Open Payments

Compliance News in Review, August 25, 2016

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Here’s the tune we’re whistling this week: a California state senator pulls his own proposed transparency bill; an analysis of the FDA user fee programs yields interesting information; former Insys employees in court; FCPA woes at Orthofix International; and a new way for New Jersey residents to learn how much their docs received from the industry.

Summer is coming to a close all too quickly, but you still have a few weeks to cruise the boulevard, roll down the windows and belt out that favorite song at the top of your lungs. Sadly, these anthems tend to disappear at the first hint of cool temperatures, so dance on whilst you can! While you pump up the volume on your music delivery apparatus of choice, we’ll fire up a jam of own, with this edition of the Compliance News in Review.

It’s been a Cruel Summer for a California state legislator. The state senator who proposed a drug pricing transparency bill for the state has pulled the bill from consideration, saying amendments to the bill “made it more difficult for us to accomplish our fundamental goal.”

Could a recent analysis of FDA user fees stir up some Bad Blood? The analysis of FDA user fees showed that the FDA has collected over seven billion dollars in fees since 1992. These fees account for a large percentage, in some cases the majority, of funding for FDA review programs, and there is nearly $300 million dollars in unused user fees being carried by the FDA.

An interactive map shows the Blurred Lines between New Jersey physicians and the pharmaceutical industry. A state news website created an interactive map that provides details of physician and hospital payments from the pharmaceutical industry. Users search by zip code, and see payment details for hospitals and physicians in the area. The site also has an alphabetical listing of physicians and hospitals receiving payments. Data for the site was sourced from the Open Payments website.

Orthofix International allegedly got in the Danger Zone regarding improper payments made by its Brazilian subsidiary. In a recent regulatory filing, Orthofix International registered a charge of $4.6 million to settle potential FCPA charges. The company reported the potential violation to the DOJ and SEC in 2013, and has been cooperating with both agencies to resolve the matter.

If Life is a Highway, a pair of former Insys employees may be about to head down a bumpy road. A former district sales manager and former sales representative recently pleaded not guilty to charges they provided kickbacks to doctors in exchange for prescribing the company’s fentanyl drug. The two are accused of paying speaker fees to doctors for events that were held at upscale Manhattan restaurants and were social, rather than educational, in nature.

With that, it’s time for us to boogie on out of here. We hope to see you back on the dance floor for the next edition of the Compliance News in Review. Until then, stay cool, keep the summertime jams going, and stay compliant.

Compliance News in Review, August 19, 2016

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The Pfizer shareholder suit settlement, Open Payments Open Forum, Robert Callif addresses sharing truthful off-label information, a whistleblower suit, and it’s always Sunshiney in Germany in this edition of the Compliance News in Review.

Dum, dum, da, dum, dum, dum, dum. Dum dum da dum dum dum dum da dum dum dum dum. No doubt you recognized that familiar melody as “Bugler’s Dream” (a.k.a., the Olympic theme). The games in Rio are in full effect! If you’re like us, you’re suffering from sleep deprivation from all the hours of late night coverage. Fear not, we haven’t completely forgone compliance news in favor of sport. Take your mark, because we’re about to start this edition of the Compliance News in Review.

Pfizer is setting aside $486 million in “gold medals” to resolve the shareholder suit over concealing the safety risks of Bextra and Celebrex. The settlement is pending approval of the shareholders, and if approved, will end 11 years of litigation.

Open Payments is back on the track and poised for changes. In July, CMS posed several questions in the proposed 2017 Physician Fee schedule. The agency held an Open Door Forum for Open Payment stakeholders to provide responses to these questions. Much of the discussion focused on the reporting and reviewing of information related to teaching hospitals and whether to increase the number of payment categories. Other topics included pre-vetting data; the review and dispute process; and whether user accounts for physicians can be structured so they don’t expire after six months of inactivity.

