compliance

The 3rd Annual Life Science Compliance Training Conference: A Preview

NXLevel Compliance Team , , , , , ,

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The 3rd Annual Life Science Compliance Training Conference opens Wednesday, June 6, 2018  at the Hilton Garden Inn in Chicago. The PharmaCertify team will be there to catch up with clients and colleagues, and share demos of our newest compliance training solutions. I also always welcome the opportunity to hear from those who are directly responsible for building and maintaining a modern and effective compliance curriculum. It’s always an enlightening experience. Here are a few presentations I am looking forward to in particular:

Day One

Structure and Delivery of Compliance Content for Executive Level

After opening remarks from PharmaCertify’s own Dan O’Connor, who is chairing Day One, the conference begins with this compelling panel presentation. Recent enforcement headlines, and an increasing number of presentations by regulators at large compliance congresses, highlight the importance of training C-Suite executives in compliance. But what topics are most critical and what tools are most effective? I am anxious to hear what delivery and engagement tools the presenter’s company uses to help support and encourage a strong “tone from the top” as part of the effort to build a stronger compliance culture throughout the organization.

Adapting Compliance Training Methods and Materials Based on Evaluated Risk
Gary Mendelsohn, Astellas

Data is trending for good reason. The data gained through extensive auditing and monitoring is an important tool for evaluating whether compliance training methods and content need to be modified to better address organizational risks. This is a timely topic as life sciences companies continue to look to the data for answers on how to better target their training.

Alignment of Compliance Training with Current Areas of Inspection
Kelly Tope, Zimmer Biomet

A medical device perspective on compliance training is always welcome in compliance conferences. While dealing with some of the same challenges of their pharmaceutical counterparts, medical device professionals face unique challenges due to the nature of their HCP interactions and reimbursement arrangements. This session should provide helpful information for both sides of the life sciences fence, as common and industry-specific settlements are reviewed for training topic relevance.

Case Study: Providing Employees Access to Performance and Development Resources
Jackie Bauer and Stacey Leonard, Abbvie

When evaluating a compliance conference agenda, my eyes are always drawn to the words, “case study.” Attendees are there to hear what techniques, programs, and tools work for their peers and case studies offer the best framework for doing so. With the phrase “continuous learning” in this session description, my interest is piqued even more by the potential for learning what tools and materials the presenter deploys on a regular basis to enhance learning and increase retention of key content.

Day Two

Panel: Building Employee Accountability to Support Compliance Training
Kim Ingham, Merck, Sharon Delgado, Orexigen Therapeutics Inc., Susan Novak, Celgene

Industry professionals have been espousing the importance of a “culture of compliance” for about as long as compliance has been a focus for the life sciences. By contrast, a “culture of accountability” is a term I have not seen applied to the compliance space, and at first glance opens the door for exciting possibilities. This session promises “varied perspectives on how to build and engage staff in heightened levels of accountability,” and I am excited to hear what strategies the presenters utilize to encourage accountability across each of their three companies.

Advanced Adult-Learning Practices for Heightened Engagement in Compliance Training
Abby Talanca, Johnson & Johnson

As compliance training tools have advanced, on-going research into adult learning practices has led to the utilization of more effective development methods and delivery mechanisms to enhance learning. Based on the agenda description for this presentation, I will be curious to hear exactly how the Johnson & Johnson compliance team integrates modern methods like continuous learning into their curriculum to increase retention and maximize on-the-job application of the knowledge gained through the training.

Train the Trainer Workshop: Increasing Connection & Retention in Compliance Training
Mona Kay Gorman, Valeritas

Compliance training curriculums are often developed with an understandable focus on internal stakeholders and with a lack of attention paid to the internal trainers – those responsible for delivering the training. Mona Kay Gorman brings extensive experience delivering engaging live compliance training, and hearing her suggestions for how to improve the skills of trainers so workshops and courses are more engaging and effective should prove valuable and worthwhile.

Proactive Approach to Analyzing Compliance Data for Preventative Training
Kevin Ryan, Novo Nordisk

Extending the topic data analysis to the second day, the description for this session promises a review of the data sources available to compliance teams, and how to use that data once its collected to conduct gap analysis studies, and identify trends and potential compliance risks. Data collection and analysis offers forward-thinking compliance training professionals a critical tool for identifying trends and potential risks, then using that information to target training and segmenting trainee groups more accurately. It’s an important and timely presentation.

