HIPAA

Week in Review, May 5, 2014

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UCLA settles with a surgeon over conflicts of interest, CMS announces a timeframe for Phase 2 of Open Payments data submission, qui tam lawyers pour through the recently released Medicare payment data and PhRMA weighs in on simplifying product warning information.

Not so long ago in a galaxy…well, right here…the greatest achievement in cinema was celebrated (yes, we’ll admit it, we’re often given to hyperbole). With all due respect to Bogie and Bacall and Orson Welles, we’re of course referring to this past weekend when the Fourth of May was with us, and we celebrated Star Wars Day. Then, on Monday we had to deal with the Revenge of the Fifth. Rather fitting don’t you think? If Star Wars isn’t your particular cup of blue milk, feel free to jump right to the earthly compliance news of the week with this issue of the News in Review.

10,000 credits in advance may get you a ride on the Millennium Falcon, but it took 10 million dollars to settle a retaliation suit between a UCLA surgeon and the University of California Board of Regents. The surgeon, who was head of the orthopedic surgery department, raised concerns about physicians’ financial relationships with medical device companies. He claims his complaints were ignored and he was then denied patient referrals and prevented from participating in grants. In settling, UCLA claims it chose “to end a prolonged conflict and permit UCLA Health Sciences to refocus on its primary missions of teaching, research, patient care and community engagement.”

Open Payments: Episode 2, coming soon to an industry company near you. CMS has announced that applicable manufacturers can expect Phase 2 of Open Payments data submission to be open late May or early June. During Phase 2, applicable manufacturers and GPOs should:

  • Register any authorized officials not registered during Phase 1
  • Complete the registration for entity and the authorized official (supplemental information is required)
  • Verify entity profile information is correct
  • Upload, verify and attest to accuracy of payment data

Additional roles within the Open Payments system may also be assigned during Phase 2. CMS is preparing tutorial videos to assist applicable manufacturers and GPOs with implementation.

Qui tam lawyers have been mining the recently released Medicare payment data almost as aggressively as the Empire mined the Tibanna gas mines at Bespin (wow, we went full out geek there). The organization known as Taxpayers Against Fraud has lawyers pouring through the data looking for physicians who prescribe high numbers of a particular product. Obtaining this type of data previously required a subpoena. Is this a foreshadowing of what to expect once Sunshine data is released? Sunshine data might be used to demonstrate alleged instances of kickbacks, or infer that a company is involved in off-label marketing when a physician’s specialty doesn’t align with the approved use of a product.

They may not be well-liked by the hard core fans, but the Ewoks certainly proved the power of “keeping it simple.” Seriously, a bunch of teddy bears held off the Empire with rocks and logs! PhRMA appears to share this simplicity sentiment when it comes to the warnings in DTC ads. When the FDA asked for comments regarding a study focused on whether simplified warning information would help patients better understand the risks, PhRMA didn’t hesitate to voice its opinion. The organization believes shorter or less-complex warnings would help patients understanding the risks and motivate patients and healthcare providers to seek additional information about the drug.

With Phase 2 of Open Payments registration and data submission about to begin and the data publication expected not too far in the distant future, the Sunshine Act is burning brighter than the two suns of Tatooine. Make sure your team understands the nuances of the law The Sunshine Act: The Federal Physician Spend and Disclosure Law from the PharmaCertify™ suite of off-the-shelf eLearning modules.

Well folks that brings us to the end of this episode. Have a great week, and may the Force be with you!

Week in Review, April 29, 2014

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Pakistan joins the transparency parade, Arkansas’ Supreme Court won’t reverse the Risperdal decision, one Google executive wonders why pharmaceutical companies aren’t using YouTube more, and the DOJ offers a reminder about the need for a proactive approach to compliance.

California Chrome. Vicar’s in Trouble. Wicked Strong. Titles to obscure B movies? Nope, they’re just some of the participants in the “greatest two minutes in sports.” The countdown is on to the Kentucky Derby! We have less than a week to polish up those mint julep cups and shop for that perfectly obnoxious large hat. In the meantime, sound the call to the post, it’s time for the News Week in Review.

