Move Beyond the Basics to Make Compliance Training Stick

We’ve come a long way in life sciences compliance training in a relatively short time. Fifteen years ago, the common approach to compliance training often involved lawyers from the legal department, using PowerPoint slide decks to train large groups, once a year at POA sessions. Somewhere along the way, the industry recognized the importance of instructional design, and the power of technology, as the focus shifted to eLearning and the on-going search for ways to use it in an engaging and creative manner. That pursuit continues.

Instructionally-sound, creatively-scripted eLearning still represents an effective method for training large groups across a company, but to truly reduce risk, micro-learning concepts need to be strategically integrated to your curriculum. More targeted training, focused on specific subjects, and smaller audiences, is key. Let’s use anticorruption training as an example.

Anti-bribery legislation is on the rise around the world, and the increasing risks associated with the growing number of laws requires a comprehensive approach to your anti-bribery/anticorruption (ABAC) training. Core ABAC training, by nature, needs to address an expansive topic list, and it needs to be targeted to audiences as diverse as sales and marketing; medical affairs; regulatory; logistics; and manufacturing. Once that core training is launched though, the audiences that represent the highest risk (i.e., sales and marketing), and the topics that present the greatest risks to those audiences, (e.g., third-party red flags) need to be identified. As one example, deploying a smaller module on “recognizing and reducing third-party red flags,” to the sales and marketing audience after the broader ABAC module is completed, reduces risk for the one audience that has direct contact with third-party intermediaries.

Micro-learning doesn’t have to end with mini-modules. Employees are seeking information and training differently than they did back in those PowerPoint-driven years. Tools such as infographics and scenario-based video sequences offer more opportunity to make the focused learning stick, especially when spaced appropriately across a learner’s timeline and blended with other learning components. In addition, reinforcement doesn’t end with training. Apps offer an ideal method for delivering “just-in-time” reference content where the employees need it most – in the field and at their fingertips. In this case, offering access to a list of red flags, and tips for how to identify them, would drive down the risk for that sales and marketing audience.

The PharmaCertify team will be exhibiting at the 14th Annual Pharmaceutical Compliance Congress in Washington April 26-28. If you’re attending, stop by Booth 10 (it’s back there where CBI keeps all the good food!) to share your ideas for reinforcing compliance learning in your organization. After all, we’re compliance learning geeks – we want to hear them! And don’t miss Dan O’Connor, Senior Vice President for PharmaCertify™ at NXLevel Solutions, as he and his co-presenters offer a conference prelude session on healthcare compliance and policy applications.

See you in Washington!

Sean Murphy, Product and Marketing Manager

Compliance News in Review, November 18, 2016

Bring on the turkey, cranberries and uncomfortable family interactions! Thanksgiving is almost here. Soon enough, the stress of all that preparation will melt away as we share meals with friends and family, and depending on how you look at it, a day of crazed shopping the day after will either offer a little more relief or send the stress level right back to record levels. Before your planning kicks into full gear, we offer this small helping of all the compliance news fit to blog, in this edition of the Compliance News in Review. Get it while it’s hot!

The FDA and industry representatives gathered around the table for a two-day public hearing regarding off-label marketing. The agency’s long held opinion remains the same – sharing information about a use that has not been proven safe and effective presents a risk to public health. Industry representatives argued that in a changing healthcare environment, where prescribing decisions are not made exclusively by physicians, the FDA needs to end regulatory barriers and issue clear regulations permitting the sharing of truthful, non-misleading information. The FDA also expressed concerns about the effect that sharing off-label information would have on the industry’s incentive to conduct well-controlled, randomized studies, and that physicians may not have the time to discern what information is misleading.

Former Valeant executives and employees of the specialty pharmacy, Philidor, are being charged with engaging in a kickback scheme to the tune of millions of dollars. According to the FBI, a Valeant executive received $10 million from Philidor. The payments were allegedly laundered through a series of shell companies to avoid detection. In response, Valeant noted that the company itself had not been charged, and documents related to the case made it clear the two former executives attempted to defraud the company.

Teva is setting aside a substantial amount of “leftovers” in the form of $520 million to settle bribery allegations from the DOJ and SEC. The allegations are related to activities in Russia, Mexico and the Ukraine. The company said the allegations did not involve its U.S. business, and implied the issues stemmed from third-parties subsidiaries. Teva also announced that its governance program and processes have since been revamped and it has severed ties with the problematic third-party agents.

