doesn’t it? Never fear, we kept our ear to the ground throughout the July 4th holiday and what better way to jump start the week than with the News in Review.

A study finds that Canadian medical schools’ policies about interactions with industry are falling short. The study evaluated the conflict of interest policies of Canada’s seventeen medical schools in twelve categories, including samples, curriculum and scholarships. In most of the categories, only one school had what researchers considered restrictive policies. Some of the schools have developed new polices or revised existing policies since the study was conducted in 2011.

Bribery is no small matter, and a new report finds that bribery and corruption risks are on the rise. Nearly half of the businesses in the study say their bribery and corruption risks have increased in the last two years, and they expect that trend to continue in the future. Expansion into new markets and heightened enforcement are the top two reasons cited for the increase in risk. Nearly 20% of the businesses in the study said they either don’t require employees to read their anti-bribery policy or they don’t even have one in place.

Several GSK employees were detained by Chinese officials for suspected “economic crimes.” The detention follows allegations from an internal tipster. The company said it was aware of an investigation by Chinese officials, but the nature of the investigation was not known.

The London Police will soon start training businesses about the UK Bribery Act. The training, which is slated to begin in September, will be conducted in conjunction with the British Standards Institution, a business standards company. The London Police have 25 bribery cases under investigation.

Transparency is going global, as the European Federation of Pharmaceutical Industries and Associations (EFPIA) is now requiring its member companies to disclose payments and transfers of value to physicians. The requirement was adopted by the EFPIA’s board last month, and will require member companies to begin publishing the information in 2016.

Medical device manufacturer, Baxano Surgical, formerly TransS1 Inc., agreed to pay $6 million to settle allegations it violated the False Claims Act. The company was accused of causing healthcare providers to submit incorrect diagnosis or procedure codes to Medicare for the use of its spinal fusion products. The government claims the company advised providers to use a code intended for more invasive spinal procedures than those associated with use of the their own product. The company was also accused of providing kickbacks to physicians in the form of consulting and speakers fees as an inducement to use its product, and for promoting the product for unapproved uses.

The settlements for violations of global bribery law are growing in numbers and dollars. That’s why PharmaCertify’s, Understanding and Preventing Bribery in the Global Life Sciences Marketplace is designed to help your staff and representatives evaluate the degree of risk inherent with every transaction and understand the level of due diligence and monitoring needed to ensure compliance with the FCPA and the UK Bribery Act. Contact Sean Murphy at smurphy@nxlevelsolutions.com to learn more about the module.

Have a great week everyone!

Week in Review, July 1, 2013

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

The PharmaCertify™ Team

Strike up the band, fire up the barbecue and prepare to proudly fly the flag high! It’s almost Independence Day; the time of year when, despite our differences, Americans come together to celebrate the birth of our nation. But before we find the best spot on the curb to watch the parade pass by, there is still the matter of the work week, albeit a short one. What better way to get us started, than with the News Week in Review.

The US Supreme Court has certainly been busy. In a 5-4 decision, the Court decided that a federal law regarding pharmaceutical promotion pre-empts a person’s ability to file a state suit over a poorly designed generic drug. The case involved a woman who sued Mutual Pharmaceuticals after she suffered an adverse event allegedly caused by one of the company’s generic products.

The British are coming! The British are coming! And they’re serious about anti-bribery. Speaking at an anti-corruption conference, the Serious Fraud Office’s chief investigating officer, Kevin Davis, revealed the organization is actively investigating two cases under the UK Bribery Act. Despite drastic reductions in the SFO’s budget, Davis said cost would not deter the SFO from pursuing bribery cases, and stressed the importance of companies having robust procedures in place to deal with bribery. Davis also discussed the shift in the SFO’s approach to handling bribery cases. He told conference attendees, “We are not an agony aunt or advice service. The SFO had tipped too far towards settlements.”

Medicines Australia took another step toward joining the transparency parade. The agency’s Transparency Working Group released its model for reporting physician payments. The model is similar to the US Sunshine Act, and is currently being reviewed by the larger organization.