Next Stop: Chicago

The agenda for the 3rd Annual Compliance Training Conference offers a great lineup of industry professionals sharing the latest in training best practices, suggestions, and tips. If you’re attending, stop by the PharmaCertify booth in between sessions to see demos of our newest compliance training solutions. If you can’t attend this year, watch for my blog post with conference highlights right here on the Compliance Training Insights Blog shortly after we return.

Thanks for reading!

Sean Murphy
Product and Marketing Manager
PharmaCertify by NXLevel Solutions

“Dear Connie the Compliance Training Specialist” is back!

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

Welcome to this edition of “Dear Connie the Compliance Training Specialist,” where we answer questions about timely compliance topics and delve into the best training for reducing risk.

This week: raising knowledge retention at the next POA.

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Dear Connie,

During the compliance portion of our last Plan of Action meeting, I introduced several scenarios for group discussion with the hope of making the session more engaging. For the most part, I think it was more successful than just reviewing a slide deck (our usual approach), but not everyone was engaged and I’m not sure they’re going to remember the key points. Any suggestions for our next workshop?

Signed,

Bewildered in Bridgewater

Dear Bewildered,

Kudos to you for making the effort to move beyond the “PowerPoint Overload” approach to live compliance training. To engage the entire audience, I suggest you “gamify” the discussion and have everyone team up to solve scenario-based challenges. Research has shown that creating a competitive environment raises the retention of key lessons and makes the content stick with the learners.

Here are a few suggestions that can add a level of interactivity, even if the time allotted to compliance is limited:

Form Teams

Competition is more fun and learning is enhanced when groups of participants work together to solve the scenario. Instead of asking individuals in the audience to give their opinion, create teams of participants based on regions, products, or any number of qualifiers. To save time at the session, create the teams ahead of time, in the planning stage.

Add Activities

Don’t just ask the teams to present their best suggestions for a scenario. Add activities that stimulate cooperation within the team. For instance, you can employ a card-sort exercise with scenario “flashcards” the teams sort into two piles, e.g., “permissible” and “not permissible.”

Teams can also compete against one another to solve a scenario-based “mystery” using their understanding of compliance best practices and company policies. Provide clues (emails, call transcripts, receipts, and text messages) during the workshop or ahead of time via email.

The activities can be developed in analog (paper-based) form or electronically through an online gaming platform or outside vendor.

Keep Score

Enhance the competitive spirit even more with a leaderboard that you update manually or electronically. Display the board continuously during workshop, or only after each activity is completed. If you send out questions in the weeks before the workshop, tell the learners they get points for how quickly they respond and for accuracy. Add those scores to the leaderboard as well.

Remember the Debrief

Don’t forget to leave time to debrief the audience once the activities are completed. You need to make sure the nuances and “gray areas” are understood, and the participants understand which company policies to reference for on-going guidance around the topics that were covered.

These are just a few tactics for raising the retention rate and “making live compliance learning stick.” My friends here at the compliance training division of NXLevel Solutions have experience creating compliance workshops for a range of life sciences clients. Feel free to contact them at 609-483-6875 to hear more ideas.

Thanks for the great question!

Connie the Compliance Training Specialist

Compliance Trends 2018: Our Point of View

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

The festivities have ended and a shiny new year is upon us, so we are switching hats – from party to prognostication – to delve into what we see as the hot compliance topics and trends for 2018. Based on our reading of the enforcement tea leaves, several 2017 topics should remain at the forefront, but our prediction on the level of activity emanating from the OPDP has changed from last year. So if you’ve resolved to stay up-to-date on all the compliance news fit to blog this year, what better way to start than with this look ahead.

We expect funding for patient assistance organizations, which are charities that provide financial assistance to patients to help cover the cost of medications, to be a trending topic in 2018. In 2016, federal agencies started to focus on the topic and issued subpoenas related to support provided to these charities. In 2017, two companies entered into settlements with the government over that funding. The government considers the practice to be a violation of the Anti-Kickback Statute because the funding offsets the co-pay of patients who participate in government healthcare programs.

Donations to charities that assist with medication costs are permitted, but assistance cannot be directed to patients who are prescribed the donating company’s medications. We would not be surprised to see the government take more of an interest in the financial relationship between the industry and charitable patient organizations this year. Training must emphasize the need to maintain appropriate independence between the company and the patient organizations it chooses to support.