A whistleblower claims Celgene isn’t playing the game fairly. A suit filed by a former company sales rep claims the company made donations in order to drive product sales. The suit claims the company made donations and then worked with the charities to assure that the majority of the funds were directed to patients who were using Celgene drugs. Celgene says the claims are baseless and the federal rules regarding donations were followed.

FDA chief Robert Califf spent time hurdling the issue of sharing of truthful off-label information at the recent BIO conference. In his remarks, Mr. Califf said scientifically supported information worth sharing should be on the product’s label, and that there is a responsibility to share use information gleaned through the clinical trial process and it’s reasonable to expect that information to be part of the product’s label. He noted that publicly available information that is not part of the label is trickier, and that the agency was “working on it.”

The score from the German judge is…575 million. According to the German news magazine Spiegel, payments made to German HCPs and HCOs totaled 575 million euro in 2015. The country made the data public in a searchable database following a suggestion by EFPIA. The magazine noted problems with the data being incomplete and inaccurate, and only 75% of pharmaceutical companies were represented. It called for the German government to consider legislation similar to the Sunshine Act in order to implement true transparency.

Well, we need to get back to the thousands of hours of streaming coverage – bring on the table tennis – so we’ll end this edition of the Compliance News in Review here. Enjoy the rest of the Games everyone, and stay compliant.

To Use Employees as Actors for Compliance Training or Not: That is the Question

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Shakespeare said, “All the world’s a stage,” but when that stage is your training video, should your colleagues be the players? Before taking the leap and giving employees their “fifteen minutes,” you need to weigh the advantages and disadvantages and determine how each approach could help or hurt the effectiveness of your compliance curriculum. At PharmaCertify™, we have differing opinions based on first-hand experiences developing compliance training and corporate video programs. Here’s where two of us landed.

The Case for Using Employees as Actors
Lauren Barnett, Compliance Content Specialist

One obvious reason to use employees in your compliance training is the cost. Actors, even non-union ones, are expensive. Depending on the level of the skill the actor brings to the table, the cost of talent can be one of the top expenses in your video. A video shoot can last anywhere from a few hours to a few days, depending on the requirements of your project, so using the “free labor” you have at your fingertips can have a significant impact on the overall cost of the project.

Businesses and industries often have their own jargon. Add the medical or product-specific lingo that may need to be included in the training, and understanding the script for your compliance video could be like learning a new language. Your colleagues will be more authentic when delivering jargon-laden lines on camera. Actors won’t have the contextual experience with the language to deliver lines naturally or with confidence. Your learners do have familiarity with the language and they’ll notice when the actors aren’t comfortable and the learning will suffer.

Finally, using employees from the compliance department, or other departments the learners only interact with on a remote level, humanizes those departments and has the potential to build a stronger rapport between compliance and the rest of the company. Too often, the compliance department is seen in a negative light, or as the “police,” who are just waiting for employees to do something wrong. A truly effective compliance training curriculum addresses that concern, and includes components designed to portray those responsible for policy and training as partners who are there to support, encourage and inform. Using team members as actors in the compliance training is one major step toward that goal.

The Case Against Using Employees as Actors
Sean Murphy, Product and Marketing Manager

You may see your coworkers as free talent, but they aren’t professional talent. Acting is an art and a skill, and the fact an employee “was in a play in high school,” doesn’t necessarily mean that colleague is a trained actor. Good actors, even those working in local theater, have typically trained for years in their craft. You might get lucky and have a gem or two in your free talent pool, but when you use someone who is not comfortable or experienced, you run the risk of the key messages being lost behind the bad acting.

You also have to consider the cost to the business in lost productivity when employees are spending their time trying to convincingly read lines. Video shoots are time-consuming (especially when multiple takes are required because the actors are not professionals) and often require the actors to be “on set” for a number of hours. When your colleagues are pulled away from their jobs for that extended period of time, others may have to do their work, or they will at least have to book extra hours to make up the work they missed.