First out of the gate is the news that Pakistan is considering physician-industry interaction transparency requirements. The Drug Regulatory Authority of Pakistan is driving the increased transparency initiative and Pharma Bureau, a trade group of multinational industry companies operating in Pakistan, welcomes the move. The Bureau sees consistent guidelines and enforcement as a step toward better patient care and an improvement in the industry’s image.

According to a new study, doctors who don’t accept drug samples are a long shot to prescribe branded drugs. The study, published in JAMA Dermatology, compared offices in an academic medical center, where samples are not permitted, to private practice offices that do accept samples. Only 17% of the prescriptions written for adult acne drugs in the academic centers were for branded drugs, compared to 79% of the scripts being written for branded drugs in the private offices.

No Big Bazinga from the Arkansas Supreme Court regarding its reversal of the Risperdal verdict. In a 4-3 decision, the court said it would not reconsider its March decision to overturn the verdict. The verdict was overturned when the court said the state’s Medical Fraud False Claims Act did not apply to the Risperdal manufacturer because the law was codified in way that conflicted with the intent of the law. Arkansas Attorney General Dustin McDaniel asked for the ruling to be reconsidered because the issue of how the law was codified was not raised but the state or the drug manufacturer.

The folks at Google think pharmaceutical companies could benefit from a little more Social Inclusion. The head of Google’s healthcare-focused digital marketing team, David Blair, says the industry could utilize YouTube more effectively. Online viewership has now eclipsed television, and according to Blair, one-third of You Tube users share what they watch. YouTube is also the second largest search engine behind Google and Blair believes pharmaceutical companies are missing an opportunity to make an emotional connection through a disease awareness video or wellness campaign.

According to experts speaking at the Dow Jones Global Compliance Symposium, companies should set an aggressive pace when scrutinizing their own compliance programs. A deputy attorney general from the DOJ told attendees at the Symposium that companies are too quick to claim the problem only involved a few employees and that’s one of the first signs of a weak compliance department. Attendees also learned that the U.K., Canada and Germany have all set up units similar to the DOJ’s FCPA unit.

That’s going to bring us to the finish line for this week’s News in Review. We’ll see you right back here next week with another summary of the news from the world of life sciences compliance. As always, thank you for reading and have a great week!

Week in Review, April 21, 2014

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The European Federation of Pharmaceutical Industries and Associations increases its education efforts, GSK conducts internal bribery investigations, FCPA experts warn of increasing scrutiny and some restaurants look for creative solutions to changing pharmaceutical company requirements.

May is almost upon us, and you know what that means…so is the summer movie season! It’s a time marked by seemingly endless blockbusters and family movies, released on a weekly basis. Captain America: The Winter Soldier “sort of” represented the unofficial start of the season, and in a matter of weeks, the parade of superhero, wacky comedies, sci-fi thrillers and animated family films will begin in earnest. Hollywood’s big blockbuster may be still be a week or two away, but we have a little entertainment of our own to share, with this week’s News in Review.

Coming soon to a global theater near you: physician payment disclosure. The European Federation of Pharmaceutical Industries and Associations (EFPIA) is rolling out an education program to help companies prepare for its financial disclosure requirements. In January, companies will have to collect, and subsequently disclose, payments made to healthcare professionals and healthcare organizations. The education program, which will include webinars, leaflets and videos, will focus on current best practices and highlight how companies across Europe are preparing for the disclosures.

Look for sequels to be a popular choice for audiences this summer (How to Train Your Dragon 2, 22 Jump Street), but don’t expect GSK to be excited about another sequel on the anti-bribery front. Polish authorities are accusing the company of bribery, and the company has launched an investigation into bribery allegations in Jordan and Lebanon. In Poland, the company is accused of paying doctors for prescriptions, and disguising the payments as speaker fees. According to Polish authorities, a dozen doctors were paid fees for presentations they never delivered. GSK conducted its own investigation, saying the payments seem to be linked to one employee and that employee has been disciplined.

In Jordan and Lebanon, GSK began investigating allegations of bribery after a whistleblower contacted the company. The investigation is focused on allegations that bogus speaker fees were paid to physicians; free product was offered for the physicians to sell to patients; and a physician was allowed to exchange a business class plane ticket economy class tickets so his family could accompany him to a medical conference.

