Discount Registration: Pharmaceutical and Medical Compliance Congress

The 17th Annual Pharmaceutical and Medical Device Compliance Congress is scheduled for October 19-21 and the PharmaCertify team is looking forward to catching up with colleagues and sharing demos of our newest compliance training solutions. As a conference sponsor, we have the opportunity to offer you a $600 discount on the full conference registration cost. If you’re interested in taking advantage of this opportunity to hear industry professionals and government regulators discuss the latest guidance and share best practices, contact Dan O’Connor at doconnor@nxlevelsolutions.com.

If you can’t make it this time, don’t worry, we’ll be posting updates on the PharmaCertify Twitter feed, and a conference review on the our blog soon after the conference closes.

Thanks for reading and stay compliant!

 

Compliance News in Review, September 15, 2016

Illinois tackles illegal drug promotion by Insys; the ABPI calls out two member companies for breaking promotion rules; the Australian legislature shines a light on corporate crime and Medicines Australia reports on payments to doctors; and AstraZeneca settles with the SEC…all in this edition of the Compliance News in Review.

You had to know it wasn’t far away when “pumpkin spice everything” started appearing on store shelves. After the long hot summer, the staff here at the Compliance News in Review couldn’t be more excited that football is back, and cooler days with it (hopefully). Whether you’re a fan of college, or the league where they play for pay, the season is short, but that’s what makes it so special. Yes. football is now our focus, but not so much that we won’t continue to provide you with all the life sciences compliance news fit to blog. So, strike up the band, we’re ready to take the field on this edition of the Compliance News in Review.

The Illinois Attorney General is lining up against Insys. The state has filed suit against the company for illegal marketing of its fentanyl drug. The drug is approved for treating pain in cancer patients, but the AG alleges the company has been marketing the drug for treatment of other types of pain. The company also encouraged doctors to write prescriptions for higher, more expensive doses of its product, despite FDA recommendations to use the lowest dose of opioids possible, according to the suit.

The Association of the British Pharmaceutical Industry (ABPI) threw a flag on Hospira and Napp Pharmaceuticals. The organization has accused the companies of breaking the rules regarding promotion of biosimilars. An investigation found that Napp Pharmaceuticals made inappropriate payments to physicians attending a meeting that was deemed an advisory board. Hospira allegedly invited U.K. doctors to attend a meeting outside the U.K., which was a not a genuine advisory board, where their drug was promoted.

The Australian legislature will huddle about the state of its anticorruption law. After two Australian companies were implicated in a case involving the bribery of foreign officials, a member of the Australian senate decided to relaunch a committee to address corporate corruption. The mission of the committee is to improve Australia’s response to corporate crime and the senator noted that compared to bribery laws in the U.S. and U.K., Australia’s law is inadequate.

The “score” regarding industry payments to physicians in Australia has been posted for public review. Between October 2015 and April 2016 doctors received $8.5 million from industry according to a report from Medicines Australia. The organization says this report provides patients with more information than ever before about the relationship between doctors and the industry, and that the organization’s “standards for ethical and transparency will improve the Australian health care system.”

Thanks to an “ineligible receiver” call from the officials at the SEC, AstraZeneca has agreed to pay $5.5 million to resolve FCPA related charges. The SEC alleged that the company did not have proper internal controls in place related to interactions with foreign officials – mostly healthcare providers – in its China and Russian subsidiaries. The agency contends that improper payments, in the form of cash, travel, and gifts, were documented as bona fide business expenses. While AstraZeneca did not admit or deny any wrongdoing, it did cooperate fully with the investigation.

This week’s review had a decidedly foreign flavor. Where compliance outside the U.S. is concerned, we recall a quote from Pulp Fiction (bet you never thought a Tarantino film would ever be referenced in blog post about compliance) when Vincent Vega is discussing the differences between European countries and the U.S. “They have everything there we have here. It’s just a little bit different.” The same can be said for compliance issues. While the principles or requirements related to drug promotion may be the same here and abroad for the most part, there are small differences between what is permitted in the U.S. and what is permitted around the world. Life sciences companies must train employees about practices that are appropriate when conducting business outside the U.S., particularly in their interactions with non-U.S. HCPs.

With that, the time has expired on this edition of the Compliance News in Review. Don’t forget to click that blue button on the right to “follow” our blog so you’ll receive notifications when we post new content.

Until next time, stay compliant and enjoy the games!

Making the Most of Face-to-Face Time with Learners

by Lauren Barnett

Time in front of learners is a valuable commodity. Everyone throughout your organization is busy with his or her designated responsibilities, and the demands on a learner’s time makes scheduling training time challenging. If the learners are field-based,  the opportunities for face-to-face time are limited and everyone is scrambling for their share. So compliance trainers need to make the most of live training time in order for learners to walk away with an understanding of how the policies, rules and regulations affect their jobs day-in and day-out.

Effective and targeted compliance eLearning is one solution. Deploying eLearning before the live session gives trainers the ability to focus their live training time on the application of policies, and any changes in the working environment that might affect the exact interpretation of the rules.  It also allows the trainers more time to delve into learners’ questions about how to handle the situations they face.

Don’t Forget the WIIFM

When learners come to a live session with a baseline knowledge, trainers can utilize role-playing scenarios or interactive games to make the foundational knowledge presented in the eLearning more meaningful. This approach sharpens the WIIFM (What’s in It for Me) in the learner’s mind. When learners understand how the laws and regulations actually affect their daily activities, the information “sticks” even more and the potential for behavior change is stronger.

The Landscape Might Change 

While laws, regulations and policies may not change often, the environment in which learners operate is fluid. Using eLearning courses for foundational training, before the live session, allows trainers to spend that face-to-face time discussing any changes in the company business or the industry. For example, over time, an off-label use of a product may emerge, or a company may enter into a foreign market, creating new risks and/or laws that have to be addressed through training. By deploying eLearning to cover any new laws or policy basics, trainers can use their live time to discuss the more specific details of how those changes are played out in the field.

Leave Time for the Gray Areas

Inevitably, the application of compliance policies and regulations is sometimes left open to interpretation. The nature of those policies can leave those in the field mired in confusion and lost as to how to apply related policies. When you train the foundational knowledge through eLearning, face-to-face training time can be used as an opportunity to answer those questions and educate the learners about how to conduct themselves in a compliant manner. That type of feedback and dialogue represents a major step toward reducing risk and strengthening your compliance culture, as staff learn how to apply the principles, even when there isn’t a ready-made answer in the policy.

Make it Stick

Face-to-face time with learners is a valuable and precious commodity, and as a trainer, you need to seek methods for making that time as rewarding as possible. Deploying a baseline of eLearning courses, such as those found in the PharmaCertify Compliance Foundations™ curriculum, frees the trainer to spend that time detailing how the laws, regulations, and policies affect the learners’ daily activities. When learners understand compliance is not a set of draconian rules, but rather integral facets of what they do daily, the information is more likely to stick with learners and drive more ethical and compliant behavior.

Lauren Barnett is a Compliance Training Content Specialist for the PharmaCertify division of NXLevel Solutions. When she is not identifying subjects for the company’s Compliance Foundations suite of off-the-shelf eLearning modules, or working with clients to create custom training content, she can be found gleefully volunteering for her daughter’s high school band and theater programs.

Compliance News in Review, August 25, 2016

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

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

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

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!

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