In 2017, a small group of states passed laws related to price reporting, sales representative registration, and physician payment caps. That trend should continue in 2018 and the laws will most likely be focused on pricing transparency, as opposed to spend transparency, which was more common a few years ago. Expect more states to follow New Jersey’s lead and implement broader restrictions and caps on payments to healthcare professionals. The law is intended to combat the growing opioid addiction crisis.

2017 was a surprising year for the Office of Prescription Drug Promotion (OPDP). After a flurry of letters at the end of 2016, we expected the agency to continue that trend into 2017, but only four letters were issued the entire year. That is a record low. Don’t expect a dramatic increase this year.

The letters that were issued last year were focused on false and misleading statements related to risk and omission of risk. Two industry settlements in 2017 included charges of failure to disclose risk in violation of the Risk Evaluation and Mitigation Strategy, so emphasizing the importance of fair balance and truthful, accurate promotional statements when training sales representatives is critical.

On the global front, we would not be surprised to see an uptick in Foreign Corrupt Practices Act enforcement following the implementation of new processes that reward companies for self-disclosing potential violations and cooperating with investigations.

With that, we end this “preview” edition of the Compliance News in Review. To be automatically notified when we post new editions of the News in Review, conference highlights, or compliance training tips, just click the “follow” button on the right side of this page.

Have a safe and compliant 2018!

The 2017 Compliance Year in Review!

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

As the year winds to a close, we take a break from the hustle and bustle of holiday preparations to reflect on the 2017 trends, topics, and focal points from the world of life sciences compliance. It’s been a busy year, with some expected updates, along with a few surprises, filling our News in Review missives from month to month. So, grab a cup of egg nog, fire up the Yule Log on YouTube, and enjoy this “year in review” edition of the Compliance News in Review.

Drug pricing transparency was a hot topic at the end of 2016, and the trend carried through 2017. The rules for Chicago’s new sales representative licensure law, which is intended to help combat opioid addiction, went into effect. The law requires representatives to obtain a license to sell products in the city and to document their interactions with healthcare professionals. In California, drug manufacturers must now notify the State and other payers in advance when they intend to raise the wholesale acquisition cost of a drug over a certain percentage, and when new drugs are expected to have a wholesale acquisition cost that exceeds the Medicare Part D specialty drug threshold. Nevada passed similar legislation, but its law focuses on diabetes drugs. Nevada also requires sales representatives to be licensed and provide reports of their interactions with HCPs. Finally, Louisiana also jumped on the pricing transparency train.

In an effort to combat the opioid crisis,  Governor Christie in New Jersey issued rules that cap payments made to healthcare professionals by pharmaceutical companies.  Maine passed a gift ban law similar to the existing Minnesota law and, not surprisingly, we heard from Vermont in 2017. The attorney general there is reportedly investigating whether drug and device companies are adhering to the state’s HCP gift ban law.

Not all state-level action was successful. Missouri’s proposed price transparency law did not pass during the past legislative session, and a bill in California to restrict gifts and payments to HCPs passed the state Senate, but was rejected in the Assembly.

Pharmaceutical support for patient assistance charities was another 2016 hot topic that continued through 2017.  An IRS investigation into one of the charities focused on whether it provided an improper benefit to pharmaceutical donors by using the donations to purchase the drugs manufactured by those same companies. Support of patient assistance charities also figured into one company’s healthcare fraud criminal and civil settlement with the government.

2017 was a quiet year for the Office of Prescription Drug Promotion (OPDP). During December of 2016, the agency dropped a flurry of letters, but 2017 will likely see record low in activity with only three letters being issued so far for the entire year.

This was an interesting year in bribery and corruption enforcement. It began with a bang in January as the Serious Fraud Office entered into its first major Deferred Prosecution Agreement. With a changing of the guard in the U.S., FCPA actions were more subdued, but the diagnostic test company, Alere, settled with the Securities and Exchange Commission over improper payments to foreign officials allegedly made by its Colombian and Indian subsidiaries.