Finally, yes, employees can add an air of authenticity to your video, but it comes with the risk of your learners focusing on the fact they are watching “Bill from Marketing” in a video. Your key training messages may be lost because the learner’s attention is focused on the fact that is “Bill from Marketing,” instead of the subject matter. Additionally, if the audience includes vendors, they won’t know Bill, so he’s just another actor for them, so any authenticity is lost, and if Bill isn’t a good actor, he’s now a distraction as well.

What’s Your Verdict?

Using colleagues as actors can add an element of authenticity and fun to your training videos and can certainly help with the budget department. Before moving ahead in casting colleagues, it is important to consider the training goals of the video and determine if using colleagues will serve those goals or will simply be a distraction.

Now, we want to know what you think. Have you tried using your coworkers as actors in your compliance training? Did it work well? What were the pitfalls? Do you agree with Lauren or Sean? Who gets the bragging rights this time? Contact Sean at smurphy@nxlevelsolutions.com to let us know.

Compliance News in Review, July 26, 2016

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Executives on trial, an FCA settlement, a “clarification” to a change in the District of Columbia detailer law, and an Open Payments open forum…all in this edition of the Compliance News in Review.

What do Teddy Roosevelt, Rob Lowe, and a chair have in common? They have all provided some rather famous, if not infamous, moments at the national conventions of the Democratic and Republican parties. Part pep rally, part three-ring circus, and part critical component in the fabric of this great democracy, the conventions are underway, and they have certainly provided entertaining television during the doldrums of summer. If your senses need a break from the constant barrage of politicking and speechmaking, let us gavel in all compliance news fit to blog, with this edition of the Compliance News in Review.

Guilty or not guilty? It was a little bit of both for two executives from Acclarent, who were on trial for selling misbranded and adulterated medical devices. The jury found the pair guilty of misdemeanor charges distributing misbranded and adulterated devices, but acquitted them of felony charges. Lawyers for both defendants said they felt confident that their clients would eventually be cleared on the misdemeanor counts.

Speaking of Acclarent, the company agreed to pay $18 million to settle allegations that it caused false claims to be submitted to government health programs. The government contended the Acclarent marketed one of its devices for a use that was rejected by the FDA.

The Washington D.C. Department of Health (DOH) released an FAQ sheet that was about as clear as most political speeches. The document is intended to provide guidance regarding a recent change to the D.C. detailer law. Unfortunately, it may have raised as many questions as it answered. The DOH recently made a change establishing that anyone engaged in detailing for less than 30 consecutive days did not have to obtain a license. Confusion seems to center on the Department’s definition of “consecutive.” The FAQ states that the exemption applies to those “individuals, such as speakers at a conference, who come to the District once a year, or other persons that come once a year for a short duration of time of less than 30 consecutive days.”” Makes sense right? But the FAQ also states the exemption is not meant to cover an individual who may come to the District for a few days, more than once during a calendar year. So how many visits to D.C. require registration as a licensed detailer? Stay tuned.

The Centers for Medicare and Medicaid Services (CMS) is conducting a “focus group,” of sorts. The agency is conducting a stakeholder forum on August 2 to solicit feedback on rulemaking and potential improvements to Open Payments. The forum is intended to give stakeholders an additional opportunity to comment on the recent questions posted by CMS about Open Payments in the proposed 2017 Physician Fee Schedule.

Well, that’s a wrap on this politically-charged edition of the Compliance News in Review. We now return you to your regularly scheduled convention coverage.

Stay compliant!

Compliance News in Review, July 14, 2016

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The Serious Fraud Office has its second application for a DPA approved, CMS solicits feedback, and experts are dismissed from an advisory panel due to perceived conflicts.

It’s hot, it’s humid, and the editorial staff at the New Jersey AND Georgia offices of the Compliance News in Review is already desperately seeking safety from the sun’s intense rays. The dog days of summer have arrived with gusto. If you’re looking for a good reason to spend a few more minutes in the comfortable confines of an air conditioned office or home, we suggest a deep dive into the cool waters of this edition of the CNIR, and all of the compliance news fit to blog.