Corporations should expect even more focus on FCPA enforcement this summer and in coming years, especially now that global agencies are pooling enforcement resources. Speaking at a conference of the New York City Bar Association, two former government fraud officials, one formerly with the SEC and one formerly with the DOJ, warned that the two agencies are adding to the penalties if companies don’t cooperate with the investigations or try to obstruct the process.

Senator Grassley is planning a new whistleblower production and he is turning to his colleagues for help. The Senator announced he intends to form a Senate Whistleblower Protection Caucus to help ensure whistleblower protection laws are enforced. The plan is to recruit colleagues for the caucus throughout the year, with the goal of launching the new production at the start of the new Congress.

The rules on providing food for pharmaceutical and medical device company meetings have changed, but rather than walk away from the business, some restaurants, like Fogo de Chao, are taking a more creative approach. Leo Jakobson, editor for Successful Meetings, says the Brazilian steakhouse keeps the menus modest and informal by focusing on meals served on skewers, and all of the locations offer private dining rooms for up to 120 participants.

And that’s almost a wrap…at least for this version of the News in Review. The summer season is a great time to reconsider the impact your compliance training has had on your audience. Compliance rules, guidance and best practices are evolving, and we’re expanding the PharmaCertify™ list of mobile training solutions to keep pace with those changes. Through the release of new titles, like Understanding Global Physician Spend Transparency, and updates to existing modules like The Sunshine Act: The Federal Physician Spend Disclosure Law, PharmaCeritfy™ offers the training where your reps need it most – in the field and at their fingertips.

Have a great week everyone! We’ll see you at the movies.

News Week in Review, April 15, 2014

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Wisconsin seeks to harmonize health records, a Vermont legislator wants an exemption for the medical device industry, and the pharmaceutical industry questions how much Sunshine has had an impact on relationships with physicians (so far).

The birds are signing, the grass is a vibrant green, the flowers are blooming…it must be time for the Super Bowl…of golf that is. The Masters, “a tradition unlike any other,” and the big daddy of all professional golf tournaments, was held in beautiful Augusta amid the standard back 9 meltdowns and whispers up and down the greens. With his usual breathtakingly long drives and birdies on 8 and 9, Bubba Watson fought off the young phenom, Jordan Spieth, to win his second green jacket. But enough about divots and drivers, tee time for this week’s News in Review is here.

In the words of the great Ty Webb, “be the ball.” It’s all about harmonization, right? Well, the governor of Wisconsin certainly thinks so. Governor Scott Walker signed a bill into law that will harmonize the state’s law regarding behavioral health records with the HIPAA Privacy Rule.

A Vermont physician and legislator, George Till, would like to take a mulligan (of sorts) on the state’s physician gift ban law. He has introduced a bill in to the state’s legislature for an exemption to allow medical device companies to provide food and drink to doctors at seminars and other events sponsored by medical device companies. According to Till, physicians really need to have a “hands on” experience to familiarize themselves with a medical device. Till is a supporter of the state’s gift ban, and he doesn’t believe that his bill is in opposition to the principle of the law.

Are conflicts of interest the sand trap of the CME world? At a meeting of the American College of Cardiology, ACCME president, Murray Kopelow, spoke about the ACCME’s conflict of interest requirements. Kopelow said the ACCME is “very precise” about determining when a conflict of interest exists. The organization evaluates whether the individual: a) has a financial relationship with a defined commercial interest and b) has the ability to control the content of CME relevant to that relationship. The content of accredited CME must be valid and free of commercial interest as defined by the ACCME. Kopelow is concerned about criticisms that ACCME’s standards are hindering innovation. He says this was not the intention and special guidance has been created for those working in discovery.

Takeda and Lilly were recently assessed one heck of a penalty stroke. The two companies were ordered to pay $9 billion by a federal jury for failure to disclose the cancer risks associated with use of the drug Actos.

The FDA is not quite sure what approach to take to the proposed safety prediction and mining tool intended to help assess drug adverse event safety signals. The project was initially announced in April of 2013, but by September it was put on hold due to funding concerns. On March 31 of this year, the FDA again announced it was again looking for an outside partner for the project, but just three days later they changed their minds. The agency provided no reasoning for the latest cancellation, only saying that it would “re-advertise the contract solicitation at a later date.”