The Department of Justice (DOJ) published its Compliance Program Evaluation Guidance in 2017. The document offers details on what the agency considers to be an effective compliance program. Perhaps most notably, the DOJ made its Foreign Corrupt Practices Act Pilot Program permanent. The pilot program ended in early 2017, but it was effectively made permanent with the announcement of a new FCPA Enforcement Policy. Like the pilot program, the new policy encourages companies to self-report possible FCPA violations and rewards companies for their  cooperation during investigations.

With that, we close out another issue of the Compliance News in Review, and another year in the wonderful world of life sciences compliance. We look forward to keeping you up-to-date on all compliance news fit to blog in 2017 and continuing to provide you with an ever-expanding suite of PharmaCertify compliance training products and services.

Thank you for reading. Have a warm and wonderful holiday season and a happy New Year!

Open Payments Funding and Another Kickback Case in the News

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

An Open Payments letter from two senators, a list of diabetes drugs from Nevada, near silence from the Office of Prescription Drug and Promotion (OPDP), and an unsealed kickback case…all in this edition of the Compliance News in Review.

Thanksgiving is just around the corner! There’s nothing like a day of food, family, friends, and parades (and of course, football!) to kick off the holiday season. Can’t you just smell the turkey and fixings permeating the hallways and your olfactory senses now? Before we go unpack our “Thanksgiving pants,” we’ll leave you with a different type of tasty morsel: a new edition of the Compliance News in Review. Bon appetit!

Senators Richard Blumenthal and Chuck Grassley don’t want to see CMS’s Center for Program Integrity (CPI) left at the kids’ table. They sent a letter to the acting Health and Human Services Secretary urging that funding for the CPI be made a priority. The CPI is responsible for managing the Open Payments database. The letter includes references to “recent reports that have raised concerns about the effect payments to health professionals may have on opioid prescribing practices, which in many ways has exacerbated this ongoing public health epidemic.”

Nevada’s Department of Health and Human Services published its list of three dozen diabetes drugs that are subject to the State’s new transparency law. Manufacturers with a drug on the list will have to report a variety of financial information, including costs associated with production the drug; rebates and coups offered; and profits earned from the drug. Regulations for reporting the information are still pending.

Will the OPDP pass on dessert at Thanksgiving Dinner? OPDP is on pace to issue a record low number of letters this year. So far, only two letters have been issued. In 2016, the agency issued five in the first six months, then in December, it issued six more. The letter count has steadily declined over the last sixteen years. Will 2017 will be a record low?

On the social media front, Twitter upped its character limit to 280, and according to social media manager, Andrew Grojean, pharmaceutical marketers should take advantage of the expanded word count. Grojean says the change does not solve all the issues related to use of the platform, but it provides more freedom and flexibility, as well as more space for the required fair balance.

Did Eli Lilly over stuff the turkey? A recently unsealed whistle blower case alleges that the company provided kickbacks to boost sales of its drugs. According to the suit, the company offered nursing services to HCPs through a third-party to induce doctors to prescribe three of its drugs. Allegedly, the nurses essentially acted as sales reps even though they were supposed to be providing independent medical advice and disease state education.

With that, we end this holiday edition of the Compliance News in Review. In the spirit of the season, we are thankful to all who take the time to read our tome on a regular basis, and as always, we invite you to contact our editor, Sean Murphy, with your feedback. He can be reached at smurphy@nxlevelsolutions.com.

Have a fun and festive Thanksgiving holiday!

18th Annual Pharmaceutical and Medical Device Compliance Congress: A Preview

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

PCF’s annual Pharmaceutical and Medical Device Compliance Congress kicks off next week. The conference offers attendees the rare opportunity to network with industry leaders and hear their thoughts and suggestions on the bevy of topics and regulations affecting those who work in the pharmaceutical or medical device compliance field. Narrowing the list of impressive panels and sessions down to a manageable schedule may seem overwhelming, but we’ve perused the agenda for what we are looking forward to the most:

Day 1, Monday November 6, 2017

Keynote: OIG Update
Hearing the list of topics that led to settlements and the OIG’s fiscal year 2017 workplan from Mary Riordan, Senior Counsel, Office of Inspector General, Department of Health and Human Services is always valuable for anyone responsible for rolling out compliance training. We are also looking forward to hearing how the agency expects to apply information from the Compliance Program Effectiveness Resource Guide released earlier this year as it conducts investigations.