Pass the lawsuit, please. A Pennsylvania judge has denied GSK’s motion to dismiss a lawsuit brought by 41 insurers over medications manufactured at a now closed GSK facility in Puerto Rico. The medications were allegedly defective, and the insurers claim GSK induced them to purchase the drugs, and then failed to react when the defective drugs were discovered.

Pharmaceutical sales representatives will now need an invitation from the city to work in Chicago. City Council has passed an ordinance requiring all representatives to obtain a license as part of an effort to help stave off improper opioid prescribing. Reps will have to undergo training on ethics, marketing regulations, and other laws. The fee will be $750, and the license must be renewed annually. The ordinance will go into effect in July 2017. Revenue will be used to educate physicians and patients about opioids.

With that, we close this edition of the Compliance News in Review. Thanks for reading and we wish you and your family a happy and healthy Thanksgiving holiday!

Week in Review, February 4, 2014

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!

Week in Review, November 4, 2013

Week in Review, November 4, 2013
The FDA explores the Bad Ad program, targeting misleading drug ads for younger audiences; whistleblower cases shed light on Cephalon kickbacks and the government steps up corruption investigations.

It’s the most wonderful time of the year! When we’re nestled all snug in our beds with visions of sugarplums (or dew drops) dancing in our heads. Finally, Daylight Savings Time came to end over the weekend! Oh, the joy of receiving that precious hour back. We hope you made the most of that “free” hour over the weekend. We sure did! The back of eyelids never looked so good. It’s back to the grind now, so let’s get rolling with this week’s News Week in Review.

The FDA has decided it’s about time to study how teens perceive direct drug advertising. The study will gauge how teens respond to ads for fictitious acne and ADHD drugs. Studies have shown that the part of the brain that helps in discerning risk in decision making is not fully developed until the mid-twenties. The FDA wants to understand how teenagers judge the risk and benefits associated with the drugs in the ads to determine if changes should be made in the way certain drugs are advertised online.

The FDA has sprung forward with a new CME program as a part of the Bad Ad program. The agency will launch a web-based CME program to teach HCPs how to identify misleading drug ads. The course will focus on various types of advertising, and is open to anyone, even though it’s directed to HCPs.

The government will fall back from a pair of whistleblower cases against Cephalon. The first whistleblower case focuses on the off-label promotion of four drugs Cephalon co-promoted with Takeda. This is the second case brought by this group of whistleblowers against the company. The first case resulted in a settlement. In the second, the relator alleges Cephalon promoted three drugs for off-label purposes and paid kickbacks to doctors. The relator also alleges Cephalon and WebMD conspired to locate certain patient populations and promote drugs for off-label use to those patients.

A study by Taxpayers Against Fraud found that for every dollar the federal government spends on investigating and prosecuting healthcare fraud, it recovers $16. The study showed that between 2008 and 2012 civil, criminal and state recoveries were just over $18 billion. The study also showed that since 1987, recoveries totaled nearly $40 billion. China, the U.K. and U.S. are not dilly-dallying when it comes to corruption investigations. Speakers at a conference in Beijing said the countries are stepping up corruption investigations in the food and drug industry. This year, the U.S. government initiated 11 FCPA investigations of drug and medical device companies. According to a former DOJ official speaking at the conference, the agency believes there is considerable corruption occurring in drug firms overseas, and addressing it is a priority with the DOJ. John Tan, counsel with international law firm Reed Smith, said the Serious Fraud Office has six Bribery Act investigations under consideration.

Don’t overlook the importance of having administrative assistants spend time on anti-corruption training. Addressing the question of who should be included in FCPA training, the FCPA Professor points out that while administrative assistants may not interact with “foreign officials” directly, they can be a valuable asset in identifying FCPA risks if they receive training. The article references a recent article in the WSJ about the influence and power admins hold, and points out this should not be overlooked when determining your FCPA training audience.

Well, the clock has run out on another issue of the Week in Review. If all of this news surrounding product promotion has you wondering if your field force is up-to-date on the latest compliance practices, Good Promotional Practices from the PharmaCertify™ suite of customizable off-the-shelf eLearning modules, covers topics ranging from gifts and meals to speaker programs and the handling of off-label inquiries.

Have a great week everyone!

Week in Review, October 21, 2013

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.

Week in Review, October 7, 2013

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!

News Week in Review, September 23, 2013

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!