What would a Week in Review be without one story about the Sunshine Act? During PhRMA’s annual meeting, leaders from various companies said the Act was having no effect on how their companies interact with physicians. While doctors have not shut the door on the industry, Bob Hugin, PhRMA’s board chair, is concerned that once published, the Sunshine data could be mischaracterized by the public and cause the physicians to reconsider how they do business with the industry. Hugin says companies must take a proactive approach to ensure the data is presented in the correct context.

As we approach the 18th green for this issue of the Week in Review, we’ll finish with a brief word about the expanding curriculum of PharmaCertify™ compliance training solutions. If global transparency is on your radar, we are adding Understanding Global Physician Spend to our lineup of customizable off-the-shelf eLearning modules. The module covers the EFPIA Code of Transfers of Value, as well as specific country laws, like the French Sunshine Act. Contact Sean Murphy at smurphy@nxlevelsolutions.com for more information and to see a content outline.

Have a great week everyone!

News Week in Review, April 8, 2014

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China shifts its focus to medical device, the Arkansas Attorney General petitions the state’s Supreme Court to reconsider its reversal of the Risperdal verdict, GSK dismisses employees for violating expense rules, and a new study raises questions about conflicts of interests for medical school leaders sitting on the boards of pharmaceutical companies.

Ah yes, the glittering dresses, the suave tuxes, the perfectly coifed hair. No, we’re not talking about the Academy Awards or the Golden Globes, this is much more important than all that. It’s almost prom season!

If your Facebook, Twitter or Instagram isn’t littered with pictures of your kids and their cronies in their formal finery yet, it’s just a matter of weeks. You can take some small amount of solace knowing all those happy smiling faces will one day be questioning their choice of fashion or hairstyle. C’mon, you know you did. (Let’s just say there were some very unfortunate prom fashion choices made in the 70’s and 80’s by members of the News Week in Review staff.) As we wax poetic about proms of yore, let’s also look back at the compliance week that was, in this week’s News Week in Review.

First on the dance floor is news that China intends to toughen penalties for corporate malpractice against medical device companies. The country will segment devices into three categories based on their potential risk to consumers. The new rules are set to take effect in June, and the top fine for selling illegal medical devices will increase to 20 times the value of the device.

Not wanting to feel like a wallflower, the Attorney General of Arkansas is asking the state’s Supreme Court to reconsider its reversal of the $1.2 billion verdict in the Risperdal case. The court ruled the state had misapplied the state Medicaid fraud law when it tossed the verdict, and even said the law was codified incorrectly. The Arkansas Code Revision Commission voted to provide the AG with an analysis comparing the law as written to how it was written into Code. The AG says the analysis may be helpful in obtaining a new hearing.

The chaperones seem to be working hard at GSK. The company has dismissed several individuals for violating company expense rules. The company did not comment on the number of individuals involved, but did say monitoring efforts in China have increased, and that irregularities are always investigated. Emails reviewed by the Wall Street Journal indicate the company is also investigating allegations of bribery in the Middle East. The emails focus on activities occurring in Iraq, including the hiring of state employed doctors as medical representatives while those doctors were still working for the government.

A former GSK sales representative in China tells the Financial Times that kickbacks to doctors there were widespread. According to the former rep, domestic and foreign firms routinely paid kickbacks to doctors to achieve their sales targets, and the sales model at GSK was no different than those of its competitors. GSK called the behavior “completely unacceptable,” but as AstraZeneca’s CEO pointed out, even a tough compliance program can’t stop an employee determined to stray.

A new study finds that the leaders of medical schools and hospitals are being paid handsomely for sitting on the boards of pharmaceutical companies. The study found that of the 50 largest companies, 40% had at least one board member who was in a position of leadership at an academic medical facility. The average total compensation for these individuals was over $300k per year. The study raises the potential for a conflict of interest. For example, the president of Yale’s medical school receives nearly $300k from Abbott, but a spokesperson from Yale says the doctor would not make decisions about formularies, clinical trials, or drug samples, when Abbott is involved. Several other medical schools made similar comments regarding leaders of their medical facilities who receive compensation from pharmaceutical companies.