U.S. Attorney’s Roundtable
While we expect to hear about topics such as off-label promotion, we look forward to hearing what the U.S. Attorneys say about the emerging trend of investigating manufacturer relationships with patient assistance charities. Several companies have been subpoenaed for information about these relationships. One company recently entered into a Deferred Prosecution Agreement, as well as a Corporate Integrity Agreement, after being accused of paying kickbacks to a patient assistance charity.

Chief Compliance Officer Roundtable
For those working in compliance for emerging companies, this session offers an opportunity to learn what risks their brethren from larger companies are facing so they know where to focus their priorities for the upcoming year. With Arjun Rajaratnam, from Smith & Nephew, joining the roundtable, medical device company representatives should also find the information worthwhile and relevant.

Day 2, Tuesday November 7, 2017

HCP Engagement: The Road to Proactive Risk Management

The title is intriguing and we’re curious to know what steps industry professionals like Tom Glavin of Olympus and Michelle Murphy of Regeneron utilize to change their corporate cultures and convince leadership to shift to a more proactive model for addressing risk.

Managed Market Considerations for Hub and Specialty Pharmacy Arrangements

Training and messaging for those who work with specialty pharmacies is a topic not often addressed in these forums, so hearing what industry professionals like Terra Buckley of Celgene and Greg Sherman of Gilead Sciences say should be of value.

Compliance Considerations for Small and Mid-Sized Pharma and Medical Device Companies

Here is a direct opportunity for attendees from emerging companies to evaluate their programs against companies of a comparable size and learn best practices for managing risks with less resources.

Brief Overview of the Policy and Politics of Pharma Pricing

Transparency around drug pricing is a hot topic with state and federal legislators. Learning more about the current laws, as well as what to expect from politicians in an election year, should prove to be valuable when evaluating risk, writing policy, and developing training.

The Exhibit Hall (Especially Booth #112!)

We’re looking forward to catching up with clients and friends (old and new) at the 18th Annual Pharmaceutical and Medical Device Compliance Congress. During the networking breaks, we invite you to stop by the PharmaCertify Booth to see demos of our newest compliance training solutions. Our mission is to help you build a stronger compliance culture and reduce risk, and we welcome the opportunity to show you how we’ve done just that for our clients. While you are there, don’t forget to enter the drawing to win a JBL Flip 4 Waterproof Portable Bluetooth Speaker!

See you in Washington!

Life Sciences Compliance Congress West: A Preview

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

CBI’s 8th Annual Life Sciences Compliance Congress West kicks off in San Francisco in two short weeks. During the packed two-day conference, an esteemed lineup of industry professionals and government regulators will address the emerging risks facing life sciences companies. It’s a great opportunity to share notes and best practices with your peers and industry leaders. If you’re considering attending, we can help with a discount on the registration fee.

In the meantime, we’ve perused the agenda to note the sessions that hold the most interest:

Day 1

Session: Industry’s Guide to GDPR

The General Data Protection Regulation of the European Union, or GDPR, applies to companies that control or process the personal data of EU citizens, regardless of geographic location. That’s a wide reach, and your employees need to understand how their role helps ensure compliance with this new and potentially confusing regulation.

Session: Navigate the Complexities of Patient Assistant Programs (PAPs), Reimbursement Support and Patient Services Compliance in an Era of Ambiguity

Industry assistance for patients is an emerging enforcement area in the U.S. and abroad. Several U.S. companies have received subpoenas from the DOJ centered on their relationship with patients assistance organizations. This session covers the compliance issues related to patient support and the strategies for reducing risk.

Session: Small to Mid-Sized Boot Camp

We may be a little biased on this one, since our own Dan O’Connor, Senior Vice President of PharmaCertify, will join Jim Schneider of Seattle Genetics and Jane Wright-Mitchell of AcelRx to cover compliance governance considerations and key elements of compliance program development. It’s a must-attend for anyone building out a curriculum for an emerging company.

Day 2

Keynote Session: A Journey to the Dark Side of International Business and Steps to Protect Your Organization

Presented by a former FCPA Violator turned FBI/UK Cooperator, the session covers a range of international business practices and pitfalls. We expect topics to include privacy; patient interactions; bribery; and compliance risks when conducting business internationally, all critical information whether you’re updating an existing compliance training curriculum, or building one from scratch.