Deferred Prosecution Agreements (DPAs) seem to be no sweat for the Serious Fraud Office (SFO). The agency has had its second application for a DPA approved in a case that involves violations of the UK Bribery Act. The company involved agreed to pay $8.48 million in fines and disgorgement. It must also report annually on its third-party intermediary transactions and compliance programs, and continue to cooperate with the SFO. The DPA remains in effect until 2020, but it may be terminated in 2018 if the company meets its financial obligations by then.

The Centers for Medicare and Medicaid Services (CMS) is basking in the Sunshine these days. In the proposed 2017 Physician Fee schedule, the agency solicited feedback for a number of questions related to the Open Payments program. The questions cover record retention, issues related to teaching hospitals, and the nature of payment categorization. Of particular note, the agency is seeking feedback about the benefits of pre-vetting payments with covered recipients and issues related to uploading data to Open Payments.

In an indication that their relationships with industry were a little too hot to handle, several experts have been removed from a panel that is responsible for advising the FDA about painkillers. The panel was created by the National Academies of Science, Engineering and Medicine, a larger advisory group to the FDA. The removal of the panel members appears to have been spurred by a letter Senator Ron Wyden sent to the Academy of Medicine complaining that some panelists had received support (in the form of grants) from pharmaceutical companies. One panelist, Dr. Mary Lynn McPherson, says the support in question did not go to her directly, it went to the university where she is on staff, and was in the form of unrestricted grants so the pharmaceutical companies never had input on how the money was used. Another of the dismissed panelists, Dr. Gregory Terman, says he was removed because the nonprofit group he heads received funding from several pharmaceutical companies. Terman says his association with the nonprofit was well known, and he has gone out of his way to avoid conflicts of interest.

The last story serves as a reminder that much of the data regarding the relationship between healthcare professionals and the industry is presented with little context as to the nature and reasons for the payments. HCPs are understandably sensitive about receiving certain transfers of value, and they have questions about how those TOVs are disclosed. Your transparency training should remind learners that they need to be sensitive about these concerns, and educate them on the proper protocol for addressing HCP questions about data.

With that, we close this mid-summer edition of the Compliance News in Review. Stay compliant and stay cool.

Compliance News in Review, July 5, 2016

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Another organization calls for a ban on Direct to Consumer advertising, two former industry sales reps are arrested for kickbacks, a former executive is acquitted on kickback charges, and CMS releases update TOV data.

Strike up the band and light up the fireworks! The American Experiment marked its 240th year this weekend. So, it’s fitting that the hottest ticket on Broadway these days is the story of one our nation’s founders. Since most of us won’t be lucky enough (or rich enough) to score tickets to Hamilton in celebration , we had to stick with the old standbys of parades, barbecues, fireworks. To cap the holiday weekend, we offer a new tradition to add to the list, the Independence Day edition of the Compliance News in Review.

The fireworks continue regarding DTC advertising. The American Society of Health-System Pharmacists is the latest group to express a desire to see DTC advertising of prescription drugs banned. In the past, the organization has been supportive of the advertising, as long as it meets certain criteria. Since it now believes the industry is ignoring the criteria, the group has withdrawn its support. A spokesperson says a complete ban is not possible, but he hopes this action will lead to a discussion between industry and healthcare providers about DTC ads. The current model of DTC advertising is outdated according to the spokesperson, and pharmacists and providers are spending too much time explaining to patients why drugs they see in ads are not appropriate for them.

A pair of former Insys sales representatives could be losing their independence in the near future. The two were arrested for allegedly paying over $250,000 in kickbacks to doctors who wrote prescriptions for the painkiller fentanyl. The complaint alleges that most of the money was paid for serving as speakers at programs that were essentially social functions. Very little, if any, educational information was shared, according to the complaint, and following the programs, the sales reps would often take the doctors out for drinks and other entertainment. In a statement, the company says the sales reps were no longer employed and company policy prohibits the giving of cash or other items of value as inducements for writing prescriptions.