As we cue the last song on this week’s playlist, we’ll take this opportunity to let you know the PharmaCertify™ list of compliance modules and mobile apps is expanding. If global transparency, including the EFPIA Code and French Sunshine Act, is on your radar, we’ve added Understanding Global Physician Spend Transparency to our curriculum of customizable eLearning modules. To learn more about the module, or any of topics, contact Sean Murphy at (609) 466-2828, ext. 25.

Have a great week everyone.

Week in Review, March 17, 2014

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In this issue…a look back on Caronia and its impact (if any), China cracks down on medical device websites, Teva settles improper allegations involving one of its subsidiaries and the FDA chastises one company for its product claims on Facebook.

Top o’ the morning, afternoon and evening to you! This may be the Ides of March, but we’ll put that aside and focus on the fun of St. Patrick’s Day instead. If this is March 17th, spring must be right around the corner and this must be Lá Fhéile Pádraig! Hopefully, you wore enough green today to avoid the pinch of those dastardly leprechauns. Pass the corned beef and cabbage, cue the bagpipes and straighten your kilts…it’s time for this week’s O’News in Review!

More than a year has passed since the Caronia decision, but it hasn’t exactly been the lucky charm some thought it would be for the industry. The decision supported the argument that truthful, non-misleading statements regarding off-label uses were protected by the First Amendment. However, the government distinguishes the application of the decision as it applies to the Food, Drug, and Cosmetics Act from how it applies to the False Claims Act (FCA). The government has argued that Caronia has no bearing on cases brought under the FCA because the Act applies to any conduct, including off-label promotion, that results in the submission of a false claim being submitted. For the foreseeable future at least, the government is as committed as always to pursue cases involving off-label promotion.

The Chinese government thinks that some medical device websites have taken the gift of gab a bit too far. The country’s State Food and Drug Authority has reported ten websites to the authorities for publishing false information about medical devices. The discovery is particularly concerning to the global med tech industry since several of the sites have allegedly forged the names of medical device manufacturers and posted fake equipment.

Teva Pharmaceuticals, Ltd. has agreed to part with a wee bit o’ green ($27.6 million) to settle allegations that one of their subsidiaries made improper payments to a physician.  According to the government, the Teva subsidiary, IVAX, funded vacations to Miami for the doctor, his family, friends and staff. The doctor is facing civil charges in Illinois federal court.

Closing the discrepancy between what medical device manufacturers report for physician spend and what those physicians disclosed may take more than just a little luck, according to a new study by Yale. The study compared the spend disclosures posted on the Medtronic and DePuy websites against what the physicians had disclosed. More than half of the information on Medtronic’s website was not in line with what the physicians reported and the discrepancy rate at DePuy was 30%. The study’s director says the errors go both ways, and he is concerned the public will assume that physicians are trying to hide something when that is not the case.

The International Society of Medical Publication Professionals has reevaluated its recommendations regarding support for medical publications and Sunshine reporting. In its previous recommendation, the organization suggested that all support from an applicable manufacturer was reportable. Now it recommends members consider who would benefit from the publication. For example, if the support provided by the manufacturer helps an author publish a study that the manufacturer would have an ethical obligation to publish anyway, then that support is not reportable.

The FDA has issued an Untitled Letter to a pharmaceutical manufacturer over content on the company’s Facebook page. According to the letter, statements on the page touted the benefits of the drug without revealing any of the risks. In addition to failing to report potential risks, the company omitted important “approved use” information from the product label.

With that, we end this emerald edition of the News in Review. While the celebration of St. Patrick may be filled with talk of good luck and the proverbial pot of gold, compliance training is not something you want to leave to chance. That’s why our PharmaCertify™ suite of off-the-shelf modules cover the critical topics, like on-label promotion and the Sunshine Act, your colleagues need to integrate good promotional practices into their daily activities.

Have a great week everyone!

News Week in Review, March 10, 2014

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Pharmaceutical companies cut spending on physician speakers,  the DOJ turns up the HEAT, China ups the stakes on the bribery front, and the value of a reprint under Sunshine is still unclear.