Session: Operations Management — Align Compliance Strategy with Emerging Risks on the Horizon for 2018

As new life sciences compliance risks emerge, training content, and the methods by which those risks are addressed, need to evolve. This session may offer tips for identifying curriculum gaps as well as the overall program adjustments needed to strengthen your curriculum and reduce risk.

Summary

We’re looking forward to catching up with our friends and clients at the 8th Annual Life Sciences Compliance Congress West. If you’re attending, don’t forget to stop by our booth to say hi and see demos of our newest Compliance Foundations™ eLearning modules, QuickTakes™ reinforcement tools, and compliance workshops. While there, don’t forget to enter our drawing to win a JBL Flip 4 Waterproof Portable Bluetooth Speaker.

See you in San Francisco!

Compliance News in Review, September 22, 2017

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

Reprimands in the UK, opioid manufacturers face another investigatory group, and registration processes for Nevada representatives, all in this week’s Compliance News in Review.

Ready or not, Fall is here! Leaves are turning, football is back, the oppressive heat of Summer is fading, and pumpkin spice everything is available. We are certainly fans of Autumn here in the offices of the News in Review and we’re ready to break out the flannel shirts, boots, and maybe a knit cap to enjoy the cooler evenings ahead. We are also fans of compliance! So, grab a pumpkin spice latte and settle in to this edition of the Compliance News in Review.

A nip in the air, and a nip at the marketing practices of several companies by the ABPI. The industry organization reprimanded Pfizer, Novartis, Astellas UK, Astellas Europe, and TOR Generics for breaches of its Code. Pfizer and Novartis were both cited for misleading promotion, and unclear materials used by representatives. Astellas UK and Astellas Europe voluntarily admitted that prescribing information for several of their products omitted references to adverse events. Lastly, TOR Generics was accused of promoting an unlicensed product, which was expected to be a prescription-only product, in a public magazine.

A new team is investigating opioid marketing. 41 state attorneys general formed a coalition to investigate opioid manufacturers and distributors. The group subpoenaed several top manufacturers, and wholesale distributors Amerisource, Cardinal, and McKesson. The AGs want to know if manufacturers deceived healthcare professionals about product efficacy and addictiveness.

Time to turn over a new leaf in Nevada. The state published draft procedures for the registration of pharmaceutical representatives. Individuals who work in Nevada for at least five days a year and communicate with healthcare professionals, or participate in the activities listed below, must register with the state’s Department of Health and Human Services (DHHS):

  • Marketing of prescription drugs to healthcare providers, pharmacists or pharmacy employees, and employees of medical facilities
  • Meeting with healthcare providers to answer questions about product use and benefits, or to provide discussion and product information and resources to those providers or other decision makers while representing the manufacturer or supporting promotional efforts of the manufacturer
  • Distributing FDA regulated product samples and product information

These activities are excluded under the law:

  • Attending a conference in Nevada that is not exclusively marketed to Nevada healthcare professionals
  • Activities related to clinical trials, investigational drugs, or Risk Evaluation and Mitigation Strategies
  • Activities performed by wholesale distributors who do not represent a single manufacturer

Companies are required to notify DHHS as employees are hired and terminated, and employees must be registered with DHHS within 30 days of hire.

With that, we wrap up this edition of the Compliance News in Review and head outback to roast marshmallows and make smores! If you can’t join us by the fire pit, we’ll catch you back here for our next issue.

Thanks for reading!

Compliance News in Review, August 21, 2017

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

Opioid investigations expand; the FDA plans drug advertising studies; DOJ units team up for healthcare sector FCPA investigations; the Sunshine Act is out in South Korea; and a big settlement could signal a new enforcement avenue; all casting a shadow in this edition of the Compliance News in Review.

Here comes the sun, and the moon, and a shadow. It’s eclipse fever! The total eclipse over the continental U.S. was one for the record books, and had people flocking to places like Alliance, NE, Hopkinsville, KY, and Red Bank, SC. If you couldn’t make it to the path of totality this time, you have seven years to plan for the next event.

The shadow of the investigation into the business practices opioid makers use continues to spread. In an SEC filing, Mylan revealed it has received a subpoena from the Department of Justice (DOJ) for information about its opioid business practices. The company, a relatively small player in the opioid market, said it is cooperating with the request.

