fair balance

Compliance News in Review, March 27, 2017

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

Everything’s coming up roses, off-label speech, and corruption, in this edition of the News in Review.

We’ve got the fever…Spring fever! Spring has sprung, and we couldn’t be happier. Warmer weather, more daylight, budding trees and flowers, what’s not to love (besides the severe weather, commuting in the dark, and pollen)? This Spring, the flowers aren’t the only thing blooming, though. A new edition of the Compliance News in Review has appeared in our garden.

Arizona gets to claim the first “bloom” for sharing truthful off-label information with the governor signing the Free Speech in Medicine Act into law. The law protects the free speech rights of those in the medical community to discuss truthful off-label information about FDA approved drugs. It covers speech that is “not misleading, not contrary to fact, and consistent with generally accepted scientific principles,” and only deals with discussions between pharmaceutical companies and healthcare professionals. It does not cover off-label discussions or advertisements targeted to consumers.

The FDA has stemmed the implementation of a new off-label regulation. The agency announced in the Federal Register that it would delay the effective date of a final rule related to “intended use” regulations until March of 2018. It is delaying the effective date to consider public commentary. In February, industry trade groups petitioned the FDA to indefinitely stay and reconsider the rule.

Is a late season chill on the horizon for Novartis? According to a media report, the South Korean government is considering additional penalties against the company in relation to a kickback case. The government’s Ministry of Food and Drug Safety has already imposed a fine against the company and suspended the sale of some of the company’s products. A source at the Ministry of Health and Wellness said the government was considering lowering the price of the drugs involved in the kickback case. Novartis said the court case was on going, and it wasn’t aware of an “imminent” decision from the Health Ministry.

“New life” is being breathed into the FCPA Pilot Program. At the American Bar Association’s National Institute on White Collar Crime , Acting Assistant Attorney General, Kenneth Blanco said the DOJ will evaluate the Pilot Program and determine what, if any, changes should be made. Until the evaluation is complete, the Pilot Program will remain in force. The Pilot Program, the common name for the DOJ Fraud unit’s guidance on FCPA investigations and prosecutions, was due to expire on April 5. The Pilot Program is intended to encourage individuals and companies to voluntarily self-disclose instances of corruption, and establishes requirements for voluntary self-disclosure, cooperation with investigations, and the resolution of FCPA cases.

The growth in global anticorruption settlements and activity is sure to be a hot topic at the Pharmaceutical Compliance Congress, April 26-28 in Washington, DC. The PharmaCertify™ team will be providing demos our new Compliance Foundations™ module, Global Anticorruption Laws, along with all our new and updated compliance training products, at Booth 10 on the Exhibit Floor.

See you in Washington!

The Forgetting Curve and Compliance Training

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

 

What exactly does a 167-year-old German scientist have to do with your compliance training? As a chief compliance officer, or training manager, the answer may keep you up at night – especially if you haven’t integrated micro-learning elements continuously into your company’s compliance learning curriculum.

Hermann Ebbinghaus was a German psychologist who is credited with theorizing fundamentals of human learning, including the learning curve, the spacing effect, and the forgetting curve. The Ebbinghaus Forgetting Curve essentially states that what humans remember after a learning event drops steeply soon after completion of that event. His research shows that memory loss continues to increase until it finally flattens around 30-days post event.

 

Steven Just, Ed.D., Chief Learning Officer at Intela Learning, a developer of continuous learning platforms, writes, “What gets stored in our long-term memories is subject to decay (i.e. forgetting)… deep learning occurs when memories are stored in long-term memory and stabilized. This is called memory consolidation.”

Fortunately for those of us seeking to reduce compliance risks across a company, spacing follow up micro-learning components, in smaller chunks, across a learner’s timeline helps flatten that forgetting curve and increase retention. As Dr. Just writes, “Retrieve the memory from long-term memory, bring it into working memory, process it, and then re-store (re-encode) it in long-term memory.”

Micro-learning Tools

Short “sprints” of learning deployed in follow up to foundational compliance training provides that opportunity for the concepts to be “re-stored” in the learner’s long-term memory. Micro-learning can include brief mini modules focused on one topic that you’ve identified as needing reinforcement. If gifts and meals are a high risk for your HCP-facing employees, a scenario-based mini module built around a common situation they face in the field, deployed soon after the comprehensive training, is one method for alleviating their concerns and reinforcing the appropriate behaviors. Mini modules aren’t the only effective tools for flattening the curve though. Short learning nuggets like quizzes and gaming, strategically deployed over time serve to heighten retention as well. As another option, sprint activities and scenario-based mysteries can be delivered in a competitive workshop format to reinforce participants’ understanding of policies and principles. (We call it the Compliance Reality Challenge).