It was no tea party in Boston for the feds in a case against a former Warner-Chilcott executive. W. Carl Reichel was acquitted of charges that he paid kickbacks to doctors. Prosecutors charged that the former executive created a strategy of paying kickbacks to doctors in the form of sham speaking fees, money, and free meals in exchange for writing prescriptions of Warner-Chilcott drugs. US Attorney Carmen Ortiz said the charges against Mr. Reichel were warranted, and while cases against executives are difficult to prove, they’re necessary to deter improper conduct.

CMS sent out its annual declaration about Open Payments data. The payment and transfer of value data has been published, and is now publicly accessible. This year’s data represents nearly 12 million records covering $7.52 billion paid to physicians and teaching hospitals. As usual, research payments account for the largest share of the total amount.

This edition of the News in Review reminds us that the consequences of non-compliant behavior can be quite personal. When the big headlines tend to be about the multi-million and multi-billion dollar settlements paid to settle charges of fraud and non-compliance, convincing individuals that there is also a price to pay can be challenging. Citing cases like these in your training is one way to inform commercial staff and executives of those consequences.

While we don’t advocate turning compliance training into something akin to “Scared Straight,” sharing the full landscape of government enforcement actions is important. This is especially true following last year’s memo from Deputy Attorney General Sally Yates about the DOJ’s emphasis on holding individuals accountable in cases of corporate wrongdoing.

That’s it for this edition of the Compliance News in Review. Stay compliant!

News in Review, June 15, 2016

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Federal investigators subpoena information related to charitable organizations from three companies, Congress proposes an amendment to the FDCA, the head of the FDA speaks on off-label information, and New Hampshire’s Attorney General targets the manufacturer of a popular painkiller.

The temperatures are rising well past 70 degrees Fahrenheit and that can only mean one thing…time to hit the beach! Pack up the station wagon, minivan, or whatever mode of transportation best accommodates your gear and head to the sand and surf for some fun and relief from the heat! Of course, the standard precautions and warnings are in order: use plenty of sunscreen; mind the flags regarding ocean conditions; and above all, be wary of teens resembling Frankie Avalon and Annette Funicello bursting into fits of random dancing and singing (now there’s a dated reference for you). Of course, you’ll need plenty of reading material before you drift off into a coconut oil scented daydream. So after you finish the latest from Mary Higgins Clarke or that true crime tome, please enjoy the next best beach read…this edition of the Compliance New in Review.

The waves of compliance just got slightly chopping for a trio of drug manufacturers. Three companies, Gilead, Jazz and Biogen, received subpoenas from federal investigators for information related to their relationships with charitable organizations that help patients with medication costs. Charities receiving support from industry companies claim those companies have no say or influence on which patients they help or what drugs are covered. The government’s concern centers on whether the contributions are essentially illegal kickbacks.

Oh sunny day – a panel of the House of Representatives Energy and Commerce Committee proposed an amendment to the Food, Drug and Cosmetics Act that would allow companies more leeway in sharing truthful off-label information. The proposed amendment would limit the definition of intended use to the manufacturer’s “objective intent,” and allow for the dissemination of materials for scientific exchange, if the information in the materials is backed by scientific evidence. The panel expressed concern about the need for doctors to be kept abreast of the latest medical information, and frustration at the lack of movement by the FDA on guidance related to the dissemination of off-label information.

The head of the FDA also rode the off-label promotion wave when he spoke at the BIO International Convention. In his remarks, Robert Califf noted that supportable information worth sharing should be included on the product’s label, and he questioned why companies would not include useful information on the label or in the prescribing information. Califf also encouraged the industry to embrace social media, saying, “the best way to develop products in the future is likely going to involve a lot of people with diseases to have a handle on what their needs are, what their expectations are, and what their risk tolerance may be.”

As expected, Vermont was first in the water with a law requiring transparency of drug pricing. State officials will identify 15 drugs for which they want information about the reasons for price increases. The manufacturers of those drugs will have to submit information to justify the price increases.