Hey, wake up! The transition to Daylight Saving Time is such a drag…on our energy that is. Soon enough, we’ll all be excited about the extra daylight hours, but right now, we’d settle for some extra caffeine. To help you find your set point and adjust your internal clock, we offer our regularly scheduled overview of all things compliance…with this week’s News in Review.

The amount pharmaceutical companies spend on physician speakers is not exactly spring forward, according to an analysis of Pro Publica data. In fact, several large companies have dramatically cut spending on physician speakers, which some attribute to the transparency requirements of Sunshine. The companies offer a different rationale though. A spokesperson for Lilly says educational programs are of most value when a product is launched, or new clinical data is released. Additionally, as web conferencing increases, the need for speakers declines. A spokesperson for Pfizer points out that as blockbuster drugs go off patent and face generic competition, the need for educational programs and speakers for those drugs wanes.

Spending on drug marketing is on the rise in Washington D.C., according to a report by the George Washington University School of Public Health and Health Services. In 2012, companies spent $97.5 million on drug marketing, which represented the first year-on-year increase since 2007.

As spring draws near, and the temperatures rise, the DOJ continues to provide some HEAT of its own with the Health Care Fraud Prevention and Enforcement Action Team (HEAT) initiative. Using the False Claims Act as its primary tool, the agency has recovered $13.4 billion from individual providers, pharmaceutical companies, and medical device companies.

Takeda would like to turn back time after the company admitted using “inappropriate expressions” in an advertisement for its hypertension drug, Blopress, in Japan. A Japanese physician noticed that data presented in the advertisement was not consistent with the results of a head-to-head study with a competitor’s product. The company admitted that using a graph from a 2006 study in the advertisement could have caused confusion.

Speaking of losing sleep, life science executives may be lying in bed at night thinking about the increasing challenges of doing business in China. Officials in China announced that companies found to have committed bribery will be blacklisted and updated the country’s “Rules on the Establishment of Commercial Bribery Blacklists for Purchase and Distribution in the Health Care Industry.” Circular No. 50, which delineates the updates to the rules, states that a company may be blacklisted for several reasons, including minor instances of bribery that are not prosecuted by authorities. If blacklisted, hospitals and other facilities will be prohibited from purchasing goods in the province where the bribery occurred for two years. Companies blacklisted two or more times in five years will be prohibited from selling its products in the country all together.

A new study shows drug makers are not quite ready to crawl out from under the covers when it comes to using social media for clinical studies. The study conducted by the Tufts Center for the Study of Drug Development (CSDD) found that companies using social media in the clinical research process are doing so in a “siloed and experimental fashion.”  Lack of guidance from the FDA and concerns about the impact of social media on study integrity are cited as factors slowing the adoption of social media for clinical trials.

What’s a Daylight Saving Time theme without at least one reference to Sunshine. With little in the way of guidance from CMS, companies are taking various approaches to determining the value of journal reprints under the Sunshine Act. Some companies follow what CMS has stated, and value a reprint at the cost the company paid to acquire it from a publisher. Other companies use a blended average model and some hire a third party to determine the value of their reprints. Complicating the matter further, doctors are starting to refuse reprints because they see them as taxable form of income.

As the sun sets much later in the day, and on this week’s News in Review, we close with a reminder that the PharmaCertify™ online learning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, covers the topics your learners need to understand, like disclosure requirements and excluded payments, to stay abreast of this industry-changing legislation.

Have a bright and sunny week everyone!

News Week in Review, February 24, 2014

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A survey shows anti-bribery policies may not be working in Asian-Pacific companies, businesses are again reminded to keep an eye on third party intermediaries in regard to the FCPA, two pharmaceutical companies settle anti-competition charges and West Virginia institutes its own false claims act.

Well, did you set aside any time to indulge in one of the great spectacles in sports over the weekend? We’re not referring to the closing ceremonies of the Olympics, but the 55th running of the Daytona 500…the Super Bowl of racing! While it does seem a little odd to have the big “game” at the beginning of the season, we’ll roll with it anyway. (See what we did there? Roll with it.) Just like in the Olympics, the weather added some stress, but eventually, the race was completed and Dale Earnhart Jr. celebrated his win not by announcing he was going to Disneyworld, but by launching a Twitter account. So with the “Great American Race” as our inspiration, we start our engines on this week’s News in Review.