Code of Conduct

Considering the range of topics covered in a typical code of conduct, from workplace violence; to harassment; and gifts and hospitality, a more creative and engaging approach to reinforcing the initial code training is not only a good idea, it’s crucial to improving the learning. One approach we’ve deployed to successful reviews is what we’ve titled Know the Code. Working with the client, we target specific topics within the broader code of conduct to create a “streaming” series, with each 7-minute “episode” built around those topics. Each animated scene in a scenario lasts approximately one minute. A narrator character tells the story and when necessary, directs the learner to take part in on-screen activities, with individual character voices employed to bring life and realism to the scenarios. The episodes are strategically released across a timeframe designed to once again, “re-store the concepts originally covered in the core module into the learners’ long-term memories.”

Keep it Continuous

The bottom line: to make compliance training as effective as possible in terms of reducing risk across the company, the learning nuggets you continuously rollout after the initial event (eLearning module, instructor-led training, etc.) are as important as the initial event itself. PharmaCertify offers the reinforcement tools, instructional expertise and an exciting new system that uses the most widely-accepted algorithm for creating and delivering post-training learning sprints to accomplish that goal. If you’re attending the 14th Annual Pharmaceutical Compliance Congress April 26-28, stop by Booth 10 to see demos of the products and platform, and ask how we can help reduce risk and strengthen the compliance culture in your company.

Thanks for reading and we’ll see you in Washington!

Sean Murphy, Product and Marketing Manager, PharmaCertify™

Compliance News in “Preview”

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

As we wistfully wish 2016 a fond farewell, we welcome 2017 and wonder what compliance surprises, developments, and news the year might hold. What will be the hot topics debated around the water cooler in your office? The team at the Compliance News in Review has dusted off its crystal ball once again and we offer a few suggestions on what we see as the hot topics for 2017.

Drug Pricing Transparency

Drug pricing was at the top of the list in 2016. CEOs were brought before Congressional panels to explain exorbitant price hikes, and in several states, laws were proposed that will companies to disclose factors related to drug pricing for certain drugs. Vermont was the only state to pass such legislation, but California has reintroduced the bill for this session. The federal government also got in on the act with a bipartisan bill introduced in the Senate. While some of the fervor has quieted, we don’t think we’ve heard the last of pricing transparency. The passage of Vermont’s law could be the catalyst other states need to get their own laws passed.

Off-label Guidance/Revised Regulations

We don’t expect to see new guidance or regulations in 2017, but the FDA did at least start a conversation with the industry in 2016. A two-day meeting with stakeholders in November resulted in a list of diverse statements and opinions from companies, the medical community, and patient groups. The meeting with stakeholders was a step in the right direction, but a few high-profile cases (Caronia, Amarin, and Pacira) that resulted in wins for the industry, only led to more confusion and questions. We are cautiously optimistic that the FDA will at least continue the conversation and somewhat clarify the regulations.

Warning Letters and Notice of Violation Letters

The FDA’s Office of Prescription Drug Promotion (OPDP) wasn’t very active in 2016…until December, that is. At the end of the year, the agency made up for lost time by sending six letters for non-compliance with drug promotion regulations, signaling (in our humble opinion) a more aggressive approach in 2017. Most of the letters that were sent in December were related to the use of digital media.

Bribery and Corruption Enforcement

In 2016, several companies settled with the Department of Justice over Foreign Corrupt Practices Act (FCPA) violations. Most notable was a $500 million plus settlement with Teva that occurred near the end of the year. We expect to see more settlements this year, with half a dozen life sciences companies already under investigation for FCPA violations, according to the most recent Corporate Investigations List on the FCPA Blog. One wonders if the Serious Fraud Office (SFO) will join the trend as well and pursue more UK Bribery Act cases now that the agency has dipped its feet into the pool of U.S.-style Deferred Prosecution Agreements. We wouldn’t be surprised to see SFO dive right into the deep end.

The 2017 year in life sciences compliance looks to be an interesting one, and we’ll be tracking the news and headlines through our Compliance News in Review updates. Don’t forget to “follow” our blog so you don’t miss any news or our tips and best practices for building and deploying the compliance training you need to reduce risk and strengthen your compliance culture.

Thanks for reading and best wishes for a compliant and successful 2017!

Compliance News in Review: the 2016 Year-End Summary

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

Here we are again. Another 584 million-mile (940 million km for our metric friends) trip around the sun is nearly complete. It seems like just yesterday we were celebrating the beginning of 2016 and now we’re picking out our favorite brand of champagne to celebrate its end. Before we break out the noisemakers and party favors, let’s take one last nostalgic look back at some of the life sciences compliance-related developments of 2016.