New Hampshire Attorney General’s office has filed suit against Purdue over the company’s refusal to provide documents related to the marketing of OxyContin. The AG’s office claims the company is providing HCPs with misleading information regarding the product. The suit claims the company touts the drug lasts for 12 hours, and it also does not appropriately address end-of-dose failure. The AG also claims the company downplays the risks associated with addiction. Purdue says it is more than willing to cooperate with the investigation, provided the AG’s office does not share any documentation with private attorneys. The company believes a financial conflict of interest exists with the firm retained to assist in the investigation, and it should not be compelled to turn over information while a court case is pending.

A report from Reuters questions the independence of firms hired by companies under a CIA to serve as an Independent Review Organization (IRO). Unlike other agencies, the Department of Health and Human Services does not prohibit companies under a CIA from hiring an IRO with which they have an existing relationship. Critics claim those arrangements represent a conflict of interest. A representative of the HHS Office of Inspector General (OIG) said she has not witnessed any issues with these arrangements. Spokespersons for various industry companies said they disclose all their business relationships to the OIG in advance.

The seas have also been choppy for Salix Pharmaceuticals recently. The company agreed to pay $54 million to settle allegations it provided kickbacks to physicians for prescribing its products. According to the DOJ, the company admitted to paying doctors to be speakers for the company as an inducement for prescribing its products. The government claims the programs at which the doctors spoke were largely social in nature and provided little or no information related to a product. In addition to resolving the federal case, the settlement will resolve several related state fraud cases.

That’s all for this edition of the News in Review. Until next time, we wish you safe sailing and calm compliance waters!

Compliance News in Review – In Case You Missed It, April 2016

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Wow, we’re already a week into May 2016. Time flies when you’re staying compliant. If policy writing, auditing, monitoring, or compliance training development kept you too busy to keep up with all of the April compliance news, not to worry, we have a summary of all the compliance news that was fit to blog throughout the month…with the ICYMI, April 2016 edition of the Compliance News in Review.

A new study suggests drug ads aren’t particularly effective in prompting patients to discuss the advertised drug with their doctor. In fact, only 7% of people were moved to discuss a drug with their physician after seeing a televised ad. While they may not be motivated to speak to their physician, viewers do notice the ads. The survey found that 64% of the respondents said they believed they saw more drug ads over the past year.

Shionogi received a warning letter for omitting risk information on a co-pay coupon for a drug that treats lice. The FDA said the coupon touted the efficacy of the product without stating any of the risks.

The Department of Justice announced a pilot program for companies to self-report violations of the FCPA in exchange for reduced penalties. Under the program, companies that self-report and take steps to remediate identified problems will be eligible for the reduction in penalties.

Pfizer and the DOJ announced the settlement of the case involving Pfizer’s Wyeth unit. The company agreed to pay $784.4 million to resolve charges it had reported false and fraudulent price information to the government.

Ten of Canada’s top drug firms plan to voluntarily disclose aggregate physician and healthcare organization payment data. The movement was started by GSK Canada, and multinational firms like Abbvie, Purdue, BMS, and Lilly soon joined.

CMS held a webinar for Open Payments stakeholders. The agency’s remarks focused on program timelines, in particular, the review and dispute period. A question and answer session for participants was included.

The Massachusetts Medical Society is now requiring its members to disclose financial ties to industry when posting information or reviewing a medical procedure or service on the Internet.

With the review and dispute period for Open Payments in full swing, it is good time to make sure those in customer facing roles are up to date on the requirements of the Sunshine Act, and your company’s procedures for addressing questions from covered recipients. Sunshine Act and Open Payments, from the PharmaCertify Foundations™ curriculum of eLearning modules, provides an overview of data collection and reporting responsibilities, and is easily modified to include your company-specific policy on how to handle questions from covered recipients.

Stay compliant and here’s to a merry month of May!