Sitting in the pole position is an article that raises the question of whether strong anti-corruption policies are actually having an impact on behavior. A recent Ernst & Young survey of employees at Asia-Pacific companies shows that nearly half of those employees believe that corruption is a real problem in their organizations, despite the presence of policies intended to prevent it. Nearly 25% of those surveyed say that the provision of gifts to win business is still commonplace. While 81% of the respondents say they would use an anonymous hotline to report concerns only 32% say their companies had created procedures to do so.

Businesses hoping to avoid the black flag for FCPA violations need to keep tabs on their third party intermediaries and resellers. The 2012 FCPA Resource Guide offered clarity on the question of whether companies are responsible for the actions of third parties. In addition, recent cases have reinforced the notion that the government holds companies responsible for the actions of third parties. One case from 2013 involved a company that used a freight forwarder to avoid paying customs duties and tariffs in Nigeria. In another, a company entered into a Non-Prosecution Agreement after the manager of a foreign subsidiary was found to have paid bribes to customs agents.

PhRMA is not happy with the Federal Trade Commission (FTC) over the transfer of patent rights and the organization is headed to court to do something about it. In November, the FTC made a change to the Hart-Scott-Rondino Act over premerger notification rules that applies only to the pharmaceutical industry. PhRMA filed suit to have the change declared unlawful, saying the costs of compliance with the rule will be significant.

On the settlement front, Ranbaxy and Teva have been assigned a couple of penalty laps for restricting competition. The two companies settled charges with the state of New York over an arrangement that would allow Teva to sell the generic form of Lipitor in the U.S. should Ranbaxy’s generic not be approved. Each company agreed to pay $150,000 as a part of the settlement.

The West Virginia House Judiciary Committee has approved a bill that would create a state version of the False Claims Act. The bill provides for whistleblower awards, and if passed, will give the state a larger percentage of federal settlements.

And so ends this week’s race through the world of the compliance news you need to know. Have a great week everyone and we’ll see you back here next week!

 

Week in Review, February 10, 2014

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A device maker settles kickback charges, the Serious Fraud Office looks to beef up the UK Bribery Act, and the FDA makes plans to release more guidance on social media.

The Super Bowl, National Signing Day and the Olympics all in one week; it was a sports fan’s trifecta! Hopefully your team won the game…signed that all important recruit…or took home the early gold! As the best of the best gather in Russia and you keep track of the medal count (Canada, Netherlands and Norway are tied for the early lead), we’ll keep tabs on the world of life sciences compliance. It’s time to light the torch on this week’s News in Review.

That big curling match is about to start in Sochi, and darn it, today is the day you left home without your smartphone. No worries. According to a new study, your healthcare provider  should have one you can borrow. The study finds that the vast majority of physicians are toting smartphones and about 70% have tablets. They’re putting the devices to use in their practice with the tablets being the tool of choice for content heavy tasks.

Device maker CareFusion recently spent some time in the penalty box. The company agreed to pay $40.1 million to settle charges it concealed kickbacks to a physician and marketed its surgical prep solution for off label uses.

Serious Fraud Office chief, David Green, wants to change the rules related to the Bribery Act. Green is proposing an amendment to the Act that would subject companies to fines and blacklisting if those companies fail to prevent financial crime by their employees. The law currently has a provision whereby companies are held liable for failing to prevent bribery. Green says the new power would only be used in “exceptional cases.”

Fortunately, we can look forward to more commentary on research and drug marketing during 2014. The FDA is expected to release more guidance on the use of social media in drug marketing, and guidance on the electronic submission of promotional labeling and advertising. The OIG plans to investigate issues around the price of drugs, including whether off-label uses should be reimbursable. For more in depth expert analysis of the OIG Work Plan, check out the video released by OIG, during which representatives discuss the agencies top priorities for the year and emerging trends in combating healthcare waste.