The FDA, hoping to shed some light on disclosures in drug advertising, has proposed two studies that will focus on how safety information is perceived. The first study will involve patient recall of important safety information presented in print, direct to consumer ads. The second will include oncologists, primary care physicians, and non-oncology mid-level practitioners. It will focus on the effectiveness of disclosures related to preliminary or descriptive clinical and scientific data.

The DOJ’s Criminal Fraud Section announced a partnership between its Healthcare Fraud Unit’s Corporate Strike Force and Foreign Corrupt Practices Act (FCPA) prosecutors. Speaking at an anticorruption conference, the acting chief of the Criminal Fraud Unit said, “This increased coordination will ensure that companies, their executives, employees, and agents are held to account for the payment of bribes and kickbacks to foreign and domestic officials and actors regardless of the market.” He also urged companies to empower compliance teams to take steps to make their anticorruption programs better.

South Korea is the latest nation to bring sunshine to industry-physician relationships. The country has enacted a transparency law like the U.S. Sunshine Act. The law applies to pharmaceutical and medical device companies, and covers a wide range of recipients including pharmacists, herbalists, and acupuncturists, in addition to physicians. Transfers of value covered by the new law include product samples, academic conference sponsorships, food, beverage, and other items (e.g. pens, notepads). Transfers of value must be reported on one of seven reporting templates, and companies must begin collecting data on January 31, 2018.

Is a bad moon rising over industry relationships with patient assistance charities? Recently, United Therapeutics announced it had reserved $210 million in anticipation of a settlement with the government over activities involving a copay assistance charity. Other companies have disclosed that they are subject to investigations as well. Charities do not face the same restrictions as pharmaceutical companies when offering co-pay assistance and the contributions companies make to charities can be considered kickbacks. According to an attorney with Morgan and Morgan, the United Therapeutics announcement is likely to send “shock waves” through the industry.

With that, we end this shadowy edition of the Compliance News in Review. Until next time, we leave you with a total eclipse of the sun, er…Total Eclipse of the Heart.

Compliance News in Review, July 31, 2017

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

A whistleblower settlement, the effect of a recent cyberattack on one company’s drug supply, transparency in Ontario, and the growth of CME, all served for your approval in this edition of the Compliance News in Review.

It is the quintessential American food, even if it didn’t originate here; it’s the hamburger. Nothing beats a good burger, even during the hot dog days of summer (see what we did there?). The tasty entrée even inspired the bard of gulf and western music, Jimmy Buffet, to write a song extoling its virtues. So, how do you like your burger? With slaw? Kraut? Chili? Our mouths are watering just pondering the possibilities! Before we fire up the grill here at the News in Review World Headquarters, we’ll serve a tasty treat of a different flavor – the latest edition of the Compliance News in Review.

This is hardly minced meat. Celgene has agreed to pay $280 million to settle claims in a whistleblower suit that accused the company of promoting two of its cancer products for off-label purposes. The whistleblower, a former employee, claims the company directly marketed the drugs for the off-label uses and hid risks of blood clots from physicians. Celgene did not admit to wrongdoing in the settlement.

Still in a bit of pickle following the Petya cyberattack, Merck has warned that some drug supplies may be disrupted as it continues to rebound from the attack. The company’s R&D and manufacturing operations have not yet fully recovered and there may be temporary delays in filling orders for some products.

Ontario doctors may be flipping over a recent judicial decision that will allow the payments they receive from the government insurance program to be published. The Toronto Star filed a Freedom of Information Act request to obtain the names of the top 100 billers. The Ontario Health Ministry refused to provide the names, saying it would be an invasion of privacy. Two doctor groups and the Ontario Medical Association also fought the release of names, arguing that doing so “accomplishes nothing other than naming and shaming.” The judges disagreed, saying the “public is entitled to information in the possession of their governments so that the public may, among other things, hold their governments accountable.”

The Accreditation Council of Continuing Medical Education (ACCME) 2016 report on the growth of CME finds an increase in the number of events (7%), as well as an increase in the number of instructional hours (9%). The study also shows the number of activities and interactions has increased steadily since 2010. ACCME President and CEO, Dr. Graham McMahon, noted that there are currently more than 3,000 hours of CME available to healthcare providers.

That brings us to the end of another “well done” edition of the Compliance News in Review. We’ll see you right back here for the next summertime treatise, and in the meantime, we leave you with a few tips for barbecuing the perfect burger (olive oil…who knew?).

Have a great week!