News and Notes from the 13th Annual Pharmaceutical Compliance Congress

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CBI’s 13th Annual Pharmaceutical Compliance Congress, held last week at the Ritz-Carlton in Washington DC, offered an impressive lineup of industry luminaries and government regulators discussing a wide range of compliance-related topics. While some of the discussions didn’t offer much in the way of groundbreaking information (tone at the top, embed compliance in the businesses, relationships matter, etc.), the concepts presented were critical for any attendees new to their role or the world of life sciences compliance in general.

Embed Compliance into Business Practices

There was the expected emphasis on the concepts of embedding compliance into business practices and gaining buy-in from the C-suite. One panelist even mentioned that when asked to join her current company, she insisted that she be a member of the North American leadership team and therefore have direct access to the business leaders. As another speaker put it, “relationships matter, and you have to speak the language of the businesses in their terms.”

Tie Compliance to Incentives

One compliance officer from a small pharmaceutical company referenced the need to make sure sales incentive is tied to compliance, to make the concepts and policies more meaningful – a concept that was considered revolutionary in the industry just a few years ago. She added that sales management needs to own the compliance metrics in order for there to be lasting and real change. The same global officer touched on the challenges of doing business globally and the need to have tough conversations about spending caps. “You will get pushback,” she stressed, “but don’t compromise. There’s no need to take that kind of risk.”

Transparency: Think Globally, Act Locally

Continuing on the global front, presenters reviewed the merits and details of global transparency codes like EFPIA, while touching on upcoming movements toward laws and guidance. When dealing with global regulations and codes, the potential for confusion reigns. For example, when providing meals to HCPs from various countries, one panelist advised audience members to use the lowest common denominator for the meal limit, BUT, don’t forget to take Loi Bertrand into consideration if an HCP happens to be from France.

In addition, panelists stressed that companies can’t fall into the trap of thinking that because they are familiar with the rules around the Sunshine Act and Open Payments, they can roll right into global reporting. As one speaker from a large pharmaceutical company suggested, you have to look at it differently. “If you approach it like you approach Open Payments, your credibility will be challenged.”

Yates Memo and Individual Culpability

Among the regulators and defense attorneys who spoke during the conference, one common theme was the Yates Memo, and the affect it has (or is some cases, doesn’t have) on how investigations are conducted and cases prosecuted. The Memo, which is named for Department of Justice Deputy Sally Quillian Yates, was released in September of 2015. It generally states that the DOJ will increasingly target individuals in corporate crimes. A number of the regulators stressed that while the Memo is significant in its scope, it will not necessarily change how their offices pursue pharmaceutical and medical device cases. During the U.S. Healthcare Fraud Enforcement Panel, one US Attorney said it “codifies what they have already been doing in her office” and another commented that he asks his prosecutors to always look at individual culpability in each case.

Innovations in Training

As a compliance-focused learning company, we at PharmaCertify™ pay close attention to presentations and commentary with a slant toward training. It’s been a slow process, but based on the information and concepts presented in this and other recent conferences, it’s clear to us that companies are integrating exciting and novel techniques into their curriculums. Innovative compliance departments are adding micro-learning solutions and app-based tools in an effort to raise the level of engagement among their learners, which is music to our ears.

One company representative detailed the planning process and upfront analysis she and her colleagues conduct to ensure that training concepts meet the needs of the business as well as the compliance department. Once those needs are identified, they look for unique ways, including a healthy dose of humor, to make their messages stick. She and her co-presenter reviewed the details of the compliance app recently launched across the company, which uses self-produced video sequences, with compliance department employees as actors, to communicate the concepts. While we agree that technique can help to “humanize” compliance, as we warned in a recent post, you need to be careful that bad acting doesn’t distract from the important messages.

While this year’s Pharmaceutical Compliance Congress featured much of the same themes as recent conferences, the ever-evolving world of life sciences compliance always offers new twists and turns for those tasked with ensuring their individual companies remain in alignment with the latest rules and regulations. These conferences offer attendees the invaluable opportunity to learn best practices, tips, and updates directly from their peers and government regulators from around the world. They shouldn’t be missed.

See you at the next conference!