Speaking of the FDA, the agency may be ready to step up its enforcement of the regulations prohibiting off-label promotion. At a recent conference, an attorney for Pfizer, Emily Wright, noted that the industry should expect to see an increase in enforcement in the near future. Wright made note that the FDA issued two letters related to press releases in 2012 and she expects to see more.

And finally entering the stadium (cue the triumphant fanfare)…Open Payments registration! CMS has announced that beginning February 18th, registration and data submission will commence in two phases. During the first phase (February 18th – March 31st), users can register in CMS’ Enterprise Portal, and submit corporate profile information and 2013 aggregate data. Phase two will kick off in May.

Well that’s it for this edition of the News in Review. As you marvel at the accomplishments of the world’s greatest athletes this week, don’t forget to take the time to analyze your compliance curriculum for areas that need enhanced training. PharmaCertify™ off-the-shelf modules and mobile apps offer up-to-date content on topics like, on-label promotion, good promotional practices and the Sunshine Act, where your staff needs it most–in the field and at their fingertips.

Have a gold medal week everyone!

Week in Review, February 4, 2014

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Industry teams with HCPs to formulate a framework for ethical collaboration, medical device companies are advised to keep their compliance programs robust, and pharmaceutical companies disagree on the Sunshine Act as it relates to support for medical writing.

How about that Super Bowl Sunday! No doubt there were cheers, laughs and maybe even a few tears shed as you and your friends gathered to watch the best of the best compete. Of course, we’re talking about this year’s Super Bowl commercials! And, yes, there was a football game played (sort of) in between those delightful bits of entertainment. The array of commercials included some that were memorable and humorous (that bizarrely fun Audi “Doberhuahua” spot) and many that we found downright confusing (Axe “Kiss for Peace?”). While it might not be as memorable as that Radio Shack spot, we like to think that this week’s News in Review is a production worthy of your time and attention.

Huddle up! A group representing the pharmaceutical industry, healthcare providers and patient advocacy organizations recently published a framework for ethical collaboration. The framework is designed to foster collaborations that further patient care, and it is supported by four ethical principles: put patient’s first; support ethical research; ensure independence and ethical conduct; and promote transparency and accountability. The group says regular information sharing and communication between patients, practitioners and the industry is vital to improving health and advancing medical knowledge.

Biotech and small medical device companies need to be sure they stay aggressive on offense when addressing FCPA compliance. Since biotech and medical device products often require additional approvals that increase the level of interaction with government officials, the risk of FCPA violations also increase. With life sciences companies in the cross-hairs of enforcement agencies, companies need to make sure their compliance programs are robust and comprehensive.

Share clinical trial results you will. Janssen announced it will share some of its clinical trial data through the Yale School of Medicine’s Open Data Access Project (otherwise known as YODA). YODA will serve as the vetting agent for clinical trial data requests from researchers and physicians. Some requests for the data will still be handled by Janssen R&D directly.

A federal judge is allowing a whistleblower case against Abbott to continue. A former sales rep filed the suit, alleging the company paid kickbacks and promoted its drug TriCor for off-label uses. Abbott moved to dismiss the case because the whistleblower failed to provide specific evidence of a false claim being submitted. The judge rejected those allegations.

Pharma companies are not reading the signals from the Sunshine Act the same when it comes to medical writing support. During the International Society for Medical Publication Professionals’ European meeting, representatives from several pharmaceutical companies revealed how their companies were handling medical writing support provided to authors of clinical studies, and not all companies agreed that there was any real transfer of value to physicians. AstraZeneca and Pfizer representatives said there was value to the author. Shire, on the other hand, saw the only value was to the company, and there was no need to report medical writing support. The Shire representative said they were collecting the information in case it ultimately has to be reported, but that the company was confident in its approach.

And with that, the clock has run out on this week’s News in Review. If you attended last week’s Pharmaceutical Compliance Congress, you heard industry peers and government regulators emphasize the need for an up-to-date compliance program that extends training beyond the check-the-box approach. The PharmaCertify™ suite of off-the-shelf compliance solutions offers the eLearning modules and mobile apps you need to extend critical compliance policies to where your team needs it most – in the field and at their fingertips.

Have a great week everyone!