A new milestone was reached regarding HCP spend disclosure. The first disclosure reports under the EFPIA Disclosure Code were released in 2016. Gaining disclosure authorization from individual HCPs proved to be a challenge for the industry and the numbers of doctors who granted authorization ranged widely between countries. According to Britain’s pharmaceutical trade association, ABPI, 70% of their HCPs granted authorization and in Ireland, just over half of HCPs did so. In other transparency developments, ten of Canada’s top drug firms announced plans to voluntarily disclose aggregate physician and healthcare organization payment data. The movement was started by GSK Canada, and other multinational firms including Abbvie, Purdue, BMS, and Lilly followed.

Drug pricing was a big story in 2016. Former CEOs from Turing and Valeant were called to testify before Congress about drug price hikes, and Mylan’s CEO was called to testify over dramatic increases in the cost of an EpiPen. Laws that would require drug companies to disclose information about their pricing decisions were proposed in several states, and a bill was introduced at the federal level with similar requirements. Even with those high profile stories making headlines, only one pricing disclosure law successfully passed this year – Vermont. That law requires a select group of manufacturers to provide information about the factors related to price increases.

A handful of former Insys employees had an eventful year. A former sales representative entered a guilty plea to charges of fraud, and a district sales manager and a several of top executives were all arrested on charges they paid kickbacks to doctors. The drug at the center of the charges is the opioid painkiller, fentanyl. Prosecutors and enforcement agencies claim the individuals offered a variety of kickbacks to doctors to increase prescriptions and encouraged them to prescribe it for unapproved uses.

2016 was an active year for settlements related to bribery cases. GSK, AstraZeneca, SciClone, and Novartis all entered into settlements with the SEC over activities conducted by subsidiaries in China. Orthofix and Teva both set aside cash in anticipation of resolving the FCPA-related charges. Olympus entered into a $22.8 million settlement with the DOJ to resolve charges that a subsidiary covering Latin America paid bribes to healthcare professionals working in government facilities in order to increase sales of product.

We saw a couple of legal “victories” for the industry in the debate over sharing truthful off-label information. In the Amarin case, the FDA decided not to appeal a judge’s decision that allowed the company to share truthful off-label information about its fish oil product. In addition, in proposed jury instructions for a medical device case, the DOJ indicated that it is “not a crime for a device company or its representatives to give doctors wholly truthful and non-misleading information about the unapproved use of a device.”

With a string of legal decisions favoring the industry, the FDA held a public forum in November concerning the ability of drug and device makers to share off-label information. The primary topic was whether the agency needs to revise its regulations considering recent legal decisions and the forum was attended by various stakeholders representing both sides of the argument.

With that, we complete our look back at 2016 and the stories that made headlines in the world of life science compliance. It was an eventful year, and everyone at the Compliance News in Review is excited to see what the new year holds. Thanks for joining us throughout the year and best wishes for a happy, healthy, and compliant 2017!

Compliance News in Review, December 12, 2016

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

If you’re dancing “The Beagle,” and you can’t break away from all of the movies starring Candace Cameron Bure on the Hallmark Channel, it can only mean one thing; it’s Christmas time! Despite what Staples would have you believe, THIS is the Most Wonderful Time of the Year. Before you fill your heads with dreams of sugarplums, we have a quick yuletide tale to share. Gather round friends to hear the tome; our newsy, Compliance News in Review Christmas poem.

T’was the News before Christmas, and all through the land,

Our readers waited for the first story at hand.

The story was chosen with the utmost of care,

In the hopes of bringing joy and not causing despair.

In Congress a healthcare bill was just passed,

But not without a change that left some hopes dashed.

Despite efforts to exempt, companies will still report

Payments for textbooks, reprints and speaking fees of a sort.

Senators exclaimed the payments we must heed

With the exemption removed, the bill passed with ease.

With the healthcare bill passed and well on its way,

We will move on to news from Californ-i-a.

Away went a bill in the last governing session,

Requiring disclosure of drug pricing information.

Not one to give up, an intrepid senator said,

“I’ll make minor changes. This bill is not dead!”

Change his bill he did, and returned it to the floor.

Companies must report price hikes of 25% or more. (if passed)

Then over at Teva there arose such a clatter!

We wondered out loud what could be the matter?

After one bribery investigation and setting aside cash

A tip came in – to Romania Teva should dash!

Bribes of travel and consulting fees were paid.

Teva is investigating all of these claims.

On the “nice” list of St. Nick we all hope to be,

But this group of execs will be found on “naughty.”

Six from Insys were arrested for inducements

Paid to docs to write scripts for unapproved uses.