Compliance Edutrainment: Too Much of a Good Thing?

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These days, the standard airline safety presentation is delivered via video on most aircraft. Somewhere along the way, airlines decided this approach was an opportunity to express their creative spirit, and a bit of a competition developed, with the imagined spoils going to the company that produces the most entertaining safety video. That competition reached a new level when Virgin America rolled out its Safety Dance video. It boasts talented singers and dancers (and one Olympian) delivering the FAA- required safety information. If the objective is simply to entertain, then mission accomplished. However, if the objective is to educate passengers about safety protocol, we’re not sure it hits the mark.

The world of compliance training has thankfully evolved beyond the “death by PowerPoint” approach that dominated the life sciences landscape years ago. Those charged with developing compliance training now look to create programs that are more engaging and entertaining. In the case of eLearning, a number of tools and techniques can be applied to deepen engagement and learning, but if overused, or misused, the same tools have the opposite effect and distract from the learning. We call this the Edutrainment Trap.

All good adult learning starts with objectives, answering the question, “What do I want the learner to know and be able to do by the end of this training?” Enamored with the latest tools and ideas, losing sight of objectives once we start to design and develop the learning is easy. Here are five tips to help keep your compliance organization from falling into the Edutrainment Trap:

  1. Use Interactivity Intelligently: The interactivity itself is often overused in online compliance training. Of course, a well thought-out level of interactivity is important, but overloading the interaction on every screen only serves to distract the learner from the salient points. When covering critical topics like off-label marketing and privacy, interactive exercises and games need to be integrated intelligently, and in a manner that doesn’t cloud the learning with unnecessary messages. Interactive elements should serve a purpose, and not just be included for the sake of entertainment.
  2. Include Targeted Imagery: Images and graphics are sometimes misused or overused in a way that distracts from the core objectives. There is truth to the phrase, “a picture is worth a thousand words” and well-placed imagery is certainly more engaging than an overabundance of text on screen. But when the objective is to ensure the learner can “demonstrate an understanding of the payments that need to be reported under the Sunshine Act,” pretty pictures only go so far. Relevant images and graphics that reinforce key concepts and support learning objectives are needed.
  3. Mind the Bandwidth: Video and animation offer exciting opportunities for compliance training, but like any new tools, they need to be utilized judiciously and with the objectives in mind. In this time of high-speed corporate networks, we can forget that bandwidth is sometimes an issue for third-party vendors. An overabundance of video or complex animations may cause problems. Think carefully about geography and access when developing that global transparency module for deployment around the world.
  4. Remember that Acting Counts: If live actors are being used, make sure the subject matter remains the star of the training. Oscar-quality acting isn’t necessary for the training to be effective, but there is a fine line between amusing amateur acting and just plain bad acting. When the goal is to communicate the seriousness of a topic like the Anti-kickback Statute and its implications, amateur acting will derail any hope for effectiveness, as the learners start to pay more attention to the acting, and not the learning. Similarly, the more conversational the dialogue, the better. If the narration sounds like someone is reading a law journal or compliance policy, learners will tune out.
  5. Be Mindful of Cultural Differences: Making cultural references or using humor can be a fun way to interject life into training, but it has to be included carefully. Jokes can lessen the importance of the message. Cultural references that the audience may not understand can frustrate and ultimately distract the learner, leaving them saying “huh?” instead of “I got it.” This safety video by Delta is a great example. The video is entertaining, funny, and clearly communicates the required safety information – all good things. However, if the learners are not familiar with the nature of viral videos and Internet stars, the humor is lost, and the random assortment of characters only leads to confusion.

Avoid the Edutrainment Trap of loading training with every bell and whistle imaginable in the effort to make the learning fun and engaging. A good balance of imagery, text, and interactivity keeps training interesting and flowing and is a necessity in today’s complex regulatory landscape. Understanding which techniques are most effective and appropriate for the learners and the subject matter is the key to developing effective and highly-engaging training.

Thanks for reading and stay compliant!