John Hancock would be a bit disappointed with recent petition response from the FDA. The agency was petitioned by a non-profit group to increase the type size on DTC ads. The group is concerned that the type is too small for the elderly to read and they are hopeful that a change will reduce accidental overdose and adverse events. The FDA rejected the petition, saying while the concerns are valid, current regulations and two draft guidance policies address the issue satisfactorily. The group was disappointed with the decision, saying that the FDA had turned “its back on millions of patients and consumers nationwide.”

Medtronic declared its independence from an FCPA investigation. In a regulatory filing, the company said it was informed by the SEC and DOJ that the agencies would not be prosecuting the company on FCPA charges. In 2007, the company received letters from both agencies, seeking information on potential violations of the bribery law.

Well, that’s it for this week’s Review. Amidst your plans for the weekend celebration, it’s easy to forget that we are now under the 30 day mark for Sunshine Act data collection to begin. PharmaCertify’s The Sunshine Act: The Federal Physician Spend Disclosure Law covers the reporting requirements and includes practical tips for tracking and reporting crucial spend data.

Have a great week and July 4th celebration!

Week in Review, June 24, 2013

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

The PharmaCertify™ Team

According to the meteorologists and the astronomers, summer has begun! Time to hang ten and catch a wave! We know…on a Monday, the weekend beach time seems a little far off, but at least we can dream, as we enjoy an iced coffee or other beverage of choice. Before you drift off to the shores of daydream land though, check out what the tide brought in…this week’s News Week in Review.

According to one congressional report, it’s not just sand dollars the FDA is holding onto recently. The US House Committee on Appropriations criticized the agency for carrying one billion dollars of unobligated user fees halfway through the fiscal year. Congress expected some carryover in user fees, but the one billion dollar figure was quite the surprise. Going forward, the FDA Commissioner will submit a report about the fees to the Appropriations Committees and what programs those fees will support.

A new report finds that objections from regulatory departments are not the reason pharma companies are slow to catch the social medial wave. When asked about the social media mindset at the end of 2012, twelve pharmaceutical executives said the biggest obstacles were teamwork issues. The executives pointed to a lack of internal expertise in social media and an unwillingness to participate by various groups within the organization. An inability to measure the return on investment was also cited.

Efforts at passing legislation similar to the Sunshine Act have wiped out in Australia. The Australian Senate Finance and Public Administration Legislation Committee rejected a bill that would have required disclosure of physician payments by pharmaceutical manufacturers. Instead, the committee agreed with industry and medical professional stakeholders in stating that self-regulation was a better way to handle the disclosures. Some believe that the bill failed because Medicines Australia is currently working on payment transparency requirements, which has limited the scope of the bill.

In the world of generics, the U.S. Supreme Court has ruled that companies can be sued over pay for delay deals that slow the entry of generic drugs into the market. According to the Federal Trade Commission (FTC), the delays cost consumers $3.5 billion a year. The decision opens drug companies to a wave of suits by wholesalers, insurers and antitrust enforcement agencies.

CMS want physicians to know the agency is dedicated to making sure they don’t get burned by Sunshine. A spokesperson from CMS told a gathering of the American Medical Association’s House of Delegates that data accuracy is the agency’s top priority.  The spokesperson said doctors can challenge the information if they feel it is inaccurate, and she encouraged them to take an active role in the process. CMS is developing tools, like a smart phone app that syncs with manufacturer reporting activity, for physicians to monitor the process and dispute results. The outgoing AMA president said the Association has started a Sunshine resource page to educate physicians about the requirements of the laws and will be holding webinars and hosting online modules for additional assistance.

It’s not all sunny skies concerning data accuracy at CMS. According to a report from the OIG, the database housing the physician information required for the Sunshine reports is largely inaccurate. Apparently, the National Plan and Provider Enumeration System (NPPES), which houses National Provider Identifiers (NPIs), contains inaccurate information in at least one field, 48% of the time. The OIG made several recommendations to correct the problem, including the implementation of program integrity safeguards in the Program Integrity Manual.

Well. that’s it for “start of summer 2013” edition of the News in Review. If the Sunshine Act is hot on your list of training topics for 2013, PharmaCertify has added The Sunshine Act: The Federal Spend Disclosure Law to its curriculum of customizable off-the-shelf compliance training modules. Contact Sean Murphy smurphy@nxlevelsolutions.com to learn more or receive a content outline.

Have a great week everyone!