The former CEO is one of the six, yes really.

His lawyer exclaimed he would plead “not guilty.”

Others in trouble are from marketing and sales.

Don’t buy the business is the moral of this tale.

With that last story our tale must come to an end.

We’ve enjoyed sharing it with you our dear friends.

So until we return with more news and insights,

Merry Christmas to all, and to all a good night!

Compliance News in Review, November 18, 2016

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

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!

Discount Registration: Pharmaceutical and Medical Compliance Congress

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

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

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

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!

The Right Stuff: Compliance Training in Preparation for Your Company’s First Product Launch

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

A first product launch is an exciting and overwhelming time for any life sciences company. So much to do, and what seems like so little time to do it – especially if you are a compliance department of one or two people. As employees are brought on board in support of the launch, planning and implementing an initial compliance training curriculum is a critical task. You need to cover all the essential bases and topics, and direct the training to the appropriate audiences so individuals aren’t burdened and distracted by messages and information that may not be applicable to their job duties.

With that in mind, the team at PharmaCertify™ has compiled a list of suggested topics and audiences for any company working toward an initial product launch.

Topic 1: Code of Conduct
Audience: All Employees

Good code of conduct training introduces employees and external contractors to the behavioral expectations your company has established. It also provides a foundation for understanding the requirements of working in such a heavily-regulated environment. We could fill an entire blog entry with instructional tips for building effective code training, but for now, we’ll make this one suggestion – make it more meaningful with scenarios that demonstrate how the concepts are manifested in their daily activities. Learners need to relate to the information being presented in order for it to stick.

If your company has not yet developed a code of conduct, see topic two.

Topic 2: Overview of Healthcare Compliance
Audience: All Employees

All employees must be aware of the laws, regulations, and guidance documents related to working for a pharmaceutical or medical device company. If your company doesn’t have a code of conduct, or the code doesn’t include basic information about the laws affecting the industry, a compliance overview course is especially necessary to communicate the concepts they need to know. If you do have a code of conduct, consider the idea of narrowing the audience to the commercial, medical affairs, regulatory, and communications groups.

Topic 3: Interactions with Healthcare Professionals
Audience: Sales, Marketing, Medical Affairs, and Customer-Facing Regulatory

Employees whose job responsibilities involve interacting with healthcare professionals (HCPs) on some level need training to ensure those interactions are in compliance with laws, regulations, and company policy. The training should include topics such as the rules associated with providing gifts and meals; the use of HCP consultants; proper conduct during speaker programs and advisory boards, and interactions at medical congresses or other scientific meetings.

Topic 4: Good Product Promotion
Audience: Sales and Marketing

Sales and marketing teams need detailed training regarding the regulations that govern prescription drug and device promotion. Focus your promotional training on how the regulations affect both verbal and written promotional statements. It should include topics such as what constitutes promotional statements versus medical information; what is a proper promotional statement (i.e., accurate, balanced, and truthful); FDA guidance on dissemination of reprints; and the use of social media.

Topic 5: PDMA and Drug Sample Management
Audience: Field Sales

If samples are going to be a component of the product program, training regarding the requirements of the Prescription Drug Marketing Act (PDMA) is needed before the sales representatives receive any of the samples for distribution. The training should be twofold though and include information about inventory management, and your company’s sample documentation processes – a topic just as important for medical device companies as well.

Topic 6: HIPAA
Audience: Sales, Medical Affairs, and Any Group Interacting with Patients or Handling Patient Information

The protection of patients’ personal information is a hot button issue, so you need to ensure those who handle, or who may be exposed to that information, are aware of their responsibilities regarding confidentiality. In addition, credentialing requirements at hospitals and other facilities now require anyone doing business in those facilities to be trained on the requirements of HIPAA and the protection of personal health information. In fact, if your sales representatives are going to be selling in a hospital environment, you will want to add Bloodborne Pathogens and Aseptic Technique training to their curriculum as well, but we will save that for our blog entry on the rise of credentialing and its requirements.

More Information

While the above list of topics constitutes a strong compliance training foundation for any company moving toward its first product launch, the topics and audiences may need to be tweaked based on your particular product and product indication.

The PharmaCertify™ team of compliance subject matter experts and instructional designers are here to help and we are making information available to you. To see an expanded list of the suggested content for each of the topics listed above, contact Sean Murphy, Product and Marking Manager at smurphy@nxlevelsolutions.com, or 609-483-6876.

Thanks for reading and stay compliant!

Lauren Barnett, Compliance Content Specialist, PharmaCertify™ by NXLevel Solutions

Compliance News in Review, July 5, 2016

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

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!